Page 1 of 50 Coverage Policy Number: 0139

Cigna Medical Coverage Policy

Subject Minimally Invasive Treatment of Back and Neck Pain

Effective Date ............................ 7/15/2014 Next Review Date ...................... 7/15/2015 Coverage Policy Number ................. 0139

Table of Contents Coverage Policy .................................................. 1 General Background ........................................... 5 Coding/Billing Information ................................. 30 References ........................................................ 42

Hyperlink to Related Coverage Policies Acupuncture Bone Graft Substitutes for Use in Bone

Repair Botulinum Therapy Discography Intervertebral Disc (IVD) Prostheses Lumbar Fusion for Spinal Instability and

Degenerative Disc Conditions, Including Sacroiliac Fusion

Mechanical Devices for the Treatment of Back Pain

Percutaneous Vertebroplasty, Kyphoplasty, and Sacroplasty

Spinal Orthoses

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna companies. Coverage Policies are intended to provide guidance in interpreting certain standard Cigna benefit plans. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Proprietary information of Cigna. Copyright ©2014 Cigna Coverage Policy TRIGGER POINT INJECTION Diagnostic/Stabilization Phase Cigna covers trigger-point injection(s) of anesthetic and/or corticosteroid (CPT codes 20552, 20553) for diagnosis/stabilization of subacute or chronic back, or neck pain, or subacute or chronic myofascial pain syndrome as medically necessary when pain has persisted despite appropriate conservative treatment, including pharmacological therapy, physical therapy, and/or a home exercise program. A maximum of four injection sessions for diagnosis and stabilization will be covered at minimum intervals of one week when provided to determine whether injections provide therapeutic benefit. Therapeutic Phase Cigna covers therapeutic trigger-point injections of anesthetic and/or corticosteroid (CPT codes 20552, 20553) as medically necessary when prior diagnostic/stabilization injections resulted in a beneficial

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clinical response (e.g., improvement in pain, functioning, activity tolerance) and BOTH of the following criteria are met:

• subacute or chronic back pain, neck pain, or myofascial pain syndrome persists • injections are provided in conjunction with an active treatment program, which may include pain

management, physical therapy, and/or a home exercise program A maximum of six treatment sessions for injection of the same muscle may be covered at a minimum interval of two months, if the preceding therapeutic injection resulted in more than 50% relief for at least six weeks. Cigna does not cover long-term repeated or maintenance therapeutic trigger point injections for any indication because it is considered experimental, investigational or unproven. Repeat therapeutic trigger point injections provided for 12 months or longer may result in medical necessity review. Cigna does not cover dry needling of trigger points for any indication because it is considered experimental, investigational, or unproven. Cigna does not cover ultrasound guidance (76942) for trigger point injections for any indication because it is considered not medically necessary. EPIDURAL STEROID INJECTION / SELECTIVE NERVE ROOT BLOCK Diagnostic Phase: Cigna covers diagnostic epidural steroid injection/selective nerve root block (CPT codes 62310, 62311, 64479-64484) as medically necessary when BOTH of the following criteria are met:

• acute or recurrent cervical, thoracic or lumbar radicular pain (e.g. sciatica) • failure to improve following at least six weeks of conservative management, including pharmacological

therapy, physical therapy, and/or a home exercise program, OR worsening (e.g., incapacitating pain, advancing neurological symptoms) following at least two weeks of conservative management

A maximum of two diagnostic injection treatment sessions may be covered at a minimum interval of two weeks Therapeutic Phase Cigna covers subsequent epidural steroid injections/selective nerve root blocks as medically necessary when prior diagnostic/stabilization injections resulted in a beneficial clinical response (e.g., improvement in pain, functioning, activity tolerance) and BOTH of the following criteria are met:

• cervical, thoracic or lumbar radicular pain (e.g., sciatica) has persisted or worsened • minimum interval of two months between injection sessions

A maximum of four therapeutic injection treatment sessions may be covered for the same diagnosis/condition within a twelve month period, if preceding therapeutic injection resulted in more than 50% relief for at least two months. Cigna does not cover long-term repeated or maintenance epidural steroid injection/selective nerve root block for any indication because it is considered experimental, investigational or unproven. Repeat epidural steroid injection/selective nerve root block provided for 12 months or longer may result in medical necessity review. Cigna does not cover EITHER of the following because each is considered experimental, investigational or unproven:

• Epidural steroid injection/selective nerve root block for acute, subacute, or chronic back pain without radiculopathy (e.g., sciatica)

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• Epidural steroid injection with ultrasound guidance (0228T-0231T) for any indication INTRADISCAL STEROID INJECTION Cigna does not cover intradiscal steroid injection for the treatment of acute, subacute, or chronic back or neck pain because it is considered experimental, investigational, or unproven. FACET JOINT INJECTION Diagnostic Cigna covers a diagnostic* facet joint injection (CPT codes 64490-64495) as medically necessary when used to determine whether chronic neck or back pain is of facet joint origin when ALL of the following criteria are met:

• Pain is exacerbated by extension and rotation, or is associated with lumbar rigidity • Pain has persisted despite appropriate conservative treatment (e.g., nonsteroidal anti-inflammatory

drugs (NSAIDs, exercise) • Clinical findings and imaging studies suggest no other obvious cause of the pain (e.g., spinal stenosis,

disc degeneration or herniation, infection, tumor, fracture) *Note: A facet joint injection performed on the same side at the same level subsequent to a diagnostic injection is considered to be therapeutic; see policy statement below on coverage of therapeutic facet joint injection. Therapeutic Cigna does not cover therapeutic facet joint injection (CPT codes 64490-64495) for the treatment of acute, subacute, or chronic neck or back pain or radicular syndromes because it is considered experimental, investigational, or unproven. Cigna does not cover diagnostic or therapeutic facet joint injection with ultrasound guidance (CPT codes 0213T-0218T) for any indication because it is considered experimental, investigational, or unproven. SACROILIAC (SI) JOINT INJECTION Cigna covers SI joint injection (CPT code 27096, HCPCS code G0260) for the treatment of back pain associated with localized SI joint pathology (e.g., inflammatory arthritis) confirmed on imaging studies. Cigna does not cover SI joint injection (CPT code 27096) for the diagnosis or treatment of acute, subacute, or chronic back pain or radicular syndromes not associated with localized SI joint pathology confirmed on imaging studies because it is considered experimental, investigational, or unproven. Cigna does not cover ultrasound guidance (76942) for SI joint injection for any indication because it is considered experimental, investigational, or unproven ABLATIVE TREATMENT Cigna covers initial percutaneous radiofrequency denervation of paravertebral facet joint nerves (also referred to as radiofrequency neurolysis, neurotomy, facet rhizotomy) (CPT codes 64633-64636) for the treatment of chronic back or neck pain as medically necessary when ALL of the following criteria are met:

• Pain is exacerbated by extension and rotation, or is associated with lumbar rigidity • There is severe pain unresponsive to at least six months of conservative medical management. (e.g.,

pharmacological therapy, physical therapy, exercise) • Facet joint origin of pain is suspected and medial branch block/injection of facet joint with local

anesthetic results in elimination or marked decrease in intensity of pain

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• Clinical findings and imaging studies suggest no other obvious cause of the pain (e.g., spinal stenosis, disc degeneration or herniation, infection, tumor, fracture)

Cigna covers repeat percutaneous radiofrequency denervation of paravertebral facet joint nerves at the same level for the treatment of chronic back or neck pain as medically necessary when BOTH of the following criteria are met:

• At least six months have elapsed since the previous radiofrequency ablation/neurolysis of paravertebral facet joint nerves

• More than 50% relief is obtained, with associated functional improvement, for at least ten weeks following the previous treatment

Cigna does not cover ANY of the following ablative procedures for the treatment of back, or neck pain because each is considered experimental, investigational or unproven (this list may not be all-inclusive);

Pulsed radiofrequency (CPT code 64999) Endoscopic radiofrequency denervation/endoscopic dorsal ramus rhizotomy (CPT code 64999) Cryoablation/cryoneurolysis/cryodenervation (CPT code 64999) Chemical ablation (e.g., alcohol, phenol, glycerol) (CPT codes 64633-64636) Laser ablation (CPT code 64999) Ablation by any method for sacroiliac (SI) joint pain Cooled radiofrequency ablation

Percutaneous and Endoscopic Laminectomy and Disc Decompression Procedures Cigna does not cover a percutaneous or endoscopic laminectomy or disc decompression procedure, including but not limited to the following, because it is considered experimental, investigational or unproven (this list may not be all-inclusive):

• automated percutaneous lumbar discectomy (APLD)/automated percutaneous nucleotomy (CPT code 62287, HCPS codes C2614)

• endoscopic anterior spinal surgery/Yeung endoscopic spinal system (YESS)/percutaneous endoscopic diskectomy (PELD)/arthroscopic microdiscectomy, selective endoscopic discectomy (SED) (CPT code 62287)

• endoscopic disc decompression, ablation, or annular modulation using the DiscFX™ System (CPT code 62287)

• percutaneous laminotomy/laminectomy, percutaneous spinal decompression (e.g., mild® procedure) (CPT codes 22899, 64999, 0274T, 0275T)

• percutaneous laser discectomy /decompression, laser-assisted disc decompression (LADD) (CPT code 62287)

THERMAL INTRADISCAL PROCEDURES Cigna does not cover ANY of the following procedures because each is considered experimental, investigational or unproven (this list may not be all-inclusive):

• intervertebral disc biacuplasty (CPT code 22899) • intradiscal electrothermal annuloplasty (e.g., intradiscal electrothermal therapy [IDET™]) (CPT codes

22526, 22527) • percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), intradiscal radiofrequency

thermomodulation or percutaneous radiofrequency thermomodulation (CPT code 22899, HCPCS code S2348)

• Coblation® Nucleoplasty™, disc nucleoplasty, decompression nucleoplasty plasma disc decompression (CPT code 62287)

OTHER PROCEDURES

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Cigna does not cover ANY of the following procedures because each is considered experimental, investigational or unproven (this list may not be all-inclusive):

• devices for annular repair (e.g., Inclose™ Surgical Mesh System, Xclose™ Tissue Repair System (Anulex Technologies, Inc., Minnetonka, MN)

• endoscopic epidural adhesiolysis (CPT code 64999) • epiduroscopy, epidural myeloscopy, epidural spinal endoscopy (CPT code 64999) • intradiscal and/or paravertebral oxygen/ozone injection • percutaneous epidural adhesiolysis, percutaneous epidural lysis of adhesions, Racz procedure (CPT

codes 62263, 62264) General Background Back pain is a frequent cause of chronic pain and disability, affecting approximately 15% of the U.S. population during their lifetime. Most episodes of low back pain improve substantially within a month without formal medical intervention. In a small minority of patients, back pain may be persistent and disabling. Conservative treatment may include pharmacological therapy (e.g., analgesics, anti-inflammatory drugs, muscle relaxants), exercise, spinal manipulation, acupuncture, cognitive-behavioral therapy, and physical therapy. If these measures are unsuccessful, a number of interventional techniques and procedures may be considered that attempt to target specific structures or spinal abnormalities considered to be potential sources of pain, including back muscles and soft tissues, degenerated facet or sacroiliac joints, spinal canal stenosis, and degenerated or herniated intervertebral discs (Chou et al., 2009). Surgery may be appropriate for medical conditions with remediable underlying pathology (e.g. herniated disc) when confirmed and correlated with imaging findings. There is evidence that surgical discectomy provides significant pain relief in selected patients with lumbar disc prolapse with sciatica that fails to improve with conservative treatment. Discectomy was originally performed in an open operation over the spine called hemilaminectomy, in which the muscles are dissected away from the spine and access to the intervertebral disc is obtained by cutting away a piece of spinal bone (i.e., lamina). This technique remains the treatment of choice in some patients, including those with severe pain or weakness and complicated herniation. Microsurgical discectomy (i.e., microdiscectomy) is a less invasive technique that evolved in an effort to decrease postoperative morbidity and recovery time. Microdiscectomy employs direct visualization but is performed through a smaller (15–25 mm) central incision with the use of an operating microscope. Microdiscectomy outcomes are similar to outcomes seen with open discectomy, and microdiscectomy is considered the standard treatment by which to compare other minimally invasive therapies. Management of back pain that is persistent and disabling despite the use of recommended conservative treatment is challenging. Numerous diagnostic and therapeutic injections and other interventional and surgical treatments have therefore been proposed for the treatment back pain. Choosing Wisely: The following statement is included in the North American Spine Society (NASS) Choosing Wisely recommendations: Don’t recommend bed rest for more than 48 hours when treating low back pain. In patients with low back pain, bed rest exceeding 48 hours in duration has not been shown to be of benefit. Literature Review Injection Therapies Trigger point injections, epidural steroid injections, intradiscal steroid injections, and facet joint injections and blocks have been employed in the treatment of acute, subacute, and chronic back pain. Although the evidence for the efficacy of these diagnostic and therapeutic injections discussed below is not strong, several have gained widespread use as alternatives to more invasive interventions. Trigger point injections involve injection of anesthetic or corticosteroids into distinct, focal hyper-irritable spots (i.e., trigger points) located in a tight band of skeletal muscle. Myofascial pain syndrome is a chronic form of muscle pain centered around trigger points. Pain may be perceived at the site of the trigger point or can be referred to other parts of the body, including the back and neck. Trigger point injections involve injection of local anesthetic, saline, dextrose, and/or cortisone into the trigger point. Fluoroscopic or computed tomography guidance is used with other types of injections used to diagnose and treat back and neck pain (e.g., epidural

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steroid injections) to identify the surrounding structures and ensure accurate needle placement to the target area. Guidance is not needed for trigger point injections, however, since the injection is made into skeletal muscle tissue. A Cochrane systematic review was conducted to determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low back pain (Staal et al., 2008). This updated review evaluated 18 randomized controlled trials (n=1179) of injection therapy involving epidural, facet or local sites (i.e., tender or trigger points) in patients with non-radicular pain. The injected drugs included corticosteroids, local anesthetics, and a variety of other drugs. Overall, the results indicated that there was no strong evidence for or against the use of any type of injection therapy. The authors concluded that there is insufficient evidence to support the use of injection therapy in subacute and chronic low back pain, but it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy. Peloso et al. (2007) conducted a Cochrane systematic review to determine the effects of medication and injections on primary outcomes (e.g., pain) for adults with mechanical neck disorders and whiplash. The review evaluated 36 trials that examined the effects of steroid injections, anesthetic agents, psychotropic agents, and NSAIDs. The authors stated that lidocaine injection into myofascial trigger points appeared effective in two trials. Guidelines on injection therapies, low-back pain, and lumbar fusion published by the American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (Resnick et al., 2005), based on a systematic review of studies evaluating trigger point injections, facet joint injections, and epidural steroid injections, concluded that there is conflicting evidence suggesting that the use of local trigger point injections can be effective for the short-term relief of low-back pain. There are no data to suggest that trigger point injections with either steroids or anesthetics alone provide lasting benefit for patients suffering from chronic low-back pain. American College of Occupational and Environmental Medicine (ACOEM) evidence-based practice guidelines on low back disorders, updated in 2011, state that trigger and/or tender point injections are not recommended for treatment of acute low back pain because there are other more efficacious treatment strategies available. These injections may be reasonable as second or tertiary options for subacute or chronic low back pain that is not resolving with conservative treatment (e.g., NSAID, progressive aerobic exercises, and other exercises). The guideline states that injections should consist solely of topical anesthetic (e.g., bupivacaine), and that there is no evidence that steroid is required for efficacy of these injections. Repeat injections should be linked to subjective and objective improvements and be a component of an active therapy program. The ACOEM guideline recommends an interval of at least three to four weeks between injections. If the results are unsatisfactory after the first set, the injections may be repeated. If subjective and objective improvements are not seen, further injections are not recommended. An American Society of Interventional Pain Physicians (ASIPP) Practice Guideline, Interventional Techniques in the Management of Chronic Pain, Part 2.0 (Manchikanti et al., 2001) includes the following recommendations for trigger point injections:

• In the diagnostic or stabilization phase, a patient may receive trigger point injections at intervals of no sooner than one week and preferably two weeks.

• In the treatment or therapeutic phase (after the stabilization is completed), the frequency should be two months or longer between each injection provided that at least >50% relief is obtained for six weeks.

• In the diagnostic or stabilization phase, the number of trigger point injections should be limited to no more than four times per year.

• In the treatment or therapeutic phase, the trigger point injections should be repeated only as necessary judging by the medical necessity criteria and these should be limited to a maximum of six times for local anesthetic and steroid injections.

• Under unusual circumstances with a recurrent injury or cervicogenic headache trigger point injections may be repeated at intervals of six weeks after stabilization in the treatment phase.

Dry Needling of trigger points has been proposed as a treatment of myofascial pain in various parts of the body, including low back pain. Dry-needling involves the insertion of a needle (acupuncture needle or other type

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of needle) into a trigger point without injecting any medication in an effort to deactivate the trigger point. The needle is not left in place; it is removed and is often followed by stretching exercises. A Cochrane systematic review of acupuncture and dry needling (Furlan, et al., 2003, updated 2011) concluded that there is insufficient evidence to make any recommendation regarding acupuncture or dry needling for acute low back pain. For chronic low back pain, acupuncture and dry needling may be useful adjuncts to other therapies. Because most studies were of poor methodological quality, however, there is a need for higher quality trials in this area. There is insufficient evidence to demonstrate the efficacy of dry needling for the treatment of acute or chronic back pain. Epidural steroid injections/selective nerve root blocks: Epidural injection of corticosteroids has been a widespread practice for many decades used in an effort to reduce inflammation and associated pressure for treatment of back pain with radicular features. Epidural injections may be performed using caudal, interlaminar or transforaminal approaches. Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. On April 23, 2014, a U.S. Food and Drug Administration (FDA) Drug Safety Communication was issued, warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The communication stated that the effectiveness and safety of epidural administration of corticosteroids have not been established, and the FDA has not approved corticosteroids for this use. FDA is requiring the addition of a warning to the drug labels of injectable corticosteroids to describe these risks. Patients are advised to discuss the benefits and risks of epidural corticosteroid injections with their health care professional along with the benefits and risks associated with other possible treatment.

The results of the Cochrane systematic review of injection therapy discussed above (Staal, et al. 2008) indicated that there was no strong evidence for or against the use of any type of injection therapy. The authors concluded that there is insufficient evidence to support the use of injection therapy in subacute and chronic low back pain, but it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy. Novak et al. (2008) conducted a systematic review to evaluate the evidence in support of guidelines on frequency and timing of epidural steroid injections in order to help determine what sort of response should occur to repeat an injection. The review included 11 randomized controlled trials, one prospective controlled trial, and two prospective cohort studies. The authors stated that many of the problems with this type of research stem from a lack of understanding of the underlying mechanisms of radicular pain and a lack of understanding of how epidural steroid injections provide an effect. The underlying mechanism of glucocorticoid activity is not clearly understood, and there is no indication for repeat injection based solely on the characteristics of the medication itself. The authors concluded that there is limited evidence to suggest guidelines for frequency and timing of epidural steroid injections or to help define an appropriate partial response that would trigger a repeat injection. Research suggests that repeat injections may improve outcomes, but conclusions cannot be made due to methodological limitations of the available evidence. The authors concluded that there does not appear to be any evidence to support the common practice of a series of injections. The American Society of Interventional Pain Physicians (ASIPP) Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain were published in 2013, based on a systematic review of the literature utilizing Institute of Medicine criteria (Manchikanti et al.). The quality of each article was assessed by Cochrane review criteria for randomized trials, Newcastle-Ottawa Scale for observational studies, and Quality Appraisal of Reliability studies checklist for diagnostic accuracy studies. Meta-analysis was performed when the predetermined minimum number of studies was available, and finally, analysis of evidence was based on U.S. Preventive Services Task Force criteria. The analysis was conducted using three levels of evidence, good, fair, and limited or poor, in all systematic reviews. The guideline states that because substantial differences are described in the literature regarding the technique and outcomes among the three approaches to epidural injections, caudal, Interlaminar, and transforaminal injections are considered separately. In addition, because the response to epidural injections for various conditions (disc herniation and/or radiculitis, discogenic pain without disc herniation, spinal stenosis, and post surgery syndrome) is variable, outcomes are assessed based on pathology for each approach.

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The guideline includes the following recommendations: Low back pain:

• The evidence for caudal epidural, interlaminar epidural, and transforaminal epidural injections is good in managing disc herniation or radiculitis; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal and lumbar interlaminar epidural injections, and limited with transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections.

• The recommendation for epidural injections for disc herniation is that one of the three approaches may be used; for spinal stenosis any of the three approaches are recommended; whereas for axial or discogenic pain, either lumbar interlaminar or caudal epidural injections are recommended. However for transforaminal the evidence is limited for axial or discogenic pain and post surgery syndrome.

Neck pain • The evidence is good for therapeutic cervical interlaminar epidural injections for cervical disc herniation

or radiculitis; whereas, it is fair for axial or discogenic pain, pain of spinal stenosis, and pain of post cervical surgery syndrome.

• Cervical interlaminar epidural injections are recommended for patients with chronic neck and upper extremity pain secondary to disc herniation, spinal stenosis, and post cervical surgery syndrome.

Thoracic pain • The evidence for thoracic epidural injection in treating chronic thoracic pain is fair. • Thoracic epidural injections are recommended for thoracic discogenic, disc-related, post surgery

syndrome, or spinal stenosis pain. The ASIPP guideline includes the following recommendations for frequency of caudal, interlaminar and transforaminal epidural injections:

• Diagnostic phase: patient may receive two procedures at intervals of no sooner than two weeks or preferably four weeks

• Therapeutic phase (after the diagnostic phase is completed), suggested frequency should be two months or longer between each injection, provided that > 50% relief is obtained for two months

• If neural blockade is applied for different regions, they may be performed at intervals of no sooner than one week and preferably two weeks for most types of procedures.

• The therapeutic frequency may remain at intervals of at least two months for each region. It is further suggested that all regions be treated at the same time, provided all procedures can be performed safely.

• In the treatment or therapeutic phase, the epidural injections should be repeated only as necessary according to medical necessity criteria, and it is suggested that these be limited to a maximum of four times per year.

• Cervical and thoracic regions are considered as one region and lumbar and sacral are considered as one region.

The ACOEM evidence-based practice guidelines on low back disorders 2011) state that epidural glucocorticosteroid injections are an option for acute or subacute radicular pain syndromes. The injection may provide short-term improvement to allow time to determine whether conservative care will succeed. Epidural steroid injections may be appropriate for radicular pain syndromes lasting at least three weeks, when there is no evidence of trending towards spontaneous resolution following treatment with NSAIDs. A second epidural steroid injection is not recommended if following the first injection there has been resolution of the symptoms of the acute radicular pain syndrome, particularly resolution of leg symptoms, or a decrease in symptoms to a tolerable level. If there has been no response to a first epidural injection, there would be no recommendation for a second injection. In patients who respond with three to six weeks of temporary, partial relief of leg pain, but who then have a worsening of leg pain and function, and who are not yet interested in surgical discectomy; a repeat epidural steroid injection is an option. Generally, there are not benefits beyond three injections for a given episode of radicular pain. The guideline also states that epidural steroid injections may be considered as a second-line treatment for acute flare-ups of spinal stenosis, when symptoms have persisted for one to two months despite treatment with NSAIDs and exercise. Epidural steroid injections are not recommended for acute, subacute or chronic low back pain in the absence of significant radicular symptoms.

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The ACOEM evidence-based guideline on cervical and thoracic spine disorders (2011) states that an epidural glucocorticosteroid injection is an option for acute or subacute radicular pain syndromes. This is a consensus-based recommendation; although the evidence was considered insufficient. Epidural glucocorticosteroid injections are not recommended for acute, subacute or chronic cervical pain in the absence of significant radicular symptoms, or for chronic cervicothoracic pain with radicular symptoms, due to insufficient evidence. ` The AANS guideline on injection therapies, low-back pain, and lumbar fusion (referenced above) concluded that there is no meaningful evidence in the medical literature that the use of epidural injections is of any long-term value in the treatment of patients with chronic low-back pain. The literature does indicate that the use of lumbar epidural injections can provide short-term relief in selected patients with chronic low-back pain. The American Society of Anesthesiologists has not published guidelines specific to the treatment of back or neck pain, but a practice guideline for chronic pain management was published by the ASA Task Force on Chronic Pain Management and the American Society of Regional Anesthesia (ASRA) and Pain Medicine in 2010. The guideline was based on scientific evidence, opinion-based evidence (i.e., expert opinion, membership opinion, and informed opinion). The level of evidence for individual recommendations is not specified. This guideline states that epidural steroid injections with or without local anesthetics may be used as part of a multimodal treatment regimen to provide pain relief in selected patients with radicular pain or radiculopathy. An assessment of the use of epidural steroid injections to treat radicular lumbosacral pain was published by the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (Arnon et al., 2007) Recommendations and evidence were classified as follows:

• A. Established as effective, ineffective, or harmful for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies.)

• B Probably effective, ineffective, or harmful for the given condition in the specified population. (Level B rating requires at least one Class I study or at least two consistent Class II studies.)

• C: Possibly effective, ineffective, or harmful for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies.)

• U: Data inadequate or conflicting; given current knowledge, treatment is unproven.

• Class I. Prospective, randomized, controlled clinical trial (RCT) with masked outcome assessment, in a representative population

• Class II. Prospective matched group cohort study in a representative population with masked outcome assessment that meets A–D above OR a RCT in a representative population that lacks one criterion A–D.

• Class III. All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement.

• Class IV. Evidence from uncontrolled studies, case series, case reports, or expert opinion. The report included the following conclusions and recommendations.

• Epidural steroid injections may result in some improvement in radicular lumbosacral pain when determined between 2 and 6 weeks following the injection, compared to control treatment (Level C, Class I–III evidence). The average magnitude of effect is small, and the generalizability of the observation is limited by the small number of studies, limited to highly selected patient populations, the few techniques and doses studied, and variable comparison treatments.

• In general, epidural steroid injections for radicular lumbosacral pain have shown no impact on average impairment of function, on need for surgery, or on long-term pain relief beyond 3 months. Their routine use for these indications is not recommended (Level B, Class I–III evidence).

• Data on use of epidural steroid injections to treat cervical radicular pain are inadequate to make any recommendation (Level U).

A North American Spine Society (NASS) Clinical Guideline for Multidisciplinary Spine Care, Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis, updated in 2011, includes recommendations for epidural steroid injections. Recommendations are rated as follows:

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• A: Good evidence (Level I studies with consistent findings) for or against recommending intervention. • B: Fair evidence (Level II or III studies with consistent findings) for or against recommending

intervention. • C: Poor quality evidence (Level IV or V studies) for or against recommending intervention. • I: Insufficient or conflicting evidence not allowing a recommendation for or against intervention.

The guideline includes the following recommendations:

• Contrast-enhanced fluoroscopy is recommended to guide epidural steroid injections to improve the accuracy of medication delivery. Grade of recommendation: A

• Interlaminar epidural steroid injections are suggested to provide short-term (two weeks to six months) symptom relief in patients with neurogenic claudication or radiculopathy. There is, however, conflicting evidence concerning long-term (21.5-24 months) efficacy. Grade of recommendation: B

• A multiple injection regimen of radiographically-guided transforaminal epidural steroid injection or caudal injections is suggested to produce medium-term (3-36 months) relief of pain in patients with radiculopathy or neurogenic intermittent claudication (NIC) from lumbar spinal stenosis. Grade of recommendation: C

The authors noted that the “multiple-injection” regimen utilized in newer studies should be distinguished from a “series” of injections used in older studies. In a multiple-injection protocol, a patient is a candidate for a repeat injection when pain recurs or becomes severe again. The purpose of this protocol is to control pain over a longer period of time to maximize the chance that the patient will respond to medical/interventional therapy. A series of injections generally consists of three injections performed at 24-hour or one week intervals regardless of symptoms. A North American Spine Society (NASS) Clinical Guideline for Multidisciplinary Spine Care, Diagnosis and Treatment of Cervical Radiculopathy (2010) includes the following recommendation for epidural steroid injections:

• Transforaminal epidural steroid injections using fluoroscopic or CT guidance may be considered when developing a medical-interventional treatment plan for patients with cervical radiculopathy from degenerative disorders. Due consideration should be given to potential complications. Grade of recommendation: C

Intradiscal steroid injections, in which glucocorticoids are injected directly into the intervertebral disc under fluoroscopy, has been proposed as a method to reduce the degree of disc herniation and/or produce an inflammatory response. According to The ACOEM evidence-based practice guidelines on low back disorders (2011) intradiscal steroid injections are not recommended for the management of acute low back pain. The available evidence indicates that intradiscal steroid injections are not effective. There is no quality evidence that these injections improve on the natural history of the condition, or that they provide a treatment benefit compared to no treatment or treatment with epidural steroids. In addition, these injections may cause discitis, progression of disc degeneration, and calcification of the intervertebral disc. The guideline also states that intradiscal steroids are moderately not recommended for subacute or chronic low back pain. There is insufficient evidence in the published medical literature to determine the safety and efficacy of Intradiscal steroid injection for the treatment of back pain. Facet joint injections/facet blocks (e.g., medial branch blocks) have been used to treat back pain and/or to help determine whether the facet joint is a source of pain. Facet joints (i.e., zygapophysial joints) are located in the posterior compartment of the spinal column, and provide stability and allow the spine to bend and twist. Facet joints are well innervated by the medial branches of the dorsal rami, and can be subjected to significant strain during spine loading. Facet joints are thought to be a common source of chronic back pain. A diagnostic facet joint injection involves fluoroscopy-guided injection of local anesthetic with or without a steroid into the facet joint or around the nerve supply to the joint (i.e., medial branch nerve). A diagnostic facet joint

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injection may be used to identify the source of spinal pain. If pain is relieved following the injection, the pain is presumed to be of facet joint origin, although the accuracy of this diagnostic method has not been definitely determined. Therapeutic facet joint injections of an anesthetic and corticosteroid have been proposed as treatment of pain considered to be of facet joint origin (i.e., significant relief following a diagnostic injection). The Canadian Agency for Drugs and Technology in Health (CADTH) rapid response report, Facet Joint Injection as Diagnostic and Therapeutic Tools for Pain of the Cervical and Lumbar Spine: A Review of Clinical and Cost-Effectiveness, was published in 2011. The report was based on evaluation of six systematic reviews, one randomized controlled trial, and five non-randomized studies. The clinical efficacy of diagnostic cervical and lumbar diagnostic facet joint injections was unclear. Some evidence suggests that false positive rates are approximately 30-60%, which could limit the clinical utility of diagnostic injections. There was some evidence of short-term benefit of therapeutic lumbar facet joint injections for relief of low back pain, but evidence of longer-term benefit was unclear. The majority of evidence was based on patients who failed to respond to conventional treatment, and generalizability to the broader population with lumbar facet joint pain is unknown. The literature does not support the use of therapeutic cervical facet joint injections for neck pain. The report concluded that overall, evidence of the diagnostic accuracy and clinical effectiveness of lumbar and cervical facet joint injections is conflicting and subject to a number of limitations. Therefore, the diagnostic accuracy and clinical effectiveness of lumber and cervical facet joint injections remains largely unknown. The results of the Cochrane systematic review of the effects of injection therapy involving epidural, facet or local sites, discussed above (Staal, et al. 2008), indicated that there was no strong evidence for or against the use of any type of injection therapy. The authors concluded that there is insufficient evidence to support the use of injection therapy in subacute and chronic low back pain, but it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy. The ASIPP guideline referenced above (Manchicanti, et al., 2013) includes the following recommendations: Low back pain

• Diagnostic: The evidence for diagnostic lumbar facet joint nerve blocks is good with 75% to 100% pain relief

as the criterion standard with controlled local anesthetic or placebo blocks. Diagnostic lumbar facet joint nerve blocks are recommended in patients with suspected facet

joint pain. • Therapeutic

The evidence is fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections.

Among the therapeutic facet joint interventions either conventional radiofrequency neurotomy or therapeutic facet joint nerve blocks are recommended after the appropriate diagnosis with controlled diagnostic lumbar facet joint blocks.

Neck pain

• Diagnostic The evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of

75% or greater relief with placebo or local anesthetic controlled diagnostic blocks. Diagnostic cervical facet joint nerve blocks are recommended for the diagnosis of cervical facet

joint pain. • Therapeutic

The evidence is fair for cervical medial branch blocks, and limited for cervical intraarticular injections

Therapeutic facet joint nerve blocks are recommended in managing chronic neck pain after the appropriate diagnosis from controlled diagnostic blocks.

Thoracic pain

• Diagnostic The evidence for diagnostic accuracy of thoracic facet joint nerve blocks is good with a criterion

standard of at least 75% pain relief with placebo or local anesthetic controlled diagnostic blocks.

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The diagnostic thoracic facet or zygapophysial joint nerve blocks are recommended in the diagnosis of chronic thoracic pain.

• Therapeutic The evidence is fair for therapeutic thoracic facet or zygapophysial joint nerve blocks, limited for

radiofrequency neurotomy, and none for thoracic intraarticular injections Therapeutic thoracic facet or zygapophysial joint nerve blocks are recommended. However,

radiofrequency neurotomy and conventional radiofrequency neurotomy may be performed based on emerging evidence.

The ASA Task Force on Chronic Pain Management/ASRA and Pain Medicine guideline on chronic pain management states that diagnostic medial branch blocks or facet joint injections may be considered for patients with suspected facet-mediated pain to screen for subsequent therapeutic procedures, and that intra-articular facet joint injections may be used for the symptomatic relief of facet mediated pain. The guideline also states that Intra-articular facet injections may be used for the symptomatic relief off facet-mediated pain. As stated above, the guideline was based on scientific evidence, opinion-based evidence (i.e., expert opinion, membership opinion, and informed opinion). The level of evidence for individual recommendations is not specified. The ACOEM evidence-based practice guidelines on low back disorders (2011) states that one diagnostic facet joint injection may be recommended for patients with chronic low back pain that is significantly exacerbated by extension and rotation or associated with lumbar rigidity, and is not alleviated with other conservative treatments e.g., NSAID, progressive aerobic exercises, other exercises, and manipulation). This diagnostic injection may determine whether specific interventions targeting the facet joint are recommended. Repeated diagnostic injections in the same location are not recommended. The guideline states that therapeutic facet joint injections are not recommended for acute, subacute, or chronic low back pain or for any radicular pain syndrome. The guideline also states that there is no recommendation for or against the use of therapeutic facet joint injections for treatment of flare ups of chronic low back pain, and that therapeutic facet joint injections are moderately not recommended for routine treatment of chronic non-specific axial pain. Repeat use of intra-articular therapeutic facet joint injections are moderately not recommended for patients who have failed to achieve lasting functional improvements with a prior injection. The AANS guideline on injection therapies, low-back pain, and lumbar fusion (referenced above) concluded that there is evidence that suggests that facet joint injections can be used to predict outcome of radiofrequency ablation of a facet joint. No evidence exists, however, to support the effectiveness of facet injections in the treatment of patients with chronic low-back pain. SI joint injection of anesthetic and steroid, performed under fluoroscopic guidance, has been proposed as a method to confirm that pain originates from the SI joint. The SI joint lies between the sacrum and the ileum, and functions more for stability than for movement. The joint’s stability is maintained in part by several large ligaments and muscle groups. Pain may arise in this highly innervated joint or in the related muscles and ligaments. Pain may be felt in the lower back or may radiate to one or both hips and/or one or both legs. If the injection does not alleviate the pain, alternative diagnoses may be considered (ECRI, 2008). The ASIPP guidelines referenced above (Manchicanti, et al., 2013, include the following conclusions: Diagnostic:

• The evidence for diagnostic intraarticular sacroiliac joint injections is good with 75% to 100% pain relief as the criterion standard with controlled local anesthetic or placebo blocks, and fair due to the limitation of the number of studies with 50% to 74% relief with a dual block.

• Controlled sacroiliac joint blocks with placebo or controlled comparative local anesthetic blocks are recommended when indications are satisfied with suspicion of sacroiliac joint pain

Therapeutic • The evidence is limited for sacroiliac intraarticular steroid injections; and limited for periarticular

injections with steroids or botulinum toxin • Due to emerging evidence for intraarticular injections, they are recommended in select cases with or

without periarticular injections. Cooled radiofrequency neurotomy is recommended after appropriate diagnosis confirmed by diagnostic sacroiliac joint injections.

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The ACOEM evidence-based practice guidelines on low back disorders (2011) state that SI joint injections are not recommended for acute low back pain, including low back pain thought to be SI joint related, or for subacute or chronic non-specific low back pain, including pain attributed to the SI joint, but without evidence of inflammatory sacroiliitis. The guideline also states that SI joint injections are not recommended for treatment of any radicular pain syndromes, and recommends SI joint injections as a treatment option only for patients with a specific known cause of sacroiliitis (i.e., proven rheumatologic inflammatory arthritis involving the SI joint). The ASA Task Force on Chronic Pain Management /ASRA and Pain Medicine guideline on chronic pain management states that diagnostic SI joint injections or lateral branch blocks may be considered for the evaluation of patients with suspected SI joint pain, and that SI joint injection may be considered for the symptomatic relief of sacroiliac joint pain. American Pain Society: The following recommendations are included in an evidence-based clinical practice guideline from the American Pain Society, Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain (Chou et al., 2009):

• There is insufficient evidence to evaluate the validity or utility of diagnostic selective nerve root block, intra-articular facet joint block, medial branch block, or sacroiliac joint block as diagnostic procedures for low back pain with or without radiculopathy.

• In patients with persistent nonradicular low back pain, facet joint corticosteroid injection, and intradiscal corticosteroid injection are not recommended

• There is insufficient evidence to adequately evaluate benefits of local injection, epidural steroid injection, therapeutic medial branch block, radiofrequency denervation, or sacroiliac joint steroid injection, for nonradicular low back pain.

• In patients with persistent radiculopathy due to herniated lumbar disc, it is recommended that clinicians discuss risks and benefits of epidural steroid injection as an option. It is recommended that shared decision-making regarding epidural steroid injection include a specific discussion about inconsistent evidence showing moderate short-term benefits, and lack of long-term benefits.

• There is insufficient evidence to adequately evaluate benefits and harms of epidural steroid injection for spinal stenosis.

The authors recommend consideration of interdisciplinary rehabilitation with a cognitive/behavioral emphasis as a treatment option in patients with nonradicular low back pain who do not respond to usual, non-interdisciplinary interventions. Guidance for Injections Guidance is not needed for trigger point injections, since the injection is made into skeletal muscle tissue. The use of fluoroscopy for diagnostic and therapeutic epidural injections is recommended, however, for several reasons. Injections performed without fluoroscopic guidance are not always made into the epidural space or the intended interspace. Needle misplacement has been estimated to occur in 40% of caudal and 30% of lumbar epidural injections when done without fluoroscopic guidance. Accidental intravascular injections may also occur. In addition, if anatomical anomalies, such as a midline epidural septum or multiple separate epidural compartments are present, flow of medication to the presumed pain generator is restricted and remains undetected without fluoroscopy. Finally, if an injection fails to relieve pain, it would not be possible to determine whether the failure was caused by a poor response or by improper needle placement (Canale and Beaty, 2012). Ultrasound (US) guidance has been proposed as an alternative to fluoroscopic guidance. A randomized controlled trial by Park et al (2013) compared the short-term effects and advantages of ultrasound-guided caudal epidural steroid injections with fluoroscopy guided injections for lumbar radicular pain (n=120)..There was no significant difference in treatment effects between the groups at two weeks and twelve weeks. US has also been proposed as an alternative to fluoroscopy or CT guidance for facet injections. Facet joint injections are typically performed using fluoroscopic guidance in order to identify the target facet joint and surrounding structures and to ensure accurate needle placement. A randomized controlled trial by Obernauer et al. (2012) evaluated the accuracy, time-saving, radiation doses and pain relief of ultrasound guided facet joint injections compared to CT guided injections. The accuracy of ultrasound-guided interventions was 100%.The mean time to final needle placement was significantly shorter in the US group compared to the CT group

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(p<0.05) The mean radiation dose, including CT confirmation for study purposes only, was significantly shorter in the US group vs. .the CT group (p<0.05). Both groups showed the same significant improvement in VAS scores. Follow-up was limited to 30 days post-procedure. There are no published studies in the medical literature that compare the use of ultrasound guidance for epidural steroid, facet joint, or sacroiliac joint injections, compared to the current standard, fluoroscopic guidance. There is insufficient evidence in the published medial literature to demonstrate the safety, efficacy, and long-term outcomes of ultrasound guidance for injection therapy. Choosing Wisely: The following statement is included in the North American Spine Society Choosing Wisely recommendations: Elective spinal injections, such as epidural steroid injections, should be performed under imaging guidance using fluoroscopy or CT with contrast enhancement (unless contraindicated) to ensure correct placement of the needle and to maximize diagnostic accuracy and therapeutic efficacy. Failure to use appropriate imaging may result in inappropriate placement of the medication, thereby decreasing the efficacy of the procedure and increasing the need for additional care. Summary– Injection Therapies The evidence for the use of diagnostic and therapeutic injections in the treatment of acute, subacute and chronic back pain is limited. Based on the available evidence and specialty society recommendations and guidelines, trigger point injections may be appropriate for selected patients with persistent chronic back, neck or myofascial pain despite appropriate conservative treatment. Epidural steroid injections may be considered in the treatment of selected patients with radicular pain as part of an active therapy program. These injections may provide short-term improvement and allow a determination as to whether conservative treatment will be successful. There is insufficient evidence, however, to demonstrate that epidural steroid injections are effective in the treatment of back pain in the absence of radicular symptoms. A diagnostic facet joint injection may be indicated for patients with low back pain that is significantly exacerbated by extension and rotation and not improved with conservative treatment. A diagnostic facet joint injection may assist in determining whether specific interventions targeting the facet joint are indicated. There is insufficient evidence to demonstrate that therapeutic facet joint injections are effective in the treatment of back pain, however. SI joint injection may be considered as a treatment option for patients with localized SI joint pathology (e.g., inflammatory arthritis) that has been confirmed on imaging studies. There is insufficient evidence, however, to demonstrate that SI injections are effective in the diagnosis of treatment of back pain or radicular syndromes. The performance of any combination of injection therapies (epidural steroid injections/sympathetic nerve blocks, facet joint injections, sacroiliac joint injections) on the same day is not recommended. If the initial procedure does not produce improvement within a reasonable period of time and the presumed diagnosis is considered to be excluded, it may be reasonable to proceed to the next logical treatment. Ablative Treatments Percutaneous Radiofrequency Denervation/Radiofrequency Neurotomy/Facet Rhizotomy/Rhizolysis Percutaneous radiofrequency denervation is referred to by numerous terms, including radiofrequency ablation (RFA), radiofrequency neurotomy, radiofrequency facet rhizotomy, and radiofrequency articular rhizolysis. Radiofrequency denervation was introduced as a treatment modality for patients with a variety of chronic spinal pain syndromes, including facet joint pain syndrome. This pain-reduction technique may be considered for patients with back pain that is unresponsive to conservative therapy and for which there is no clear indication for surgery. Radiofrequency denervation may target areas adjacent to the dorsal root ganglion (DRG) and the medial branches. The dorsal and ventral roots of the 31 pairs of spinal nerves are attached to each segment of the spinal cord. Each spinal nerve attaches to the spinal cord by a dorsal (sensory) and a ventral (motor) root. The DRG is found on the posterior root of each spinal nerve and is composed of the nerve cell bodies of the sensory neurons of the nerve. Both somatic and visceral afferent fibers from potential nocioceptors (pain receptors) in the spine have cell bodies in the DRG, indicating that the DRG conducts pain impulses inward to the spinal cord and brain from the peripheral parts of the body. The medial branch (ramus medialis, or internal branch) is a small nerve that arises from the dorsal ramus that in turn branches from the spinal cord. This nerve innervates

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the joint facet and carries nocioceptive signals from the spine to the brain. It is, in addition to the DRG, a main target for denervation may target areas adjacent to the dorsal root ganglion (DRG) and the medial branches treatment of spinal pain. During RFA, an electrode introduced through the skin is used to deliver heat produced by radio waves in order to destroy the sympathetic nerve supply of the painful spinal structure. In most cases, diagnostic nerve blocks are undertaken prior to denervation, and only chronic back pain patients with a positive temporary response to the diagnostic blocks proceed to denervation may target areas adjacent to the dorsal root ganglion (DRG) and the medial branches. Several alternatives to percutaneous radiofrequency denervation have been proposed, including pulsed radiofrequency (discussed below), cryoneurolysis, laser ablation, and chemical ablation, in which a neurolytic substance (e.g., alcohol, phenol, glycerol) is injected into the affected nerve root. An alternative method of denervation using an endoscopic approach (i.e., endoscopic dorsal ramus rhizotomy) has also been proposed. There is insufficient evidence in the published medical literature to determine the safety and efficacy of these emerging alternative modalities or approaches compared to radiofrequency denervation for the treatment of spinal pain. Smuck et al. (2012) conducted a systematic review to evaluate the duration of pain relief after initial and repeated radiofrequency neurotomy (RFN) for cervical and lumbar zygapophysial joint pain. The review included 16 studies; eight cervical studies, seven lumbar studies, and one study of both cervical and lumbar treatment. The methodology and design quality of the cervical studies generally exceeded that of the lumbar studies. For initial cervical, RFN, the average duration of more than 50% pain relief was 7.3-8.6 months. When the initial RFN procedure was successful, repeat RFN was successful 67-95% of the time. When the initial treatment was unsuccessful, repeat treatment was successful 0-67% of the time. The average duration of pain relief after repeat RFN was 6.0-12.7 months. For initial lumbar RFN, the average duration of more than 50% pain relief was 9.0 months. Repeat lumbar RFN was successful 33-85% of the time. Repeat treatment was successful 33-85% of the time when the first RFN procedure was successful, with an average duration of pain relief of 11.6 months after successful repeat RFN. Prushansky et al. (2006) evaluated radiofrequency neurotomy in a series of 40 patients with chronic whiplash injury-associated disorders. According to the authors, prior studies have focused solely on pain and psychological distress factors. The purpose of the study was to extend the assessment of the procedure’s efficacy by adding other outcome measures. Patients were evaluated prior to and at two separate sessions following radiofrequency treatment. The evaluations included the Neck Disability Index, cervical range of motion, isometric cervical muscle strength, cervical pressure pain threshold, Symptom Check List-90 Revised, and subjective Self Report of Improvement (SRI). The authors reported that cervical radiofrequency neurotomy had a significantly positive effect on all measured parameters. Using strict cutoff values taking improvement followed by regression into account, between 30% and 60% of patients experienced measurable improvement. Evaluation of SRI results indicated that 80% of patients were satisfied with the procedure. van Wijk et al. (2005) conducted a randomized, double-blind sham lesion-controlled trial to determine the efficacy of radiofrequency facet joint denervation as it is routinely performed. The study was designed to reflect common practice in that, although no interventions between trial treatment and three months’ follow-up were performed, further radiofrequency or injection procedures were allowed after this period if the initial treatment did not sufficiently alleviate pain. Patients were randomized to radiofrequency (n=40) or a sham treatment (n=41). The primary outcome was determined with a combined outcome measure comprised of VAS, physical activities and analgesic intake. Secondary outcome measures were the separate diary parameters, global perceived effect (i.e., complete relief, > 50% relief, no effect) of pain increase, and SF-36 Quality of Life Questionnaire. There was no difference between the two groups in the combined outcome measure or VAS, although both groups showed improvement in VAS scores. The global perceived effect, however, improved in the radiofrequency group. The researchers observed that the lack of improvement in physical function despite reduction pain scores underlines the need to combine these procedures with subsequent structured rehabilitation programs. The authors concluded that in selected patients, radiofrequency facet denervation appears to be more effective than sham treatment. A Cochrane systematic review (Niemisto et al., 2002, updated 2005) evaluated randomized controlled trials of radiofrequency denervation for musculoskeletal pain disorders and concluded that there is limited evidence that radiofrequency denervation offers short-term relief for chronic neck pain of zygapophyseal joint origin and for chronic cervicobrachial pain. The authors reported conflicting evidence on the short-term effect of denervation

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on pain and disability in patients with low back pain of zygapophyseal joint origin and that there is a need for further randomized controlled trials with larger patient samples and data on long-term outcomes. The ACOEM evidence-based practice guidelines on low back disorders (2011) state that, due to insufficient evidence, there is no recommendation for or against the use of radiofrequency neurotomy, neurotomy, or facet rhizotomy for treatment of patients with chronic low back confirmed with diagnostic blocks, but who do not have radiculopathy and who have failed conservative treatment. Radiofrequency neurotomy, neurotomy, and facet rhizotomy are not recommended for treatment of all other lumbar spinal conditions. The American Society of Interventional Pain Physicians (ASIPP) practice guideline, Interventional Techniques in the Management of Chronic Spinal Pain (Manchicanti, et al., 2013), includes the following recommendations:

• The evidence for lumbar conventional radiofrequency neurotomy is good, • Among the therapeutic facet joint interventions either conventional radiofrequency neurotomy or

therapeutic facet joint nerve blocks are recommended after the appropriate diagnosis with controlled diagnostic lumbar facet joint blocks.

• The evidence conventional cervical radiofrequency neurotomy is fair, and is limited for thoracic radiofrequency neurotomy

The guideline suggests a frequency for medial branch neurotomy of six months or longer, with a maximum of two times per year, provided that > 50% relief is obtained for 10–12 weeks. It is suggested that all regions be treated at the same time, provided all procedures can be performed safely. ASA Task Force on Chronic Pain Management and the American Society of Regional Anesthesia (ASRA) and Pain Medicine (2010) states that other treatment modalities should be attempted before the consideration of ablative techniques, and includes the following recommendations:

• Conventional (e.g., 80°C) or thermal (e.g., 67°C) radiofrequency ablation of the medial branch nerves to the facet joint should be performed for low back (medial branch) pain when previous diagnostic or therapeutic injections of the joint or medial branch nerve have provided temporary relief.

• Conventional radiofrequency ablation may be performed for neck pain.

• Water-cooled radiofrequency ablation may be used for chronic sacroiliac joint pain.

• Chemical denervation (e.g., alcohol, phenol, or high concentration local anesthetics) should not be used in the routine care of patients with chronic noncancer pain.

• Cryoablation may be used in the care of selected patients (e.g., postthoracotomy pain syndrome, low back pain [medial branch], and peripheral nerve pain).

• Conventional or other thermal radiofrequency ablation of the dorsal root ganglion should not be routinely used for the treatment of lumbar radicular pain.

The guideline was based on scientific evidence, opinion-based evidence (i.e., expert opinion, membership opinion, and informed opinion). The level of evidence for individual recommendations is not specified. Several alternatives to percutaneous radiofrequency denervation have been proposed, including pulsed radiofrequency (discussed below), cooled radiofrequency, cryoneurolysis, laser ablation, and chemical ablation, in which a neurolytic substance (e.g., alcohol, phenol, glycerol) is injected into the affected nerve root. An alternative method of denervation using an endoscopic approach (i.e., endoscopic dorsal ramus rhizotomy) has also been proposed. There is insufficient evidence in the published medical literature to determine the safety and efficacy of these emerging alternative modalities or approaches compared to radiofrequency denervation for the treatment of spinal pain. Sacroiliac (SI) Joint Radiofrequency Denervation/Radiofrequency Ablation (RFA)/Radiofrequency Neurotomy: As discussed above. radiofrequency denervation of facet joints has been used to treat spinal pain presumed to be of facet origin. Thermal/conventional RFA as well as cooled radiofrequency have also been explored for the treatment of SI joint pain. The sensory innervation of the SI joint has not been defined as

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definitively as that of the lumbar facet joints, however. Most of the posterior sensory innervation is thought to be transmitted from the S1, S2, and S3 dorsal rami via the lateral branches, as well as though medial branches from the L4 and L5 dorsal rami (Ayden, 2010). Evaluation of radiofrequency neurotomy was included in systematic review of the therapeutic effectiveness of SI joint interventions (Hansen et al., 2012). The authors concluded that the evidence was fair for cooled radiofrequency neurotomy. Limitations of the review included a paucity of literature on therapeutic interventions, variations in technique, and variable diagnostic standards for SI joint pain. Aydin et al. (2010) conducted a meta-analysis to assess the effectiveness of RFA of the SI joint for pain relief at three and six months. Ten articles were included in the analysis. Different techniques and combinations of different nerve lesions were used in the included studies. The authors noted that no standards have been established for the specific nerves to ablate, the type of technique, or the type of RFA. The primary outcome measure was a reduction in pain by ≥ 50%. Analysis was conducted on seven groups from six studies. At three and six month follow-up, half or greater of the patients treated with RFA of the SI joint met the outcome measure of ≥ 50%.reduction in pain. The authors concluded that RFA of the SI joint appears to have a role in the treatment of patients with SI joint pain refractory to more conservative measures. The study is limited, however, by the available literature and lack of randomized controlled trials. Evaluation of radiofrequency neurotomy was included in a systematic review of the therapeutic effectiveness of SI joint interventions (Hansen et al., 2012). Limitations of the review included a paucity of literature on therapeutic interventions, variations in technique, and variable diagnostic standards for SI joint pain. The authors concluded that the evidence was poor for conventional and pulsed radiofrequency neurotomy. According to the ASIPP practice guidelines referenced above (Manchicanti, et al., 2013), the evidence is limited for sacroiliac conventional radiofrequency neurotomy. There is insufficient evidence in the published medical literature to demonstrate the safety and efficacy of SI joint radiofrequency ablation (RFA) or ablation of lumbar or sacral dorsal rami for the treatment of SI joint pain. Pulsed Radiofrequency Pulsed radiofrequency has been introduced as a nonablative alternative to RFA. Pulsed radiofrequency delivers short bursts of radiofrequency current rather than the continuous flow utilized in standard RFA. Pulsed radiofrequency allows the tissue to cool between bursts, resulting in lower maximum temperatures compared to continuous radiofrequency. This technique is reported to reduce the risk of destruction of neighboring tissue. It does not destroy targeted nerves and therefore requires less precise electrode placement. The mechanism of action of pulsed radiofrequency is not well understood. It has been hypothesized that electrical fields reversibly disrupt the transmission of nerve impulses across small unmyelinated fibers, but the fibers are not destroyed, and larger fibers are not affected Studies of pulsed radiofrequency consist primarily of small trials with limited follow-up. Most studies are case series in which the safety and efficacy of pulsed radiofrequency cannot be evaluated against alternative treatment methods (Vallejo et al., 2006; Lindner et al., 2006; Martin et al., 2007). Van Zundert et al. (2007) conducted a randomized sham-controlled trial evaluating pulsed radiofrequency for the treatment of chronic cervical radicular pain. Of 256 patients screened, 23 met the inclusion criteria. Patients were eligible if they reported neck pain radiating over the posterior shoulder to the arm persisting for > six months, had symptoms suggestive of cervical spinal nerve involvement, and were unresponsive to conventional therapy. The primary outcome was comprised of three measures three months after the intervention: success defined as at least 50% pain improvement of the global perceived effect (GPE); a reduction of at least 20% in the VAS pain score; and reduced pain medication intake. An improvement of the GPE of at least 50% was achieved in 9/11 (82%) patients in the radiofrequency group and 4/12 (33%) in the sham group (p=0.03). A reduction of at least 20% in the VAS pain score was seen in 9/11 patients in the radiofrequency group (82%) compared to 3/12 (25%) in the sham group (p=0.02). A reduction in pain medication intake was noted in the radiofrequency group, but no significance was reached at three months. The need for pain medication was significantly reduced in the pulsed radiofrequency group after six months, however. The authors concluded that pulsed radiofrequency treatment of the cervical dorsal root ganglion may provide pain relief for a limited number of carefully selected patients. The authors stated that, since percutaneous pulsed radiofrequency is presumed to

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be less neurodestructive, this approach may have a better risk/benefit ratio than continuous radiofrequency lesioning, but this hypothesis needs to be confirmed in larger observational studies. Tekin et al. (2007) conducted a randomized, controlled double-blind trial to compare conventional and pulsed radiofrequency denervation for treatment of chronic facet joint pain. Patients over age 17, with symptoms of greater than six months duration, were randomized to treatment with continuous radiofrequency (n=20), treatment with pulsed radiofrequency (n=20), or to a control group (n=20). Patients in the control group received local anesthetic alone. Radiofrequency treatment was subsequently made available to patients in the control group who experienced no pain relief. Pain relief was evaluated using a VAS and Oswestry Disability Scale (ODI) prior to the procedure, at the time of the procedure, and six and twelve months post-procedure. Pre-procedure VAS and ODI scores were similar in all groups. Mean pre-procedure VAS and ODI scores were higher than all post-procedure scores in all groups. Mean VAS and ODI scores were lower in both radiofrequency groups than in the control group at the post-procedure evaluation. The decrease in pain was maintained in the continuous radiofrequency group at six months and one year but was not maintained in the pulsed radiofrequency group. Analgesic usage was lower and patient satisfaction was higher in the continuous radiofrequency group. The 2013 ASIPP practice guideline, Interventional Techniques in the Management of Chronic Spinal Pain, states that the evidence is limited for lumbar pulsed radiofrequency. There is insufficient evidence in the published medical literature to demonstrate the safety and efficacy of pulsed radiofrequency in the treatment of spinal pain. Studies published to date do not allow conclusions regarding the safety, efficacy, and duration of effect of this technique. Additional well-designed trials are needed to determine how this treatment compares to other medical and surgical treatments for chronic spinal pain. Percutaneous and Endoscopic Laminectomy and Disc Decompression Procedures Automated Percutaneous Lumbar Discectomy (APLD)/Automated Percutaneous Nucleotomy: Automated percutaneous lumbar discectomy (APLD), also referred to as automated percutaneous nucleotomy, is a minimally-invasive surgical procedure used in the treatment of herniated lumbar intervertebral discs. In this procedure, a cannula is placed in the center of the disc under fluoroscopic guidance using a posterolateral approach. A probe connected to an automated cutting and aspiration device is then introduced through the cannula. The disc is then aspirated until no more nuclear material is obtained (NICE, 2004) A systematic review by Manchikanti et al. (2013) evaluated the use of automated percutaneous mechanical lumbar discectomy for treatment of contained herniated lumbar discs. The primary outcome was pain relief; secondary outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Nineteen observation studies were included; of the three randomized trials reviewed, none met inclusion criteria for methodological quality assessment. The authors stated that, due to the lack of randomized trials. The evidence is limited for automated percutaneous mechanical lumbar discectomy, but the procedure may provide appropriate relief in properly selected patients with contained lumbar disc herniation. Manchikanti et al. (2013) conducted a systematic review to evaluate the evidence for percutaneous disc decompression (PDD) with Dekompressor in the management of chronic low back and lower extremity pain. The primary outcome was pain relief; secondary outcome measures included functional improvement, improvement of psychological status, opioid intake, and return to work. The authors stated that the evidence of effectiveness is limited, but the procedure may be recommended for patients with persistent pain after failure of other intervention techniques when microdiscectomy is not indicated. Hirsch et al. (2009) conducted a systematic evaluation of the literature to determine the effectiveness of APLD. The primary outcome measure was pain relief; short term effectiveness was defined as significant (>50%) pain relief at six months, and long term effectiveness was defined as significant pain relief at one year. Other outcome measures included functional improvement, improvement in psychological status, and return to work. The authors concluded that this systematic review indicates Level II-2 evidence for APLD; APLD may provide appropriate relief in properly selected patients with contained lumbar disc prolapse. (Level II-2 evidence, as defined by the U.S. Preventive Services Task Force as evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.). The authors acknowledged the paucity of randomized controlled trials in the literature as a limitation.

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A Cochrane review of surgery for lumbar disc prolapse, published in 2003 and updated in 2007 (Gibson and Waddell), assessed the effects of available surgical interventions and states that trials of APLD suggest that clinical outcomes are at best fair and certainly worse than microdiscectomy, although the importance of patient selection is acknowledged. The authors stated that there is a need for high-quality randomized controlled trials on APLD and for long-term studies into the effects of surgery on the lifetime natural history of disc disease. The Cochrane review concluded that unless or until better scientific evidence is available, APLD should be regarded as a research technique. An ECRI Health Technology Assessment on automated percutaneous nucleotomy (ECRI, 2004) concluded that the available evidence does not favor the use of automated percutaneous nucleotomy over microdiscectomy for treatment of patients with symptomatic herniated lumbar discs. The procedure leads to inferior combined pain and function scores compared to microdiscectomy, and it is more likely to fail, requiring additional surgery. The strength of evidence supporting these conclusions is weak, however due to the low number of studies and small number of patients. ASIPP 2013 Practice Guidelines for the Management of Chronic Spinal Pain, state that the evidence is limited to fair for APLD, and that the procedure is recommended in select cases. American College of Occupational and Environmental Medicine (ACOEM) evidence-based practice guidelines on low back disorders, surgical considerations (2011) states that there is no quality evidence that automated percutaneous discectomy is an effective treatment for any back or radicular pain problem. There is insufficient evidence in the peer-reviewed medical literature to support the safety and efficacy of APLD. Results of published studies are inconsistent and do not demonstrate long-term improvement. There is no evidence that APLD is as effective as discectomy/microdiscectomy. Laser Discectomy (Percutaneous or Laparoscopic)/, Laser Disc Decompression/Laser Assisted Disc Decompression (LADD): Laser-assisted discectomy, also called laser-assisted disc decompression (LADD) or laser disc decompression, is a minimally-invasive procedure proposed as an alternative to discectomy/microdiscectomy. It is intended to provide symptomatic relief of pain cause by a contained herniated intervertebral disc. Laser light energy is used to vaporize part of the nucleus pulposus, resulting in a reduction in intradiscal pressure. Several approaches may be used, depending on the location of the disc and type of laser being used. With one method, a needle is inserted percutaneously into the disc approximately one centimeter (cm) posterior to the disc center, and a flexible optical quartz fiber is threaded through the needle into the disc, delivering laser energy to vaporize and coagulate the nucleus pulposus. In the laparoscopic approach, a trocar is inserted periumbilically and the abdomen is inflated with carbon dioxide. Additional trocars are placed above the pelvic brim. The large and small bowels are retracted, and the iliac bifurcation is identified. The posterior peritoneum is opened and retracted. The L5-S1 interspace is identified and its margins confirmed by x-ray. The annulus of the disc is opened and excised with the neodymium: yttrium-aluminum-garnet (Nd: YAG) laser. A review of the literature published by Schenck et al. (2006) evaluated 16 clinical trials representing a total of 1579 patients. Most were case series with small sample sizes, making interpretation of success rates difficult. Generalization of the results into general clinical practice remains difficult due to different inclusion and exclusion criteria, laser types, and outcome measures as well as the variation in duration of follow-up. These shortcomings prevent a valid comparison to studies evaluating the outcome of conventional surgical treatment for lumbar disc herniation. The authors concluded that well-designed research of sufficient scientific strength comparing percutaneous laser disc decompression to both conventional surgery and conservative management is needed to determine whether this procedure has a role in the treatment of lumbar disc herniation. An ECRI Health Technology Assessment (2004) evaluating laser discectomy for the treatment of herniated lumbar discs noted a lack of controlled trials comparing this procedure to either continued conservative care or other operative procedures such as open discectomy or microdiscectomy. Since laser discectomy is considered an alternative to open discectomy, the absence of a trial comparing these procedures is noteworthy. The authors stated that controlled trials are important when evaluating pain-relieving treatments to determine the influence of nonspecific effects and regression to the mean on pain-related outcome measures. Considering the natural history of herniated lumbar discs, pain relief may be as likely without invasive treatment as with invasive

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treatment. A controlled trial is needed to determine the actual extent to which laser discectomy achieves pain relief beyond the natural course of the disorder. An ECRI Health Technology Assessment (2009) evaluating percutaneous disc decompression for cervical disc herniation focused on techniques that remove or ablate the nucleus pulposus, including APLD, percutaneous laser discectomy, and plasma disc decompression (PDD), also referred to as nucleoplasty. The report states that one low-quality small study and one moderate-quality randomized controlled trial suggest that percutaneous decompression reduces pain more than conservative medical or physical therapy. Differences in reporting between the two studies and the poor reporting of one study prevent conclusive determination of whether this effect is statistically significant or clinically meaningful. The randomized trial suggested significantly improved quality of life and reduced disability with percutaneous discectomy, but results of a single study cannot be used to draw firm evidence-based conclusions. The authors noted that no evidence addressed the questions of how the efficacy of percutaneous cervical disc decompression compares with other surgical procedures or how efficacy outcomes compare among different methods of percutaneous disc decompression. A Cochrane systematic review of surgery for lumbar disc prolapse, published in 2003 and updated in 2007 (Gibson and Waddell), assessed the effects of available surgical interventions and states that trials of laser discectomy suggest that clinical outcomes are at best fair and certainly worse than microdiscectomy, although the importance of patient selection is acknowledged. The authors stated that there is a need for high-quality, randomized controlled trials on laser discectomy and for long-term studies into the effects of surgery on the lifetime natural history of disc disease. The Cochrane Review further concluded that unless or until further scientific evidence is available, laser discectomy should be regarded as a research technique. Updated ASIPP Practice Guidelines for the Management of Chronic Spinal Pain (2013) state that the evidence for percutaneous lumbar laser disc decompression is limited. ACOEM evidence-based practice guidelines on low back disorders, surgical considerations (2011) states that there is no quality evidence that laser discectomy is an effective treatment for any back or radicular pain problem. There is insufficient evidence in the published medical literature to demonstrate the safety, efficacy and long-term outcome of laser discectomy. There are no randomized controlled trials that evaluate laser discectomy and compare this procedure to established treatment methods. Endoscopic Anterior Spinal Surgery / Yeung Endoscopic Spinal Surgery (YESS) / Selective Endoscopic Discectomy: The Yeung Endoscopic Spinal System (Richard Wolf Surgical Instrument Corporation) is a specialized endoscope developed for percutaneous spinal endoscopy and discectomy. This endoscope has multi-channel inflow and outflow ports, allowing visualization through one port and suction or other therapeutic services through the working port. The YESS is also used for other spinal procedures, including arthroscopic microdiscectomy, radiofrequency ablation, injection of intraoperative steroids, and laser disc decompression and ablation. Selective Endoscopic Discectomy™ (SED), performed with the YESS endoscope, is used to shrink and remove herniated discs. Disc-FX™ System (Elliquence LLC, Baldwin, NY): The Disc-FX™ system is a single-use disposable kit used to perform minimally invasive lumbar disc procedures, including endoscopic disc decompression, nucleus ablation and annulus modulation.) There is a steep learning curve for procedures used to access and treat lesions with endoscopic guidance. The purported advantages of endoscopic discectomy or its superiority over microsurgical discectomy have not been demonstrated in the medical literature. There are no prospective controlled clinical trials of the YESS or the Disc FX system, nor are there any prospective studies with long-term follow-up. The efficacy of endoscopic spinal surgery and surgery with the YESS or Disc FX System has not been established in the peer-reviewed medical literature. The mild® Procedure: The mild® Device Kit (Vertos Medical, Inc., Aliso Viejo, CA) received U.S. Food and Drug Administration (FDA) approval on February 4, 2010. The device kit is set of specialized arthroscopic surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions. The mild device is used for image-guided minimally invasive lumbar decompression, referred

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to as the mild (minimally invasive lumbar decompression) procedure. The procedure is performed under fluoroscopic guidance through a dorsal approach to the spine. The instruments are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves. The mild® procedure has been proposed as a minimally invasive alternative to conservative treatment or surgical decompression for the treatment of lumbar spinal stenosis. Chopko (2013) reported two-year outcomes of mild lumbar decompression in the treatment of patients with neurogenic claudication associated lumbar spinal stenosis. The study included 45 of 58 patients included in an earlier analysis of one-year results Of the 13 patients unavailable at two years and not included in the two-year cohort, 3 underwent lumbar spine surgery, one died of unrelated causes, and nine did not respond or withdrew from the study. Outcome measures included the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). At two years, VAS improved from an average of 7.2 at baseline to a mean of 4.8 (p<0.0001); 79% reported an improvement in VAS scores and 29% reported lack of improvement or no improvement. Improvement in physical function and mobility was significant, as measured by the ZCQ and ODI. There were no major adverse events or device-related complications. Limitations of the study include lack of a control group or blinding, and significant numbers of patients lost to follow-up. Brown (2012) conducted a double-blind randomized study of epidural steroid injections (ESI) vs. the mild procedure in patients with symptomatic lumbar spinal stenosis (n=38). The included patients had painful lower limb neurogenic claudication, with hypertrophic ligamentum flavum as a contributing factor, and had failed conservative treatment. Patients were randomized to the mild procedure (n=21) or ESI (n=17). At six weeks, 76% of the patients in the mild group reported a two point improvement in VAS scores in compared to 35% of patients in the ESI group. There was a significant improvement in Oswestry disability scores in the mild group at six weeks (p<0.05), while in the ESI group improvement was not statistically significant. There were no procedure-related or device-related complications in either group. At six weeks, 17 of 21 patients in the ESI group crossed over to the mild procedure. Comparative 12 week outcome data was therefore not available. It is difficult to draw conclusions from this study due to the small number of participants and lack of data on long term outcomes. In addition, patients in the ESI group were treated with a single interlaminar injection; which is generally not typical of ESI treatment. An observational study conducted by Mekhail et al. (2011) at 11 sites reported one year outcome data on 58 patients treated for spinal stenosis with the mild procedure, with statistically significant improvement in VAS scores and ODI. A single-site case series conducted by Mekhail et al. in 2012 reported 12-month outcomes for 40 consecutive patients treated for spinal stenosis with the mild procedure. There was significant functional improvement and decreased disability as measured by the Pain disability index (PDI), Roland-Morris Disability Questionnaire, walking distance, standing time, and VAS scores. Deer and Kapurai (2010) published a retrospective review to evaluate the acute safety of the mild procedure. Charts of 90 consecutive patients who underwent the mild procedure for decompression of central lumbar stenosis were reviewed. No major adverse events or complications related to the devices or procedure were reported. There were no incidents of dural puncture or tear, blood transfusion, nerve injury, epidural bleeding or hematoma. Because the review did not include outcome data, no determination as to clinical efficacy can be made. The authors stated that prospective randomized studies have been initiated to collect patient outcomes data regarding post-treatment pain and functional capacity. Chopka and Caraway (2010) published a preliminary report of MiDAS I (mild Decompression Alternative to Open Surgery, a multi-center prospective case series to evaluate the mild procedure for treatment of symptomatic lumbar spinal stenosis. The procedure was offered as an alternative to surgery or continued medical management. No major device or procedure-related complications were reported. At six weeks, statistically significant reduction of pain as measured by the Visual Analog Scale, Oswestry Disability Index, and Zurich Claudication Questionnaire, and Standard Form -12. (SF-12). There is insufficient evidence in the medical literature to demonstrate the safety and efficacy percutaneous laminotomy/laminectomy approaches, including the mild procedure. Additional well designed trials with long-term outcome data are needed to determine how this procedure compares to available alternative treatments for lumbar stenosis.

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Thermal Intradiscal Procedures Intradiscal Electrothermal Annuloplasty (e.g., intradiscal electrothermal therapy [IDET™]) Intradiscal electrothermal annuloplasty (IEA), also referred to as intradiscal electrothermal therapy (IDET™), intradiscal electrothermal percutaneous annuloplasty, intradiscal thermal annuloplasty, or targeted intradiscal thermal therapy. is a minimally invasive procedure that has been proposed as an alternative to spinal fusion for the treatment of chronic discogenic low back pain. Following a provocative discogram, IEA is performed by inserting a catheter into the annulus and threading a flexible electrode through the catheter and around the inside of the disc, pressing against the posterior edge of the annulus. The electrode is then heated to a temperature of 90º F for up to 17 minutes. Analgesics and/or antibiotics are then injected and the catheter is withdrawn. The heating of the electrode denatures the collagen of the annulus and coagulates the nerve endings, with the ultimate goal of relieving back pain. A randomized, double-blind controlled trial was conducted by Freeman et al. (2005) to test the safety and efficacy of IEA compared with placebo for treatment of chronic discogenic low back pain. Patients with one- or two-level symptomatic disc degeneration with posterior or posterolateral annular tears who failed to improve after conservative therapy were considered for the study. Patients were randomized on a 2:1 ratio to IEA (n=38) or a sham procedure (n=19). An independent technician connected the catheter to the generator and delivered electrothermal energy to only the treatment group. Surgeon, patient, and independent outcome assessor were all blinded to the treatment. Low Back Outcome Score (LBOS), Oswestry Disability Index, SF-36, the Zung Depression Index (ZDI) and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and at six months. Successful outcome was defined as no neurological deficit, improvement in LBOS of greater than seven points, and improvement in SF-36 subsets (i.e., physical function and bodily pain) of greater than one standard deviation. No patient in either group showed improvement of greater than seven points in LBOS or greater than one standard deviation in the specified SF-36 domains. Mean ODI was 41.42 at baseline and 39.77 at six months for the IEA group compared with 40.74 at baseline and 41.58 at six months for the placebo group. There was no significant change in ZDI or MSPQ for either group. The authors concluded that there was no significant benefit from IEA over placebo. Pauza et al. (2004) conducted a prospective, randomized controlled trial comparing IEA with placebo. Sixty-four patients were randomized to receive IEA or sham treatment. The subjects were not aware of which treatment they received. Outcome tools used were the VAS, the SF-36, and the Oswestry Disability Scale. It is unclear whether the post-procedure outcome examiners were blinded regarding which patients received true IEA. The modest success rates reported in this trial were much less compelling than those from previously published uncontrolled studies. The investigators reported that both groups showed improvement, with mean improvements higher in the active treatment arm. Using the VAS, IEA demonstrated a 2.4-point decrease in the mean pain score. An 11-point decrease was reported in the mean Oswestry score. The baseline disability level of most of the patients was low, and recruitment methods may have led to patient selection bias. The sample size was insufficient to achieve adequate statistical power, and follow-up was limited to six months. In addition, eight patients who dropped out of the study were not included in the data analysis. While the results of this study suggest that IEA may improve outcomes for patients with discogenic low back pain, these methodological flaws make it impossible to draw valid conclusions about the efficacy of this technology. A systematic review of percutaneous thermocoagulation intradiscal techniques for discogenic low back pain (Urrutia, et al., 2007) included six studies (283 patients) of IEA and percutaneous intradiscal radiofrequency thermocoagulation (PIRFT). The studies included in the review of IEA consisted of two randomized controlled trials (Freeman and Pauza, discussed above), and two nonrandomized trials. One of the nonrandomized trials assessed the effectiveness of IEA vs. a rehabilitation program consisting of physical therapy, exercise, education and counseling, and the other compared IEA to PIRFT. In both randomized controlled trials that assessed IEA vs. placebo, pain, disability, and quality of life were assessed for six months. There was a small difference in favor of IEA in one study (Pauza), although the difference in disability was clinically irrelevant, while there was no difference in the higher-quality, more recent study (i.e., Freeman). The Freeman study also assessed depression, sitting and work tolerance, medication and neurologic deficit, and found no difference between IEA and placebo. In the nonrandomized trial comparing IEA and a rehabilitation program, the proportion of patients with a ≥ 50% reduction in pain was higher in the IEA group at both 12 and 24 months. The authors concluded that the available evidence does not support the efficacy or effectiveness of percutaneous thermocoagulation intradiscal techniques for the treatment of discogenic low back pain. The authors noted that previous case reports suggested that the procedure might be effective, but these reports, derived from data registries, could not take into account the effect of regression to the mean, the natural history of the condition,

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the placebo effect, and other potential confounders such as co-interventions and other mechanical and psychosocial factors. Freeman (2006) conducted a systematic review of the evidence of the efficacy of IEA. The review included 11 prospective cohort studies, five retrospective studies, and two randomized controlled trials. The prospective cohort studies reported on a total of 256 patients with a mean follow-up of 17.1 months (range 12–28 months). The mean improvement in the VAS for back pain was 3.4 points (range 1.4–6.5), and the mean improvement in ODI was 5.2 points (range 4.0–6.4) The five retrospective studies included 379 patients and reported that between 13 and 23% of patients subsequently underwent surgery for low back pain within the study period. The two randomized controlled trials, Pauza, 2004 and Freeman, 2005, provided inconsistent evidence, as described above. The author concluded that the evidence for efficacy of IEA remains weak and has not passed the standard of scientific proof. An ECRI Institute Emerging Technology Evidence Report on intradiscal electrothermal annuloplasty (IEA) for discogenic pain (2000, updated 2009) evaluated two randomized controlled trials with six-month follow-up (Pauza [2004] and Freeman [2005]), discussed above), three prospective case series, and one prospective case-control series. The studies included a total of 308 patients, and all studies had important design and reporting shortcomings that affect the reliability of results. The sample sizes were very small, follow-up times were very brief, and the results may not be generalizable to a larger population. In addition, none of the studies compared the effects of IEA to competing treatments for discogenic pain. The ECRI report states that the clinical significance of the IEA treatment effect cannot be definitively determined because the published randomized controlled trials reported conflicting very short-term outcomes, and because of the likely possibility of the placebo effect, given the waxing and waning nature of discogenic pain. It is also not possible to determine whether the reports of increased function and decreased pain in the reported case series data result from IEA or other factors (e.g., activity restriction, spontaneous improvement, or post-treatment therapy).

ASA 2010 Practice Guidelines for Chronic Pain Management states that Thermal intradiscal procedures: intervertebral disc annuloplasty (IDET) may be considered for young, active patients with early single-level degenerative disc disease with well-maintained disc height.

ACOEM evidence-based practice guidelines on low back disorders (2011) states that IDET is not recommended for treatment of acute, subacute, or chronic low back pain or any other back-related disorder. Updated American Society of Interventional Pain Physicians (ASIPP) Evidence-Based Practice Guidelines in the Management of Chronic Spinal Pain (Manchicanti, et al., 2013).state that the evidence for IDET is limited to fair, and that the procedure may be performed in a select group of patients with discogenic pain non-responsive to conservative modalities, including epidural injections. The safety, efficacy, and long-term outcomes of intradiscal electrothermal annuloplasty in the treatment of patients with chronic discogenic low back pain have not been established in the published medical literature. This procedure has not been proven to achieve equivalent or improved patient outcomes compared to available and established alternatives. In addition, the long-term effect of thermal coagulation of intervertebral discs has not been determined. Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT)/ Intradiscal Radiofrequency Thermomodulation/Percutaneous Radiofrequency Thermomodulation PIRFT may also be referred to as intradiscal radiofrequency thermomodulation or percutaneous radiofrequency thermomodulation. This procedure, used to treat chronic discogenic low back pain, is similar to intradiscal electrothermal therapy (IDET). With IDET, a catheter with a temperature-controlled, thermal-resistive coil is inserted under fluoroscopic guidance into the posterior annular wall of the affected disc, causing annular denervation. With PIRFT, the catheter is placed into the center of the disc rather than the annulus. The mechanism of reported clinical improvement with PIRFT is unclear, since the temperature at the annulus has been found to be well below the temperature required for annular denervation (Davis, 2003). Urrutia et al. (2007) conducted a systematic review to evaluate the evidence for the percutaneous thermocoagulation intradiscal techniques IDET and PIRFT in the treatment of discogenic low back pain. Six studies with a total of 283 patients were included. Two randomized controlled trials, including the Barendse trial described below, showed no differences between PIRFT and placebo and between different PIRFT techniques.

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The authors stated that, although previous case reports and nonrandomized trials suggested positive results, results from randomized clinical trials show that PIRFT is not effective for the treatment of discogenic low back pain. Barendse et al. (2001) conducted a randomized, double-blind, placebo-controlled trial of PIRFT using the Radionics discTRODE™ RF annuloplasty system. The Radionics system was approved by the U.S. Food and Drug Administration (FDA) through the 510(k) process in October 2000. A total of 28 patients were selected who had a history of at least one year of chronic low back pain, evidence of radiculopathy on neurological examination and a positive response to discography. Patients were randomly assigned to one of two treatment groups. Patients in the radiofrequency group (n=13) received a 90-second 70 degree centigrade (C) lesion of the intervertebral disc. Patients in the control group (n=15) underwent the same procedure but without the use of radiofrequency current. The treating physician and patients were blinded to group assignment. Patients were assessed by a blinded investigator before treatment and eight weeks after treatment. There was no difference between the two groups based on visual analog scores for pain, global perceived effect and the Oswestry disability scale. The treatment was considered a success in one patient in the radiofrequency group and two patients in the control group. The authors concluded that PIRFT is not effective in reducing chronic discogenic low back pain. Updated American Society of Interventional Pain Physicians (ASIPP) Evidence-Based Practice Guidelines in the Management of Chronic Spinal Pain (Manchicanti, et al., 2013) state that the evidence is limited for discTRODE (PIRFT). According to the evidence-based clinical practice guideline from the American Pain Society, Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain (Chou et al., 2009), the level of evidence for PIRFT is poor. The authors were unable to estimate the net benefit of the procedure in the treatment of patients with nonradicular low back pain. American College of Occupational and Environmental Medicine (ACOEM) practice guidelines on low back disorders, (2011) states that PIRFT is strongly not recommended for treatment of acute, subacute, or chronic low back pain, particularly including discogenic low back pain. There is insufficient evidence in the published medical literature to demonstrate the safety, efficacy and long-term outcomes of PIRFT. There is no evidence that this procedure is as effective as established alternatives for the treatment of back pain. Intervertebral Disc Biacuplasty/Cooled Radiofrequency The Baylis TransDiscal™ system (Baylis Medical Inc., Montreal Canada) is used to perform intervertebral biacuplasty. The TransDiscal system received FDA approval through the 510(k) process on December 19, 2006. The system is designed to deliver controlled RF energy via two electrodes. Two TransDiscal Probes and the Pain Management Pump Unit, connected to the Baylis Pain Management Generator, work in concert to deliver RF energy. The system is intended to be used to create RF lesions in nervous tissue, including that which is situated in intervertebral disc material Separate components of the system had previously received FDA approval; the 2006 approval combined the indications of the predicate devices. (U.S. FDA website). Intervertebral biacuplasty using the TransDiscal system has been investigated in the treatment of lumbar discogenic pain. The procedure is performed using a bipolar approach in conjunction with internally water-cooled RF probes to coagulate and decompress disc material. Two introducers are placed bilaterally in the posterolateral discs and the TransDiscal probes are then inserted into the introducers. RF energy is applied and directed through the disc between the two probe electrodes. The cooling system is designed to maintain and balance the temperature in each probe, allowing RF energy to be delivered with greater power to heat a larger volume of disc tissue, while avoiding overheating of adjacent tissue. Kapurai et al. (2013) conducted a randomized controlled trial to evaluate transdiscal radiofrequency biacuplasty (IDB) for discogenic lower back pain (n=59). Twenty nine patients were randomized to IDB and 30 to a sham procedure. All had a history of chronic low back pain for longer than six months. The primary outcome measures were physical function, pain, disability, and opioid usage. At six months, there were statistically significant improvements in the treated group compared to the control group in physical function (p=0.129), pain (p=0.006), and disability (p=0.037). There was no significant difference between groups in opioid usage. Limitations of the

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study include lack of long-term follow-up and small sample size. Of 1894 patients screened, only 59 were included. Kapural et al. (2008) conducted a pilot study (n=15) of intervertebral disc biacuplasty in the treatment of lumbar discogenic pain. Included patients had a history of chronic low back pain unresponsive to nonoperative care for greater than six months, back pain exceeding leg pain, concordant pain on provocative discography, disc height > 50% of control, and evidence of single-or tow-level degenerative disc disease without evidence of additional changes on MRI. Outcomes were evaluated by questionnaire at one, three and six months. Median VAS pain score decreased from 7 cm at baseline to 4 cm at one month and 3 cm at six months. The Oswestry score improved from 23.3 to 16.5 at one month, with similar results at six months. The SF-36 physical functioning scores improved from 51 to 70 points at six month, and the Bodily Pain score improved from 38 to 54. There was no significant change from baseline in daily opioid use. No procedure-related complications were reported. Updated ASIPP guideline referenced above (Manchicanti, et al., 2013) state that the evidence for biacuplasty is limited to fair, and that the procedure may be performed in a select group of patients with discogenic pain non-responsive to conservative modalities, including epidural injections. There is insufficient evidence in the published medical literature to demonstrate the safety, efficacy and long-term outcomes of intervertebral disc biacuplasty. Coblation® Nucleoplasty™/Disc Nucleoplasty/Decompression Nucleoplasty/Plasma Disc Decompression Coblation Nucleoplasty, also referred to as disc nucleoplasty, decompression nucleoplasty, or plasma disc decompression, is a minimally invasive technique for decompression of contained herniated discs using the Arthrocare Perc-D Coblation Spine Wand. The Spine Wand is a bipolar radiofrequency device designed to decompress the disc nucleus with energy and heat. The tip of the wand is slightly curved to allow channeling. Nucleoplasty uses Coblation technology, which generates a low temperature plasma field intended to allow precise ablation with minimal risk of thermal injury. The tip temperature is 50–70 degrees C. A plasma field, a millimicron-thick layer of highly energized particles, causes molecular dissociation of the disc material directly in front of the tip. This creates a channel from the posterolateral annulus to the anteromedial annulus. During withdrawal, the coagulation mode is used. Six separate channels are typically created. The thermal effect is reported to result in denaturization of the Type II collagen, causing shrinkage of the surrounding collagen and widening of the channel (Sharps, et al., 2002; Singh, et al., 2003; Davis, 2003) There are no published randomized controlled trials evaluating nucleoplasty in the medical literature; studies consist primarily of small uncontrolled case series (Sharp and Isaac [2002]; Singh et al. [2003]; Bhagia et al. [2006]). A Cochrane review of surgery for lumbar disc prolapse (Gibson and Waddell, 2007) states that, unless or until better scientific evidence is available, Coblation therapy should be regarded as a research technique. Updated ASIPP Practice Guidelines for the Management of Chronic Spinal Pain (2013) state that the evidence is limited to fair for nucleoplasty, and that the procedure is recommended in select cases. The evidence-based clinical practice guideline from the American Pain Society, Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain (Chou et al., 2009), states that there are no trials evaluating Coblation nucleoplasty. The authors were unable to estimate the net benefit of the procedure in the treatment of patients with back pain, with or without radiculopathy. ACOEM evidence-based practice guidelines on low back disorders, surgical considerations (2011) state that there is no quality evidence that Coblation therapy is an effective treatment for any back or radicular pain problem. The safety, efficacy and long-term outcomes of this Coblation nucleoplasty have not been demonstrated in the published medical literature. In addition, the long-term consequences of thermal denervation and tissue damage associated with this procedure are unknown. Oxygen/Ozone Injection

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Intradiscal oxygen-ozone injection has been proposed as a minimally invasive treatment of lumbar disc herniation. Ozone is reported to be a strong oxidizer that rapidly reacts and oxidizes the proteoglycans in the nucleus pulposus. The procedure is based on the premise that a small reduction in disc volume may result in a significant reduction in pain. The technique is similar to discography and other percutaneous disc procedures. Under image guidance, a needle is positioned into the nucleus pulposus, 1-3 ml of oxygen/ozone from a medical ozone generator is injected into the disc, and 7-9 ml is injected into the paravertebral muscle surrounding the disc. A pain suppressant (e.g., bupivacaine) and/or corticosteroid may also be injected. Oxygen/ozone injection is primarily practiced in Europe and Asia. No medical ozone generators for use in intradiscal injection have received U.S. Food and Drug Administration (FDA) approval. A metaanalysis of the effectiveness and safety of ozone treatments for herniated lumbar discs conducted by Steppan et al. (2010) reported a mean improvement of 3.9 for Visual Analog Scale (VAS) and 25.7 for Oswestry Disability Index (ODI). The likelihood for showing improvement on the Modified McNab outcome scale was reported as 79.7%, and the likelihood of complications, 0.064%. It is difficult to draw firm conclusions from this analysis due to the quality of included studies. Of 11 included studies, 9 were retrospective, 2 were prospective, and one consisted of unpublished data. In some studies data required for metaanalysis was not reported, and was estimated by the authors. There is insufficient evidence in the published medical literature to demonstrate the safety and efficacy of ozone injection or to determine how this treatment compares to other available treatment options for disc herniation. In addition, no medical ozone generators have received FDA approval. Epiduroscopy/Epidural Myeloscopy/Epidural Spinal Endoscopy, Racz Procedure, Epidural Adhesioloysis (Percutaneous or Endoscopic) Epiduroscopy, the Racz procedure, percutaneous epidural adhesiolysis and spinal endoscopic adhesiolysis have been proposed as methods of diagnosing and/or treating intractable low back pain and lower extremity pain. Epiduroscopy: Epiduroscopy, also referred to epidural myeloscopy or epidural spinal endoscopy, is a technique that uses an epiduroscope to visualize the epidural space. It is used in the diagnosis and treatment of intractable low back pain, especially in patients with radiculopathy. Scarring of the epidural space occurs in approximately 50% of patients who have undergone multiple surgeries for back pain. This may lead to formation of epidural fibrosis, adhesions of the nerve root, causing recurrence of pain. In epiduroscopy, a needle is advanced into the sacral canal through which a guide-wire is inserted and advanced. The needle is replaced with an introducer sheath through which an endoscope is inserted. Saline is flushed through the system to expand the sacral space, which can then be examined through the endoscope. Although epiduroscopy may be performed as a diagnostic procedure, it is usually performed in conjunction with the Racz procedure or epidural adhesiolysis. There is no evidence in the published medical literature to support the use of epiduroscopy as a diagnostic procedure. There is no evidence that this invasive technique provides clinically useful information not available with current noninvasive diagnostic methods. Racz Procedure: The Racz procedure is a method of epidurolysis in which a Racz catheter is inserted under fluoroscopy into the epidural space and a mixture of local anesthetic, steroid, contrast dye and concentrated saline solution is injected. The procedure is performed under local anesthesia with intravenous sedation and analgesics, generally on an inpatient basis. The catheter remains in place overnight, and the injection is repeated on the second and third day. Percutaneous and endoscopic adhesiolysis are modifications of the Racz procedure but do not generally require an inpatient stay. Epidural Adhesiolysis (Percutaneous or Endoscopic): Percutaneous epidural adhesiolysis, or percutaneous epidural lysis of adhesions is intended to eliminate the effects of scar formation which can prevent direct application of drugs used to treat chronic back and extremity pain. Percutaneous epidural adhesiolysis is intended to assure delivery of high concentrations of injected drugs to the target area. The procedure is generally performed by introducing a needle into the epidural space under fluoroscopy, performing a lumbar epidurogram to identify the filling defects, and inserting a Racz catheter through the needle to the area of the filling defect or site of pathology as determined by MRI, CT or patient symptoms. Adhesiolysis is performed by saline injections and mechanical manipulation of the catheter, followed by injection of anesthetic, steroid, and additional normal or hypertonic saline. Serious complications of epidurolysis may include paralysis, bowel/bladder dysfunction and acute bilateral vision loss during or shortly after the procedure. Less serious but

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more common complications include infection, subarachnoid block, lower body paresthesia, perineal numbness, neck pain, and headache requiring epidural and caudal blood patches. A randomized, double-blind trial was conducted to analyze the clinical efficacy of percutaneous epidural lysis of adhesions in chronic radicular pain (Gerdesmeyer et al., 2013). Of 381 patients screened, 90 patients with chronic radicular pain that failed to respond to conservative treatment were included in the trial, and randomized to percutaneous neurolysis (n=46) or placebo (n=44). Patients were hospitalized and underwent a three day treatment regimen. For the placebo group, a needle and catheter were inserted into the subcutaneous tissue and did not enter the spinal canal. The ODI scores in the lysis group improved from 55.3 ± 11.6 to 26.4 ± 10.8 at 3 months and 9.6 ± 9.3 at 12 months, compared to improvement in the placebo group from 55.4 ± 11.5 to 41.8 ± 14.6 at 3 months and 30.7 ± 14.2 at 12 months (p< 0.01). VAS improved in the lysis group from 6.7 ± 1.1 to 2.9 ± 1.9 at 3 months and 1.2 ± 1.0 at 12 months, compared to improvement in the placebo group from 6.7 ± 1.1 to 4.8 ± 2.2 at 3 months and 2.8 ± 1.5 at 12 months (p<0.01). A limitation of the study noted by the authors is that the effect of each treatment component is unknown and no recommendation can be made regarding whether the full cycle of treatment and parameters used in the percutaneous lysis of adhesions is necessary to achieve these results, or if one option such as hyaluronidase, hypertonic saline, dosage of cortisone, and mechanical catheter effect or just the volume injected may not have a significant effect on outcome. The authors stated that the specific effects of each single parameter should be the focus of further studies. Additional limitations of the study include the placebo effect, and the inability to determine whether adhesions recurred or how much lysis of adhesions correlates with clinical effects due to lack of follow-up MRI. Helm et al. (2012) conducted a systematic review to evaluate percutaneous adhesiolysis in the treatment of refractory low back and leg pain due to post lumbar surgery syndrome or spinal stenosis. The Cochrane Musculoskeletal Review Group criteria were utilized for quality assessment and clinical relevance determination. The level of evidence was classified as good, fair and limited based on the quality of evidence developed by the U.S. Preventive services task Force (USPSTF). The primary outcome measure was pain relief of at least six months, and secondary outcome measures were improvement in functional status, change in psychological status, return to work and reduction in opioid use or interventions. Five randomized controlled trials and two observational studies met the inclusion criteria. Based on three high quality trials with positive results, and one trial with indeterminate results, using the USPSTF criteria, the evidence is fair that adhesiolysis is effective in the treatment of chronic, low back and leg pain due to post lumbar surgery syndrome. Based on one high quality randomized controlled trial and one moderate quality observational study, the evidence is fair that adhesiolysis is effective in the treatment of chronic low back and leg pain due to spinal stenosis. Veihelmann et al. (2006) conducted a randomized controlled trial to evaluate epidural neuroplasty (i.e., adhesiolysis) compared to physiotherapy in patients with chronic low back pain and sciatica. Leg pain, back pain, and Oswestry disability scores were assessed by questionnaire prior to and following treatment. At three months’ follow-up, the mean disability score had decreased from 23 ± 9 to 11 ± 7 in the adhesiolysis group, and had decreased from 21 ± 8 to 18 ± 8 in the physiotherapy group. This decrease was statistically significant. The mean leg pain score decreased 67% with adhesiolysis compared to a 16% decrease with physical therapy, and the mean back pain score decreased 68% with adhesiolysis compared to a 10% decrease with physical therapy. These improvements were also statistically significant. A significant limitation of this study is the fact that a total of 13 (25%) of the patients in the physical therapy group were not available for follow-up at three months. In addition, pain and disability were assessed at six and twelve months in patients who remained in the study, but 12 (23%) of the patients who remained and underwent physical therapy chose to undergo epidural adhesiolysis, and they were also excluded from the results. The authors stated that epidural neuroplasty seems to be an effective, safe, alternative treatment, but further prospective, randomized, double-blinded studies should be performed to prove the effectiveness of this procedure in comparison to placebo and in comparison to open discectomy procedures. Manchicanti et al. (2004) conducted a randomized controlled trial to determine the effectiveness of percutaneous adhesiolysis and hypertonic saline administration in reducing pain and improving functional and psychological status of patients with chronic low back pain. A total of 75 patients were divided into three treatment groups. Group I, the control group, received catheterization without adhesiolysis followed by injection of local anesthetic, normal saline and steroid. Group II received catheterization and adhesiolysis followed by injection of local anesthetic, normal saline and steroid. Group III received adhesiolysis followed by injection of local anesthetic, hypertonic saline and steroid. The authors reported 72% of patients in group II and 60% of patients in group III showed significant improvement at 12-month follow-up, compared to 0% in group I. Patients

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in groups II and III received an average of 2.76 and 2.16 treatments respectively in the 12-month period. The duration of significant relief averaged 2.8 ± 1.49 months in group II and 3.8 ± 3.37 months in group III. The authors concluded that percutaneous adhesiolysis with or without hypertonic saline neurolysis is an effective treatment for chronic back pain. Of the 25 patients in the control group, however, one was lost to follow-up and 18 were unblinded prior to completion of the study. These findings cannot be generalized due to the small size of this study, lack of outcome data for patients in the control group, and lack of long-term outcomes. Endoscopic epidural adhesiolysis is performed by inserting a needle into the sacral canal and inserting and advancing a guide wire. The needle is replaced with an introducer sheath through which a fiberoptic endoscope is inserted. Saline is flushed through the system to distend and decompress the epidural space, and mechanical manipulation of the endoscope causes direct disruption of fibrosis, scar tissue or adhesions. Anesthetic and steroid are then injected. Manchicanti et al. (2005) randomized 83 patients with chronic lower back pain to endoscopy at the sacral level without adhesiolysis, followed by injection of steroid and local anesthetic with steroid injection (n=33; group I) or to endoscopic adhesiolysis followed by injection of local anesthetic and steroid (n=50; group II). Endoscopic adhesiolysis was associated with significant improvements in all outcome measures at 12 months’ follow-up. The mean pain score was reduced by 37% in group II compared to only 3% in group I, representing a statistically significant difference (p=0.001). The mean Oswestry disability score improved by 31% in group II compared to 3% in group I (p=0.001). Greater improvements in spinal range of motion and psychological status were also seen in group II. The average duration of > 50% pain relief was 7.6 ± 4.7 months. Although positive results were reported, it is difficult to draw definitive conclusions from this study, since 33 patients (40%) were not available for the 12-month follow-up. There are few published studies that evaluate endoscopic epidural adhesiolysis. Manchicanti et al. (2003) published preliminary results of a small (n=39) randomized, double-blind trial to determine the ability of spinal endoscopic adhesiolysis to reduce pain and improve functional and psychological status. Patients randomized to group I (n=14) were treated with endoscopy without adhesiolysis followed by injection of local anesthetic and steroid. Patients randomized to group II (n=23) were treated with spinal endoscopy and adhesiolysis followed by injection of local anesthetic and steroid. The authors reported significant relief of pain in 13 of 23 patients in group II immediately after treatment and at one, three and six months, and significant improvement in psychological and behavior outcomes, while no patients in group I showed significant improvement at six months. Although designed as a double-blind study, 25 of 39 patients were unblinded at three months. These findings cannot be generalized due to the small size of this study and lack of long-term outcomes. The updated American Society of Interventional Pain Physicians (ASIPP) practice guideline, Interventional Techniques in the Management of Chronic Spinal Pain (Manchicanti, et al., 2009 2013), states that the evidence for lumbar epidural adhesiolysis in managing chronic low back and leg pain secondary to post lumbar surgery syndrome is fair to good and for spinal stenosis is fair. The procedure is recommended after failure of conservative management and fluoroscopically directed epidural injections. American College of Occupational and Environmental Medicine (ACOEM) practice guidelines on low back disorders, (2011) state that adhesiolysis is not recommended to treat acute, subacute or chronic low back pain, spinal stenosis, or radicular pain syndromes. There is insufficient evidence in the published medical literature to support the use of epiduroscopy, the Racz procedure, or percutaneous/endoscopic epidural adhesiolysis in the diagnosis or treatment of back pain. There are no published, well-designed, prospective clinical trials of adequate size that evaluate these procedures nor is there information available regarding long-term outcomes. The safety, efficacy and long-term outcomes of these procedures have not been established. Devices for Annular Repair Following Spinal Surgery Discectomy procedures involve removal of a bony portion of the vertebral body to access the posterior side of the disc space, and removal of the impinging fragment from the disc. This fragment may be within the wall of the anulus, requiring incision into the anulus to remove it. Sutures may be placed to seal the annular defect to reduce recurrent herniation following discectomy. The Inclose™ Surgical Mesh System and the Xclose™ Tissue Repair System (Anulex Technologies, Inc., Minnetonka, MN) have been proposed for annular repair following discectomy as an alternative method to re-approximate the compromised tissue of the anulus fibrosus. Use of

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the Xclose system for this indication, however is beyond the scope of the FDA 510 (k) clearance, detailed below. The Inclose Surgical Mesh System received FDA approval through the 510(k) process on August 18, 2005. According to the 510(k) summary, the device is comprised of a mesh implant and two suture assemblies (anchor bands). The mesh implant is an expandable braided patch that is inserted through the aperture of the tissue defect and affixed to surrounding soft tissue with the anchor bands. The product may be used to support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material, such as the repair of groin hernias. The Xclose Tissue Repair System received FDA approval through the 510(k) process on August 7, 2006. The system is described in the 510(k) summary as consisting of two non-absorbable braided surgical 3-0 suture and T-anchor assemblies connected with a loop of green 2-0 suture. The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture assemblies together and re-approximating the tissue. The system is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery. There is inadequate evidence to demonstrate the safety and efficacy of these devices or to determine the impact on patient outcomes compared to standard surgical techniques. In addition to the procedures described above, several recently introduced techniques combine established surgical approaches for disc removal with additional procedures for which safety and efficacy has not been established, including radiofrequency, laser or other disc ablation and modulation procedures (e.g., Disc-Fx [Elliquency Innovations, Oceanside NY]), selective endoscopic discectomy (SED). Use Outside the U.S. Guidance, National Institute for Health and Clinical Excellence (NICE) (United Kingdom) Automated percutaneous mechanical lumbar discectomy: Guidance issued by the National Institute for Health and Clinical Excellence (NICE) (United Kingdom) in 2005 states that current evidence suggests that although there are no safety concerns associated with automated percutaneous mechanical lumbar discectomy, and there is limited evidence of efficacy based on uncontrolled case series of heterogeneous groups of patients, evidence from small randomized controlled trials shows conflicting results. The guidance states that in view of uncertainty about the efficacy of the procedure, it should not be done without special arrangements for consent and for audit or research. Laser lumbar discectomy: NICE issued updated Interventional Procedure Guidance on percutaneous endoscopic laser lumbar discectomy in 2009, and issued guidance on percutaneous endoscopic laser cervical discectomy in 2009, stating that current evidence on the safety and efficacy of these procedures is inadequate in quantity and quality, and should only be used with special arrangements for consent and audit or research. Interventional Procedure Guidance on percutaneous endoscopic laser thoracic discectomy issued in 2004 states that current evidence on the safety and efficacy does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Percutaneous intradiscal electrothermal therapy: Updated NICE guidance issued in 2009, consistent with guidance issued in 2004, states that current evidence on the safety and efficacy of percutaneous intradiscal electrothermal therapy for low back pain is inconsistent, and should only be used with special arrangements for clinical governance, consent and audit or research. Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT): Interventional procedure guidance on PIRFT issued by NICE in 2004 states that current evidence on the safety and efficacy of this procedure does not appear adequate to support its use without special arrangements for consent and for audit or research. The published guidance states that evidence is based on a small number of patients and is difficult to interpret. It is unclear whether improvements are the result of the procedure or the natural course of the condition. Percutaneous disc decompression using Coblation: NICE Interventional Procedure Guidance published in May 2006 states that although there are no major safety concerns associated with percutaneous disc decompression using Coblation for low back pain, and there is some evidence of short-term efficacy, this is not sufficient to support its use without special arrangements for consent and for audit or research. The published guidance states that the lack of data makes it difficult to draw conclusions regarding the efficacy of the procedure. The lack of long-term and comparative data also makes it difficult to distinguish between the

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treatment effect and the natural history of the disease, or to determine whether the benefits are sustained beyond 12 months. Therapeutic endoscopic division of epidural adhesions: NICE issued updated Interventional Procedure Guidance on therapeutic endoscopic division of epidural adhesions in 2010, stating that current evidence is limited to some evidence of short-term efficacy, and there are significant safety concerns. This procedure therefore should only be used with special arrangements for consent and audit or research. Summary Most back pain will resolve spontaneously or can be treated with conservative therapies, such as pharmacological therapy (e.g., analgesics, anti-inflammatory drugs, muscle relaxants), exercise, physical therapy, spinal manipulation, and acupuncture. Trigger-point injections or epidural steroid injections may be considered for selected patients with pain that persists despite conservative treatment, although evidence on the long-term value of these injections is lacking. Consideration of an interdisciplinary approach with a cognitive-behavioral component is recommended for patients with nonradicular pain who do not respond to usual treatment. Standard open discectomy, or microdiscectomy, performed through a smaller (15–25 mm) central incision with the use of an operating microscope and direct visualization, may be performed for selected patients with remediable underlying pathology as determined by radiological findings. Laminectomy or laminotomy may be performed alone or in combination with discectomy to relieve pressure on the spinal cord or nerve roots. Percutaneous radiofrequency denervation of paravertebral facet joint nerves may also be considered in selected patients. Numerous alternative minimally invasive techniques and approaches have been proposed for the treatment of back and neck pain, as described above. There is insufficient evidence in the published medical literature to demonstrate the safety, efficacy and long- term outcomes of these procedures. There is no evidence that these procedures are as effective as established interventions for the treatment of back pain. Coding/Billing Information Note: 1) This list of codes may not be all-inclusive. 2) Deleted codes and codes which are not effective at the time the service is rendered may not be eligible for reimbursement 3) ICD-10-CM Diagnosis Codes are for informational purposes only and are not effective until 10/01/2015. Covered when medically necessary: Trigger Point Injections Covered when medically necessary when used to report trigger point injections: CPT®* Codes

Description

20552† Injection(s); single or multiple trigger point(s), one or two muscle(s) 20553† Injection(s); single or multiple trigger point(s), three or more muscle(s)

†Note:: Experimental/Investigational/Unproven/Not Covered when used to report dry needling of trigger points ICD-9-CM Diagnosis Codes

Description

723.1 Cervicalgia 723.8 Other syndromes affecting cervical region 724.1 Pain in thoracic spine 724.2 Lumbago

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724.5 Backache, unspecified 724.8 Other symptoms referable to back 724.9 Other specified back disorders

ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

M43.8x9 Other specified deforming dorsopathies, site unspecified M53.80 Other specified dorsopathies, site unspecified M53.81 Other specified dorsopathies, occipito-atlanto-axial region M53.82 Other specified dorsopathies, cervical region M53.83 Other specified dorsopathies, cervicothoracic region M53.84 Other specified dorsopathies, thoracic region M53.85 Other specified dorsopathies, thoracolumbar region M53.9 Dorsopathy, unspecified M54.2 Cervicalgia M54.5 Low back pain M54.6 Pain in thoracic spine M54.81 Occipital neuralgia M54.89 Other dorsalgia M54.9 Dorsalgia, unspecified

Experimental/Investigational/Unproven/Not Covered: ICD-9-CM Diagnosis Codes

Description

All other codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All other codes Experimental/Investigational/Unproven/Not Covered when used to report dry needling of trigger points: CPT®* Codes

Description

64999 Unlisted procedure, nervous system ICD-9-CM Diagnosis Codes

Description

All codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All codes

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Not Medically Necessary/Not Covered when used to report guidance for trigger point injections: CPT®* Codes

Description

76942 Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation

ICD-9-CM Diagnosis Codes

Description

All codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All codes Epidural Steroid Injections Covered when medically necessary: CPT®* Codes

Description

62310 Injection(s) of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic.

62311 Injection(s) of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal)

64479 Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, single leve

64480 Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional level (List separately in addition to code for primary procedure)

64483 Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, single level

64484 Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional level (List separately in addition to code for primary procedure)

ICD-9-CM Diagnosis Codes

Description

353.2 Cervical root lesions, not elsewhere classified 353.3 Thoracic root lesions, not elsewhere classified 353.4 Lumbosacral root lesions, not elsewhere classified 722.0 Displacement of cervical intervertebral disc without myelopathy 722.10 Displacement of lumbar intervertebral disc without myelopathy 722.11 Displacement of thoracic intervertebral disc without myelopathy 722.81 Postlaminectomy syndrome; cervical region 722.82 Postlaminectomy syndrome; thoracic region 722.83 Postlaminectomy syndrome; lumbar region

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723.0 Spinal stenosis in cervical region 723.4 Brachial neuritis or radiculitis, NOS 724.00-724.09

Spinal stenosis, other than cervical

724.3 Sciatica 724.4 Thoracic or lumbosacral neuritis or radiculitius, unspecified

ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

G54.2 Cervical root disorders, not elsewhere classified G54.3 Thoracic root disorders, not elsewhere classified G54.4 Lumbosacral root disorders, not elsewhere classified M47.021-M47.029 Vertebral artery compression syndromes M48.00-M48.08 Spinal stenosis M50.10-M50.13 Cervical disc disorder with radiculopathy M50.20-M50.23 Other cervical disc displacement M51.14-M51.17 Intervertebral disc disorders with radiculopathy M51.24-M51.27 Other intervertebral disc displacement M53.3 Sacrococcygeal disorders, not elsewhere classified M54.11-M54.17 Radiculopathy M54.30-M54.32 Sciatica M54.40-M54.42 Lumbago with sciatica M96.1 Postlaminectomy syndrome, not elsewhere classified M99.20-M99.29 Subluxation stenosis of neural canal M99.30-M99.39 Osseous stenosis of neural canal M99.40-M99.49 Connective tissue stenosis of neural canal M99.50-M99.59 Intervertebral disc stenosis of neural canal M99.60-M99.69 Osseous and subluxation stenosis of intervertebral foramina M99.70-M99.79 Connective tissue and disc stenosis of intervertebral foramina

Experimental/Investigational/Unproven/Not Covered: CPT* Codes Description 0228T Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with

ultrasound guidance, cervical or thoracic; single level 0229T Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with

ultrasound guidance, cervical or thoracic; each additional level (List separately in addition to code for primary procedure)

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0230T Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, lumbar or sacral; single level

0231T Injection(s), anesthetic agent and/or steroid, transforaminal epidural, with ultrasound guidance, lumbar or sacral; each additional level (List separately in addition to code for primary procedure)

ICD-9-CM Diagnosis Codes

Description

All codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All codes Facet Joint Injections Covered when medically necessary when used to report diagnostic facet joint injections: CPT®* Codes

Description

64490 Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; single level

64491 Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; second level (List separately in addition to code for primary procedure)

64492 Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), cervical or thoracic; third and any additional level(s) (List separately in addition to code for primary procedure)

64493 Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; single level

64494 Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; second level (List separately in addition to code for primary procedure)

64495 Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; third and any additional level(s) (List separately in addition to code for primary procedure)

ICD-9-CM Diagnosis Codes

Description

721.0 Cervical spondylosis without myelopathy 721.2 Thoracic spondlyosis without myelopathy 721.3 Lumbosacral spondylosis without myelopathy 722.81 Postlaminectomy syndrome; cervical region 722.82 Postlaminectomy syndrome; thoracic region 722.83 Postlaminectomy syndrome; lumbar region 723.1 Cervicalgia

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723.8 Other syndromes affecting cervical region 723.9 Unspecified musculoskeletal disorders and symptoms referable to neck 724.1 Pain in thoracic spine 724.2 Lumbago 724.5 Backache, unspecified 724.8 Other symptoms referable to back 724.9 Other specified back disorders

ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

M43.8x9 Other specified deforming dorsopathies, site unspecified M47.021-M47.029 Vertebral artery compression syndromes M47.11 Other spondylosis with myelopathy, occipito-atlanto-axial region M47.12 Other spondylosis with myelopathy, cervical region M47.13 Other spondylosis with myelopathy, cervicothoracic region M47.21-M47.28 Other spondylosis with radiculopathy M47.811-M47.818 Spondylosis without myelopathy or radiculopathy M47.891-M47.898 Other spondylosis M53.80 Other specified dorsopathies, site unspecified M53.81 Other specified dorsopathies, occipito-atlanto-axial region M53.82 Other specified dorsopathies, cervical region M53.83 Other specified dorsopathies, cervicothoracic region M53.84 Other specified dorsopathies, thoracic region M53.85 Other specified dorsopathies, thoracolumbar region M53.9 Dorsopathy, unspecified M54.2 Cervicalgia M54.5 Low back pain M54.6 Pain in thoracic spine M54.81 Occipital neuralgia M54.89 Other dorsalgia M54.9 Dorsalgia, unspecified M96.1 Postlaminectomy syndrome, not elsewhere classified

Experimental/Investigational/Unproven/Not Covered: ICD-9-CM Diagnosis Codes

Description

All other codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All other codes Experimental/Investigational/Unproven/Not Covered:

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CPT* Codes Description 0213T Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal)

joint (or nerves innervating that joint) with ultrasound guidance, cervical or thoracic; single level

0214T Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, cervical or thoracic; second level (List separately in addition to code for primary procedure

0215T Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, cervical or thoracic; third and any additional level(s) (List separately in addition to code for primary procedure)

0216T Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, lumbar or sacral; single level

0217T Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, lumbar or sacral; second level (List separately in addition to code for primary procedure)

0218T Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with ultrasound guidance, lumbar or sacral; third and any additional level(s) (List separately in addition to code for primary procedure)

ICD-9-CM Diagnosis Codes

Description

All codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All codes Sacroiliac (SI) Joint Injection Covered when medically necessary when localized SI joint pathology is confirmed on imaging studies: CPT®* Codes

Description

27096 Injection procedure for sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy or CT), including arthrography when performed

HCPCS Codes

Description

G0260 Injection procedure for sacroiliac joint; provision of anesthetic, steroid and/or other therapeutic agent, with or without arthrography

ICD-9-CM Diagnosis Codes

Description

714.0 Rheumatoid arthritis 715.15 Primary localized osteoarthrosis, pelvic region and thigh 715.18 Primary localized osteoarthrosis, other specified sites 715.25 Secondary localized osteoarthrosis, pelvic region and thigh 715.35 Localized osteoarthrosis not specified whether primary or secondary, pelvic

region and thigh

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715.95 Osteoarthrosis, unspecified whether generalized or localized, pelvic region and thigh

716.55 Unspecified polyarthropathy or polyarthritis, pelvic region and thig 716.95 Unspecified arthropathy, pelvic region and thigh 719.45 Pain in joint, pelvic region and thigh 720.0 Ankylosing spondylitis 720.2 Sacroiliitis, not elsewhere classified 724.2 Lumbago 724.3 Sciatica 724.5 Backache, unspecified 724.6 Disorders of sacrum 724.70-724.79

Disorders of coccyx

ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

M05.451-M05.459 Rheumatoid myopathy with rheumatoid arthritis of hip M05.49 Rheumatoid myopathy with rheumatoid arthritis of multiple sites M05.551-M05.559 Rheumatoid polyneuropathy with rheumatoid arthritis of hip M05.59 Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites

M05.79 Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement

M05.851-M05.859 Other rheumatoid arthritis with rheumatoid factor of hip M06.051-M06.059 Rheumatoid arthritis without rheumatoid factor, hip M06.08 Rheumatoid arthritis without rheumatoid factor, vertebrae M06.09 Rheumatoid arthritis without rheumatoid factor, multiple sites M06.251-M06.259 Rheumatoid bursitis, hip M06.29 Rheumatoid bursitis, multiple sites M06.351-M06.359 Rheumatoid nodule, hip M06.38 Rheumatoid nodule, vertebrae M06.39 Rheumatoid nodule, multiple sites M06.851-M06.859 Other specified rheumatoid arthritis, hip M06.871-M06.89 Other specified rheumatoid arthritis, multiple sites M06.871-M06.9 Rheumatoid arthritis, unspecified M08.1 Juvenile ankylosing spondylitis M12.9 Arthropathy, unspecified M13.0 Polyarthritis, unspecified M16.0 Bilateral primary osteoarthritis of hip M16.10-M16.12 Unilateral primary osteoarthritis, hip M16.2 Bilateral osteoarthritis resulting from hip dysplasia M16.31-M16.32 Unilateral osteoarthritis resulting from hip dysplasia M16.4 Bilateral post-traumatic osteoarthritis of hip

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M16.50-M16.52 Unilateral post-traumatic osteoarthritis, hip M16.6 Other bilateral secondary osteoarthritis of hip M16.7 Other unilateral secondary osteoarthritis of hip M16.9 Osteoarthritis of hip, unspecified M19.91 Primary osteoarthritis, unspecified site M25.551-M25.559 Pain in hip M45.7 Ankylosing spondylitis of lumbosacral region M45.8 Ankylosing spondylitis sacral and sacrococcygeal region M46.1 Sacroiliitis, not elsewhere classified M48.8x7 Other specified spondylopathies, lumbosacral region M48.8x8 Other specified spondylopathies, sacral and sacrococcygeal region M53.2x7 Spinal instabilities, lumbosacral region M53.2x8 Spinal instabilities, sacral and sacrococcygeal region M53.3 Sacrococcygeal disorders, not elsewhere classified M53.87 Other specified dorsopathies, lumbosacral region M53.88 Other specified dorsopathies, sacral and sacrococcygeal region M54.30-M54.32 Sciatica M54.40-M54.42 Lumbago with sciatica M54.5 Low back pain M54.89 Other dorsalgia M54.9 Dorsalgia, unspecified

Experimental/Investigational/Unproven/Not Covered: ICD-9-CM Diagnosis Codes

Description

All other codes. ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All other codes. Experimental/Investigational/Unproven/Not Covered: when used to report guidance for SI joint injections: CPT®* Codes

Description

76942 Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation

ICD-9-CM Diagnosis Codes

Description

All codes ICD-10-CM Diagnosis

Description

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Codes (Effective 10/01/2014) All codes

Ablative Treatment Covered when medically necessary when used to report percutaneous radiofrequency ablation of paravertebral facet joint nerves. CPT®* Codes

Description

64633†† Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, single facet joint

64634†† Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); cervical or thoracic, each additional facet joint (List separately in addition to code for primary procedure)

64635†† Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, single facet joint

64636†† Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar or sacral, each additional facet joint (List separately in addition to code for primary procedure)

††Note: Experimental/Investigational/Unproven/Not Covered when used to report cryoablation, cryoneurolysis, cryodenervation, chemical ablation, laser ablation, or endoscopic radiofrequency denervation/endoscopic dorsal ramus rhizotomy. ICD-9-CM Diagnosis Codes

Description

721.0 Cervical spondylosis without myelopathy 721.1 Cervical spondylosis with myelopathy 721.2 Thoracic spondlyosis without myelopathy 721.3 Lumbosacral spondylosis without myelopathy 721.41 Thoracic or lumbar spondylosis with myelopathy; thoracic region 721.42 Thoracic or lumbar spondylosis with myelopathy; lumbar region 722.81 Postlaminectomy syndrome; cervical region 722.82 Postlaminectomy syndrome; thoracic region 722.83 Postlaminectomy syndrome; lumbar region 723.1 Cervicalgia 723.8 Other syndromes affecting cervical region 723.9 Unspecified musculoskeletal disorders and symptoms referable to neck 724.1 Pain in thoracic spine 724.2 Lumbago 724.5 Backache, unspecified 724.6 Disorders of sacrum 724.70-724.79

Disorders of coccyx

724.8 Other symptoms referable to back 724.9 Other specified back disorders

ICD-10-CM Diagnosis Codes (Effective

Description

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10/01/2015) M43.8x9 Other specified deforming dorsopathies, site unspecified M47.011-M47.019 Anterior spinal artery compression syndromes M47.021-M47.029 Vertebral artery compression syndromes M47.11 Other spondylosis with myelopathy, occipito-atlanto-axial region M47.12 Other spondylosis with myelopathy, cervical region M47.13 Other spondylosis with myelopathy, cervicothoracic region M47.14 Other spondylosis with myelopathy, thoracic region M47.15 Other spondylosis with myelopathy, thoracolumbar region M47.16 Other spondylosis with myelopathy, lumbar region M47.21-M47.28 Other spondylosis with radiculopathy M47.811-M47.818 Spondylosis without myelopathy or radiculopathy M47.891-M47.898 Other spondylosis M53.2x7 Spinal instabilities, lumbosacral region M53.2x8 Spinal instabilities, sacral and sacrococcygeal region M53.3 Sacrococcygeal disorders, not elsewhere classified M53.80-M53.88 Other specified dorsopathies M53.9 Dorsopathy, unspecified M54.2 Cervicalgia M54.5 Low back pain M54.6 Pain in thoracic spine M54.81 Occipital neuralgia M54.89 Other dorsalgia M54.9 Dorsalgia, unspecified M96.1 Postlaminectomy syndrome, not elsewhere classified

Experimental/Investigational/Unproven/Not Covered: ICD-9-CM Diagnosis Codes

Description

All other codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All other codes Experimental/Investigational/Unproven/Not Covered when used to report sacroiliac (SI) joint nerve ablation by any method, or any procedure listed as such in this Coverage Policy including but not limited to dry needling of trigger points, cryoablation, cryoneurolysis, cryodenervation, chemical ablation, laser ablation, intradiscal steroid injection or endoscopic radiofrequency denervation/endoscopic dorsal ramus rhizotomy: CPT* Codes Description 22899 Unlisted procedure, spine 64640 Destruction by neurolytic agent; other peripheral nerve or branch 64999 Unlisted procedure, nervous system

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ICD-9-CM Diagnosis Codes

Description

All codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All codes Additional Procedures: Experimental/Investigational/Unproven/Not Covered: CPT* Codes Description 22526 Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral

including fluoroscopic guidance; single level 22527 Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral

including fluoroscopic guidance; 1 or more additional levels (List separately in addition to code for primary procedure)

62263 Percutaneous lysis of epidural adhesions using solution injection (e.g., hypertonic saline, enzyme) or mechanical means (e.g., catheter) including radiological localization (includes contrast when administered), multiple adhesiolysis sessions; 2 or more days

62264 Percutaneous lysis of epidural adhesions using solution injection (e.g., hypertonic saline, enzyme) or mechanical means (e.g., catheter) including radiological localization (includes contrast when administered), multiple adhesiolysis sessions; 1 day

62287 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with use of an endoscope, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbar

0274T

Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy) any method under indirect image guidance (eg, fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; cervical or thoracic

0275T Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy) any method under indirect image guidance (eg, fluoroscopic, CT), with or without the use of an endoscope, single or multiple levels, unilateral or bilateral; lumbar

HCPCS Codes

Description

C2614 Probe, percutaneous lumbar discectomy S2348 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral

disc, using radiofrequency energy, single or multiple levels, lumbar ICD-9-CM Diagnosis Codes

Description

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All codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All codes Experimental/Investigational/Unproven/Not Covered when used to report any procedure listed as such in this Coverage Policy including but not limited to endoscopic epidural adhesiolysis, epiduroscopy, epidural myeloscopy, epidural spinal endoscopy, percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), intradiscal radiofrequency thermomodulation, percutaneous radiofrequency thermomodulation, percutaneous spinal decompression (e.g., mild® procedure), or intervertebral disc biacuplasty/cooled radiofrequency: CPT* Codes Description 22899 Unlisted procedure, spine 64999 Unlisted procedure, nervous system

ICD-9-CM Diagnosis Codes

Description

All codes ICD-10-CM Diagnosis Codes (Effective 10/01/2015)

Description

All codes *Current Procedural Terminology (CPT®) ©2013 American Medical Association: Chicago, IL. References

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