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DAVID A. CHAPMAN-SMITH, LL.B (Hons) Barrister and Solicitor

1246 Yonge Street, Suite 203, Toronto, ON Canada M4N 3N1 Tel: 416-484-9601 Fax: 416-484-9665 E-mail: TCR@chiropracticreport.com

January 31, 2012

Item Page

A. A Study of Major Importance to Commence the Year: Neck Pain. ........................1 B. Acute Chest Pain: First Trial of Chiropractic Management.....................................5 C. Sports Chiropractic: Improving Grip Strength in Elite Judokas .............................8 D. UPMC Health Plan: Chronic LBP – New Requirement for Manipulation. ...........9 References Appendix Bronfort and Evans et al. paper – (Item A, p.1) ................................................................... A

Stochkendahl et al. paper – (Item B, p.5) ............................................................................... B

Haldeman and Chapman-Smith paper – (Item C, p.8)........................................................C

Botelho and Andrade paper – (Item C, p.8) ......................................................................... D

UPMC Health Plan letter to Providers – (Item D, p.9)…………………………………… E

UPMC Health Plan Policy and Procedure Manual – Extracts re Surgical Management of Low Back Pain. Policy Number MP.043 – (Item D, p.9) ......................... F

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DAVID A. CHAPMAN-SMITH, LL.B (Hons) Barrister and Solicitor

1246 Yonge Street, Suite 203, Toronto, ON Canada M4N 3N1: Tel: 416-484-9601 Fax: 416-484-9665 E-mail: TCR@chiropracticreport.com

January 31, 2012

A. A Study of Major Importance to Commence the Year: Neck Pain Reference:

Bronfort G, Evans R et al. (2012) Spinal Manipulation, Medication, or Home Exercise With Advice for Acute and Subacute Neck Pain. Ann Intern Med. 2012;156:1-10. (Appendix A)

1. Here from Gert Bronfort, DC, PhD, Roni Evans, DC, MS and colleagues at Northwestern Health Sciences University, Bloomington, Minnesota, is the most important research evidence for the chiropractic profession that you will see published this year. It was published in the January 3, 2012 issue of the Annals of Internal Medicine, the official journal of the American College of Physicians.

It provides the first compelling evidence that chiropractic spinal manipulation is superior to standard medical care for patients with acute and subacute mechanical neck pain. In a world where “no evidence-informed first-line therapy… has been established” for such neck pain patients, Brontfort et al. conclude that spinal manipulative therapy (SMT) and home exercises and advice (HEA) – which was also studied in this trial and proved superior to medical care – “ both constitute viable treatment options for managing acute and subacute mechanical neck pain.” (8/1/4 and bottom)

Reasons why this trial is so important to the profession include:

a) It is from an interdisciplinary team of established chiropractic and medical researchers and scientifically strong and unassailable.

b) It was funded by the US National Institutes of Health.

c) It was published in the Annals of Internal Medicine, and will therefore be much more broadly accepted within the medical profession. This also means that it was given much more publicity – in the week it was published it was the subject of reports on national TV networks in the US and in a major article in the New York Times titled Chiropractic, Exercise Better than Medication.

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d) It provides the first high-quality trial evidence of effectiveness of chiropractic SMT for patients with acute and subacute mechanical neck pain, and evidence that chiropractic SMT is significantly superior to standard medical care with medications. (Expect the pharmaceutical world to be upset and reacting to this.)

e) It entrenches Haldeman’s BJD 2000-2010 Neck Pain Task Force Report as the core study and classification of neck pain in the world literature.

f) Many medical doctors overreact to the issue of safety neck manipulation because of their fundamental belief that the treatment has no benefit anyway. Therefore why incur any risk. This trial, published in the Annals, radically changes that. Manipulation is effective for the great majority of patients with common mechanical neck pain. Therefore appropriateness must be judged through a balance of benefit and risk. Risk must be assessed on the real evidence rather than knee-jerk reaction.

On one hand this trial does show that HEA produces similar results at less cost, on the other hand chiropractic management produced higher patient satisfaction and raw results were even better for chiropractic than for HEA.

2. The paper begins by explaining how common and costly neck pain is, how commonly applied treatments are spinal manipulation, exercise programs and medications, all of which have inadequate trial evidence of effectiveness, and that the goal of this trial was “to determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term.” (1/Abstract)

3. Summary details of the trial:

a) Patients. These were 272 adults aged 18-65 years with acute or subacute mechanical neck pain (2-12 weeks duration) and neck pain of 3 or more on a scale of 0-10.(2/1/2&3) Most had subacute pain – more than 4 week. (8/1/3) These subjects were noted as having the equivalent of Grades I and II neck pain according to the BJD 2000-2010 Task Force on Neck Pain and its Associated Disorders.

Exclusion criteria included receiving any of the 3 study treatments during the past 3 months, and a number of complications or comorbidities.

b) Treatments. Patients were randomly assigned to 1 of 3 treatment groups:

i. SMT Group. Treatment was by 6 experienced chiropractors for a maximum of 12 weeks. Primary focus was “manipulation of areas of the spine with segmental hypomobility by using diversified techniques, including low-amplitude spinal adjustments and mobilization.” Spinal level and number of treatments were left to the discretion of the clinician. Adjunct therapy common to clinical

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practice was allowed – e.g. light soft-tissue massage, assisted stretching, hot and cold packs and advice on activity. (2/2/2)

In fact there was an average of 15 visits (range 2-23). (5/Table 2)

ii. Medication Group. Medical care in a pain clinic, with a first line of therapy of NSAIDS, acetaminophen or both, and with advice on activity. As needed narcotic medications and muscle relaxants were also used. Choice of medications and number of visits was at the discretion of the physician. (2/2/3) Average number of visits during the 12 week period was 5 (range 1-8). (5/Table 2)

iii. HEA Group. Home exercise with advice was provided in 2 one hour sessions by therapists at Northwestern outpatient clinics. “The primary focus was simple self-mobilization exercise (gentle controlled movement) of the neck and shoulder joints, including neck retraction, extension, flexion, rotation, lateral bending motions, and scapula retraction, with no resistance.” (2/2/bottom) See the paper for more details and pictures of the actual exercises (last 2 pages at end of paper)

c) Outcome Measures.

i. Primary measures of results were both subjective (pain levels on an 11-box numerical rating scale at baseline, 2, 4, 8 and 12 weeks during the treatment phase, and at 26 and 52 weeks (1 year follow up), and objective (cervical spine motion at 4 and 12 weeks measured by blinded examiners). (3/2/2 and 3)

ii. Secondary measures included the Neck Disability Index, global improvement, medication use, satisfaction of care, the Short Form-36 Health Survey (SF-36) and cervical spine motion (measured with a CA 6000 Analyzer). (3/1/3)

d) Results.

i. Overall results, as described in the abstract were that “for pain, SMT had a statistically significant advantage over medication after 8, 12, 26 and 52 weeks and HEA was superior to medication at 26 weeks. No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome”. (1/Abstract)

ii. See Table 3 for details of differences between the groups on pain. This includes figures of the number of patients with 50% or

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greater, 75% or greater or 100% reduction in pain at various time intervals. For example:

• At week 12, or the end of the treatment phase, there was a 100% reduction in pain (ie. complete recovery) in 32.2% of the SMT group patients, 29.9% of the HEA group patients and 13.1% of the medication group patients.

• Also at 12 weeks there was a 75% or greater reduction in pain in 56.7% of the SMT group, 48.3% of the HEA group and 33.3% of the medication group.

• At week 26 there was 100% reduction/complete recovery in 36.9% of the SMT group, 34.6% of the HEA group and 19.2% of the medication group.

iii. As noted in the abstract secondary outcome measures all supported the results of the primary pain outcome measures. Note one exception however. While the SMT and HEA groups performed similarly on most of the secondary outcome measurers “SMT performed better than HEA for satisfaction of care in both the short and long-term.” There are no further details in the paper. (6/1/2)

iv. Importantly, there were no serious adverse events reported from any of the treatments, just transient musculoskeletal discomfort from patients in the SMT group (40%) and HEA group (46%) and GI and other systemic symptoms in the medication group (60%).

4. Finally, in the discussion section at the end of the paper, Bronfort, Evans et al. note that there is no accepted definition of what constitutes clinically important differences between groups of subjects/patients in a trial, but suggest these factors or criteria:

• Statistically significant results as measured by primary and secondary outcome measures.

• The durability of treatment effect – i.e. are benefits sustained over time.

• The safety and tolerability of the interventions.

• The ability and willingness subjects/patients to adhere to treatment programs. (7/2/2)

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They maintain scientific objectivity in drawing conclusions, make no overt comment about the relative ineffectiveness of medical management, but do conclude following a short review of the existing evidence that “our results suggest that HMT and HEA both constitute viable treatment options for managing acute and subacute mechanical neck pain.”(8/1/bottom)

5. This trial of course, illustrates how chiropractic care addresses the cause of the problem not the symptoms. As one of the MD’s on the ABC Television clip observed, “You would expect chiropractic treatment or exercise to do better than medication because it addresses the mechanical problem”.

B. Acute Chest Pain: First Trial of Chiropractic Management

Reference:

Stochkendahl MJ, Christensen HW et al. (2011) Chiropractic Treatment vs Self-Management in Patients With Acute Chest Pain: A Randomized Controlled Trial of Patients Without Acute Coronary Syndrome, J Manipulative Physiol Ther 2012;35:7-17 (Appendix B)

1. The January issue of JMPT published the 4 award-winning original research

papers – all randomized controlled trials – from the World Federation of Chiropractic’s 11th Biennial Congress held in Rio de Janeiro last April. They include this first prize winning trial from Mette Stochkendahl, DC, PhD, Henrik Christensen, DC, MD, PhD et al. in Denmark – the first ever trial of chiropractic management of patients with chest pain suspected to be caused by heart disease or acute coronary syndrome (ACS).

The trial involved 115 patients referred by their family physicians to an emergency cardiology department at Odense University Hospital. Following medical screening to rule out ACS these patients were randomly assigned to 4 weeks chiropractic management or alternatively self-management after reassurance and advice on exercise. Both groups improved significantly at 4 weeks (end of intervention) and 12 weeks, however the chiropractic patients did significantly better and Stochkendahl, Christensen et al. report that their study suggests that “chiropractic treatment might at least lead to a faster recovery in patients with acute musculoskeletal chest pain.” (15/2/3) Stochkendahl, Christensen et al. report from the literature that “approximately 20% of admissions for suspected ACS” relate to patients without ACS who have undifferentiated chest pain and “leave emergency departments without a definite diagnosis or a plausible explanation for their pain.” In the US 12 years ago it was estimated that the cost for initial care for such patients was $8 billion.

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(8/1/1) They conclude that there are these good reasons for investigating offering chiropractic treatment to such patients:

• To minimize suffering and overall cost on these patients. • The scale of the problem in terms of the number of patients involved. • The documented consequences in daily life and repeated contact with

the health care system for those affected. • The limited cost of a short series of chiropractic treatment. • The challenge for general practitioners/family physicians of knowing

how to handle patients with non-cardiac chest pain after discharge from a cardiology unit. (15/2/4)

2. Some further details concerning the trial are:

a) Background. It comes from a chiropractic research team at the University of Southern Denmark that has developed a standardized evaluation protocol to identify patients with musculoskeletal chest pain among those with known or suspected stable angina, published in JMPT in 2005. This is the first of a planned series of treatment trials.

b) Patients. These were the 115 consecutive patients without ACS amongst

patients referred to a specialist cardiology unit by their family physicians. They were adults aged 18-75 years with a primary complaint of acute chest pain for less than 7 days duration. (8/1/bottom)

c) Intervention Groups. These were:

i. Chiropractic Treatment Group. Participants received 4 weeks chiropractic management as thought appropriate from 1 of 8 experienced chiropractors from their local community. Treatment had to include manipulation directed towards the thoracic and/or cervical spine with a maximum of 10 treatment sessions 1 to 3 times per week. Other manual treatments (e.g. joint mobilization, soft-tissue techniques) exercises, heat or cold treatment etc. could be given as felt necessary. ii. Self-Management Group. Each participant had a 15 minute consultation with reassurance that the chest pain was benign and self-limiting. The participant was given instruction regarding home exercises aimed at increasing spinal movement or muscle stretch. (9/1/2)

d) Outcome Measures and Results. The 2 primary outcome measures were change in pain intensity on an 11 –point numeric rating scale and self-

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perceived change in chest pain on a 7-point scale with responses from “much worse” to “much better” at 4 weeks and 12 weeks. Secondary outcome measures included 5 other measures of change in pain intensity as described in the paper. (9/1/bottom)

Results included : i. Chiropractic manipulation was most often directed towards the

mid-thoracic region and the lower cervical spine, with trigger point therapy and massage being the second most commonly used treatment modalities.

ii. There was significant improvement in both treatment groups,

part of which the authors acknowledge to have been the result of natural history and regression to the mean.

iii. However, there were quicker and better results in the

chiropractic treatment group, and these increased and reached statistical significance as time passed. For example for thoracic spine pain there was significant decrease in the chiropractic group of 12 weeks but not in the self-management group. At both 4 and 12 weeks the largest decrease in worst chest pain was seen the chiropractic treatment group, with this being statistically significant at 12 weeks. (11/1/bottom and 11/2/1&2) Stochkendahl, Christensen et al. point out that these group differences point to the superior effectiveness of chiropractic treatment and cannot be explained by natural history and regression toward the mean. (15/1/2)

iv. There were no serious adverse effects. (11/1/1)

3. Accordingly, here is another landmark trial for the profession. It should not be

over-interpreted. It suggests rather than proves the effectiveness of chiropractic management; however it shows the profession developing an assessment and treatment protocol of major potential significance in terms of reducing patient suffering and cost. It provided a compelling basis for similar inter-disciplinary research in other countries.

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C. Sports Chiropractic: Improving Grip Strength in Elite Judokas References:

Haldeman S and Chapman-Smith D (2011) Award-Winning Articles and Posters From the World Federation of Chiropractic’s 11th Biennial Congress 2011 , J Manipulative Physiol Ther 2012;35:2-6. (Appendix C)

Botelho MB and Andrade BB (2011) Effect of Cervical Spine Manipulative Therapy on Judo Athletes’ Grip Strength; J Manipulative Physiol Ther 2012;35:38-44. (Appendix D)

1. The attached editorial by Dr Scott Haldeman and me has photographs of Dr Stochkendahl presenting her research and receiving her award, and a list of all prize-winning research papers not only in Rio de Janeiro but since 1991. The one other paper I now attach won the Private Practice award at the Rio Congress – it is from Brazilian chiropractor Marcelo Botelho, DC, and titled Effect of Cervical Spine Manipulative Therapy on Judo Athletes’ Grip Strength.

2. This is valuable because there is relatively little research showing the value of chiropractic manipulation in improving function in athletic performance in asymptomatic elite athletes. Here is a pilot randomized controlled trial showing chiropractic cervical spine manipulation significantly increasing grip strength in elite judokas. Points are:

a) Patients. Patients were 18 national level judo athletes aged 15-30 years with no prior chiropractic care. (39/2/3)

b) Interventions. They were randomly assigned into 2 groups of 9 being:

i. Cervical SMT Group. In a period of 3 weeks they received “standard chiropractic cervical diversified technique SMT” on 3 occasions at least 36 hours apart. This was directed at “areas of motion restriction” elicited by static and motion palpation. The most commonly affected joints were C1 and C2 (49% of the 55 cervical adjustments). (39/2/4 and 40/2/2)

ii. Sham Group. Within the same time frame these patients received 3 sham interventions. These consisted of the patient lying prone on a table with a drop mechanism which was activated 3 – 5 consecutive times with the chiropractor applying contact force to the table not the patient. (39/2/bottom)

c) Outcome Measures and Results. The outcome measure was maximum isometric grip contraction strength at least 20 seconds after

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each intervention as measured by a hydraulic dynamometer more fully described in the paper. (40/1/3) After each intervention, grip strength was measured 3 times by a technician blinded to which intervention had been received, and then averaged. Results were:

i. There was a statistically significant increase in grip strength in both the left and right hands after each intervention in the chiropractic SMT group but no such increases within the sham group.

ii. In the chiropractic SMT group there was a cumulative effect. After the first intervention the increase in grip strength was 6.95% right, 12.61% left. After the second intervention the increases were 11.53% right, 17.02% left. That improvement was basically maintained after the third intervention – 10.53% right, 16.81% left. (38/abstract and 41/1/bottom)

In summary, here are elite strength and combat athletes recording a highly significant increase in grip strength after chiropractic cervical adjustment to correct biomechanical restrictions in the cervical spine. Botelho and Andrade list the various nerves and muscles they consider likely affected by the treatment given. (42/2/bottom) D. UPMC Health Plan: Chronic LBP – New Requirement for

Manipulation.

References:

UPMC Health Plan letter to Providers. (2012) (Appendix E) UPMC Health Plan Policy and Procedure Manual – Extracts re Surgical Management of Low Back Pain. Policy Number MP.043 (2011) (Appendix F)

1. Remember when it was the medical view that spinal manipulation was ineffective and inappropriate for patients with chronic low-back pain? As of January 1, 2012 United Pennsylvania Medical Care (UPMC) Health Plan has a policy requiring that a patient has tried and failed a 3 month course of conservative management specifically requiring “early referral to a chiropractor or physical therapist” for treatment that includes manipulation/mobilization, if

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advanced imaging or any surgical procedure is to be authorized and reimbursed. I attach:

a) The undated letter in late 2011 from UPMC Health Plan’s senior medical director to Providers advising this new policy.

b) The 6 page policy itself – which can also be found online at www.upmchealthplan.com.

2. Chronic LBP is defined as “low-back pain or sciatica that is present for more than 3 months” (UPMC Policy Page 1) The 3 months of conservative management must include non-pharmacologic therapy (including advice on self-care, screening for yellow flags, patient enrollment and graduation from a low back pain program), pharmacologic therapy and “early referral to a chiropractor or physical therapist for manipulation/mobilization, stabilization exercises, directional preference strategies and/or traction”. (Policy page 3)

3. Two key issues of interest emerge from all of this:

• Express reference to chiropractic management as a pre-requisite for approval of spinal surgery.

• However, apparent equivalence given to chiropractic and physical therapy in a jurisdiction in which physical therapists are licensed to use spinal manipulation, (in some US states they are not).

From inquiries made so far I understand this is the first major health plan to adopt such a policy with express reference to chiropractic care. This should be a valuable precedent entering other jurisdictions. At the end of the policy see the various published guidelines upon which this new policy is based.