July 18 - 21, 2019The Diplomat Hotel, Hollywood, FL

Interventional Pain Management

2019

The Florida Society of Interventional Pain Physicians

and the

Florida Society of Physical Medicine and Rehabilitation

Present

EDUCATIONAL GUIDE

FSIPP/FSPM&R 2019 July 18-21st 2019 at the Diplomat Beach Resort Hollywood, FL

This educational activity has been a Joint Collaboration between and the Florida Society of Interventional Pain Physicians (FSIPP) and the Florida Society of Physical Medicine and Rehabilitation Physicians (FSPM&R) with Intended Audience

FSIPP/FSPM&R 2019 will feature an interventional pain medicine faculty, some nationally and internationally recognized. This content led conference will help the interventional pain medicine practitioner expand and update existing knowledge/skills regarding ever-increasingly sophisticated diagnostic and practice guidelines, to share new ideas for evaluation and treatment within the current medical legislative and regulatory environment. Educational formats include: lectures, powerpoint presentations, panel discussions and question and answer time built into every presentation for audience participation and learning.

Learning Objectives Upon completion of this activity, the participant should be able to:

• Recognize and evaluate pain, description of pain, and pain markers • Interpret new Federal Regulations to assist in implementing standards of care and to assist in patient and

compliance • Achieve a greater understanding of best practices and available guidelines on new techniques, agents and

therapies for patients.

Statement of Need Pain management and Interventional pain management are quickly growing fields in medicine. Emerging science and treatment options for patient care are growing rapidly and it is important for clinicians specializing in this field of medicine to know, understand and evaluate available options to be able to continue to provide the best treatment options and quality of care for patients. Additionally, this field of medicine is subject to higher than normal scrutiny, liability and litigiousness stemming from alleged over treatment and under treatment of care. It is vitally important for clinicians to understand best practices and practice guidelines to insure that they are offering the best care, remaining in compliance to lessen exposure and liability while still insuring access to care and the best treatment outcomes for patients. Accreditation Statement(s)

In support of improving patient care, this activity has been planned and implemented by Dannemiller and FSIPP/FSPM&R. Dannemiller is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Physicians Dannemiller designates this live activity for a maximum of 22.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Registered Nurses Dannemiller designates this educational activity for 22.0 CE contact hours. Nurse Practitioners Dannemiller is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 090419. This program is accredited for 22.0 contact hour(s) which includes 9.5 hours of pharmacology.

Method of Participation Participants should first read the objectives and other introductory CME/CE information and then proceed to the educational activity. To receive credit for this activity, www.dannemiller.com/activity/1876. Credit is provided through 8/31/19. No credit will be given after this date.

In the event you have questions about this activity or are unable to retrieve the certificate, please e-mail cme@dannemiller.com and a certificate will be emailed within 2 weeks.

Faculty Dave Albaneze Ramsin Benyamin, MD Maulik Bhalani, MD Jennifer Bolen, JD Randall Braddom, MD Lorrie Brown, MD Jeff Buchalter, MD Jorge Caceres, MD Aaron Calodney, MD Ken Candido, MD Harold Cordner, MD Michael Creamer, DO Harold Dalton, DO Miguel De la Garza, MD Oscar DePaz, MD Sandeep Dhanjal, MD Sudhir Diwan, MD Daniel Duncanson, MD Richard Epter, MD Michael Esposito, MD

Steven Falowski, MD Roger Fillingim, PhD Orlando Florete, MD Vincent Galan, MD, MBA, DAPBM Vidur Ghantiwala, DO Christopher Gharibo, MD Stanley Golovac, MD Scott Griffith, MD Jeffrey Gudin, MD Hans Hansen, MD Kazi Hassan, MD Carl “Fritz” Hayes, MD Matthew Imfeld, MD Jon Johnson, MD Nick Knezevic, MD, PhD Sean Li, MD Craig Lichtblau, MD Jesse Lipnick, MD

Nagy Mekhail, MD,PhD Quang Nguyen, MD Steve Passik, MD Trevor Persaud, DO Jason Pope, MD Rene Przkor, MD Rosa Rodriguez, MD Elizabeth Shaw, JD Sanford Silverman, MD Douglas Spiel, MD Peter Staats, MD, MBA Carrie Steichen, DO Cliff Swezey, Ed.D Deborah Tracy, MD Andrea Trescot, MD Richard Tucker MD Ricardo Vallejo, MD, PhD Krystal Yankowski, DO Jeffrey Zuckerman, MD

Disclosures

In accordance with the Accreditation Council for Continuing Medical Education (ACCME), Dannemiller requires that any person who is in a position to control the content of a CME/CE activity must disclose all financial relationships they have with a commercial interest. The following faculty stated they have no financial relationships with commercial interests:

Dave Albaneze , Maulik Bhalani, MD, Randall Braddom, MD, Lorrie Brown, MD Jeff Buchalter, MD, Jorge Caceres, MD, Ken Candido, MD, Michael Creamer, DO, Harold Dalton, DO, Oscar DePaz, MD, Sandeep Dhanjal, MD, Richard Epter, MD, Roger Fillingim, PhD, Orlando Florete, MD, Vidur Ghantiwala, DO, Stanley Golovac, MD, Scott Griffith, MD, Kazi Hassan, MD, Carl “Fritz” Hayes, MD, Matthew Imfeld, MD, Jon Johnson, MD, Nick Knezevic, MD, PhD, Craig Lichtblau, MD, Jesse Lipnick, MD, Trevor Persaud, DO, Rene Przkora, MD, Rosa Rodriguez, MD, Elizabeth Shaw, JD, Carrie Steichen, DO, Cliff Swezey, Ed.D, Deborah Tracy, MD, Krystal Yankowski, DO, Jeffrey Zuckerman, MD

The following faculty members have financial relationships with commercial interests:

● Ramsin Benyamin, MD- Consultant: Avanos, Vertiflex ● Jennifer Bolen, JD- Consultant: Paradigm Healthcare. Advisory/Medical Board: Paradigm Healthcare. ● Aaron Calodney, MD- Speakers Bureau: Nevro, Stimwave, Stryker. Investigator: Medtronic ● Harold Cordner, MD- Speakers Bureau: Nuvectra

● Miguel De la Garza, MD- Speakers Bureau: Collegium, Pfizer, Boston Scientific. ● Consultant: Pfizer. Advisory/Medical Board: Collegium ● Sudhir Diwan, MD- Speakers Bureau: Apex Biologixx, Cornerloc. Advisory/Medical Board: Cornerloc, Boston Scientific,

Vertos ● Daniel Duncanson, MD, CEO SIMEDHealth- ● Michael Esposito, MD- Speakers Bureau: Abbott, Flowonix, Vertiflex. Consultant: Abbott, Flowonix, Vertiflex, Boston

Scientific. Advisory/Medical Board: Flowonix, Vertiflex, Boston Scientific. Investigator: Abbott. ● Steven Falowski, MD- Speakers Bureau: Abbott, Saluda, Vertiflex. Consultant: Abbott, Saluda, Medtronic, SPR, Vertiflex.

Advisory/Medical Board: Abbott, Saluda, SPR, Vertiflex. Investigator: Abbott, Saluda, Medtronic. Stockholder: Saluda, SPR, Stimgenics.

● Vincent Galan, MD, MBA, DAPBM- Investigator: Nevro, Medtronic, Neuros ● Christopher Gharibo, MD- Speakers Bureau: Bayer. Consultant: Recro, Pernix, DSI, Astra Zeneca. ● Jeffrey Gudin, MD- Speakers Bureau: DSI, Salix, Scilex. Consultant: BDSI, DSI, Kempharm, Scilex, Quest Diagnostics.

Advisory/Medical Board: BDSI, DSI, Salix, Scilex. ● Hans Hansen, MD- Stockholder: Pfizer ● Sean Li, MD- Speakers Bureau: Nevro, Vertiflex, SI Bone, Avanos, Saluda. Consultant: Nevro, Vertiflex, SI Bone, Avanos,

Saluda. Advisory/Medical Board: Nevro, Vertiflex, Avanos, Saluda. Investigator: Nevro, Vertiflex, Avanos, SPR, Saluda. Stockholder: Nevro.

● Nagy Mekhail, MD,PhD- Consultant: Flowonix, Nuvectra, Saluda, Vertos, Nevro. Advisory/Medical Board: Boston Scientific, Nuvectra.

● Quang Nguyen, MD - Speakers Bureau: Nevro. Consultant: Nevro. Investigator: Nevro, Gruenthal, Vertos ● Steve Passik, MD- Company Employee: Collegium Pharmaceuticals ● Jason Pope, MD- Advisory/Medical Board: Abbott, Saluda, Vertiflex, Vertos, Flowonix ● Sanford Silverman, MD- Speakers Bureau: DSI ● Douglas Spiel, MD- Stockholder: Kimera Labs ● Peter Staats, MD, MBA- Consultant: Electrocore, SPR Therapeutics, Nalu. Investigator: Saluda, Nalu. Stockholder:

Electrocore, SPR Therapeutics. Company Employee: National Spine. ● Andrea Trescot, MD- Company Employee: Stimwave ● Richard Tucker, DEA-Speakers Bureau: Precision Diagnostics.

● Ricardo Vallejo, MD- Speakers Bureau: Halyard, Medtronic. Company Employee: StimGenics

Jesse Lipnick, MD, content reviewer and Jennifer Hodge Dannemiller project manager have no financial relationships with commercial interests.

To resolve identified/potential conflicts of interest, the educational content was fully reviewed by a member of the Dannemiller Clinical Content Review Committee who has nothing to disclose. The resulting certified activity was found to provide educational content that is current, evidence based and commercially balanced.

Off-label statement Off label statement provided: This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by FDA. The opinions expressed in the educational activity are those of the faculty. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings. Further, attendees/participants should appraise the information presented critically and are encouraged to consult appropriate resources for any product or device mentioned in this program.

Disclaimer The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Dannemiller, FSIPP or FSPM&R. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject.

FSIPP Abstract Guide

Association of High Grade Type I Modic Changes in Patients with Severe Lower Back Pain: Case Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Opioid Use in Immunocompromised Patients and the Increased Likelihood of Post-Surgical Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Efficacy of Bilateral Intra-articular CNTX-4975 Injection for Management of Painful Knee Osteoarthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Assessment of cooling methods for reducing procedural pain associated with CNTX-4975 injection for management of painful knee osteoarthritis . . . . . . . . . . . . . . . . . . . . . . . . 8

Defining the therapeutic window for spinal cord stimulation using evoked compound action potential (ECAP) recordings— results from the Evoke study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Long-term results from feedback-controlled spinal cord stimulation using evoked compound action potentials (Avalon study) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Evoked compound action potentials to guide lead placement: a neuromonitoring technique—case series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Automated, routine monitoring of neurophysiological parameters in spinal cord stimulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Posterior Sacroiliac Fusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Outcomes Using an SCS Device Capable of Delivering Combination Therapy and Advanced Wave-forms/Field Shapes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

WHISPER RCT: AN UPDATED POST-HOC EVALUATION OF SUB-PERCEPTION SCS AT ≤1 .2 KHZ IN PREVIOUSLY-IMPLANTED SUBJECTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Exploration of High and Low Frequency Options for Sub-Perception Pain Relief: The HALO Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Outcomes Following Utilization of a Device Adaptor in Previously-Implanted Patients Using SCS For Chronic Pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

A Prospective Global Registry of Real-World Outcomes Using Spinal Cord Stimulation Systems for Chronic Pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Association of High Grade Type I Modic Changes in Patients with Severe Lower Back Pain: Case Series

Giuffrida, Anthony; Srinivas Mallempati; Bradly GoodmanAlabama Orthopedic Spine and Sport Medical Associates

Abstract:Introduction:Lower back pain is the leading cause of disability worldwide. One cause for lower back pain is pain generated the vertebral endplate/ disc interface. Discogenic/endplate mediated pain is mostly due to degeneration of the disc and degeneration at the disc-vertebral endplate junction. This degeneration causes MRI signal changes which can be seen in the adjacent vertebral endplates. These signal changes are known as Modic changes.

Methods: We retrospectively collected data from ten consecutive patients who were diagnosed with high grade Modic Type I changes and subsequently underwent an intradiscal steroid injection (IDSI) at the affected level. We quantified their pain pre and post injection using the visual analog scale with a self-reported numerical rating from 1-10. Before proceeding with the IDSI we verified that the cause of the patient’s pain was not infectious in nature by ordering ESR, CRP and CBC. We then proceeded with an IDSI containing 1 cc betamethasone and 2 cc marcaine.

Results: Of the ten patients five were female and five were male with an average age of 69 years old. Two of these patients underwent confirmatory biopsies with both returning negative results for infection. Average time to follow up from day of procedure was 17 days. Average initial VAS score was 7.4 and average post injection VAS was found to be 4.2. There were no patients who reported worsening of their pain and no complications of infection, bleeding or neurologic dysfunction were reported.

Conclusion: Based on this case series we would recommend proceeding with IDSI in patient with axial back pain, low clinical concern for discitis, and MRI findings consistent with high grade type I Modic changes. If further confirmatory data is needed one could consider obtaining an infectious lab workup and/or performing a disc biopsy at the affected level.

Opioid Use in Immunocompromised Patients and the Increased Likelihood ofPost-Surgical Infection

Lauren Cuénant, George Ettel III, and Gabrielle McDermott

Introduction: While HIV patients with a CD4 count below 500 are known to have a compromised immune system, the use of opiates have also been associated with a decreased innate and adaptive immune response (1). HIV patients have chronic pain, soone-fourth of HIV patients have become addicted to opiates, and negatively impacting their immune system. Avoiding chronic use of opiates in HIV patients, undergoing surgery may reduce the occurrence of delayed wound healing, dehiscence, and post-operative infection. Materials and Methods: A 58 year-old African American female with a past medical history of right knee arthroplasty in 2018, gastric bypass in 2001, morbid obesity, HIV infection, osteoarthritis, anemia of chronic disease, and chronic bilateral lowerextremity lymphedema presents with fever, pain and purulent drainage from her right knee. Results: Right knee X-ray revealed cellulitis. CT guided drainage extracted 20mL of yellow exudate. The patient was placed on IV vancomycin and zosyn. Blood cultures were negative and wound cultures were positive for methicillin-susceptible staphylococcus aureus. The patient was instructed to resume antiretroviral therapy following discharge and consult with dietician for weight loss and lifestyle management. Conclusions: A number of factors contributed to this patient’s history of poor wound healing and dehiscence. Morbid obesity and a CD4 count below 400 put the patient at an increased risk for infection. However, long-term concomitant use of Morphine and Percocet likely furthered her immunocompromised state and poor wound healing. Therefore, it is arguable that non-opiate pain management options should be encouraged in immunocompromised patients to decrease rates of post-surgical infection.

References:Noel RJ Jr, Rivera-Amill V, Buch S, Kumar A. Opiates, immune system, acquired immunodeficiency syndrome, and nonhuman primate model. J Neurovirol. 2008;14(4):279–285. doi:10.1080/13550280802078209

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Efficacy of Bilateral Intra-articular CNTX-4975 Injection for Management of Painful Knee Osteoarthritis

Randall M. Stevens, MD,1 Kimberly Guedes, RN, BSN,1 Nilam Mistry, BS,1 Paul Tiseo, PhD,1 B. Duncan X. Lascelles, BVSc, PhD,2 James N. Campbell, MD,1 Mario R. Mendoza, MD, MS,1 David Ball, MBBS3 1Centrexion Therapeutics Corp., Boston, MA, USA; 2Translational Research in Pain, North Carolina State University, Raleigh, NC; 3MAC Clinical Research, Manchester, UK ABSTRACT:

Introduction: A double-blind, randomized, placebo-controlled trial (TRIUMPH; NCT02558439) with a single 1.0-mg intra-articular injection of CNTX-4975 (highly purified trans-capsaicin) into an index knee for management of moderate to severe knee osteoarthritis pain resulted in a statistically significant decrease in pain with walking vs placebo through 24 weeks post-dose. Here we present efficacy outcomes determined 6 weeks after bilateral osteoarthritic knee injections from a subsequent open-label clinical study (NCT03472677) of a prefilled syringe aqueous formulation of CNTX-4975. Materials and Methods: Subjects with bilateral moderate to severe painful knee osteoarthritis for ≥3 months before study entry received a single intra-articular CNTX-4975 1.0 mg injection into each knee, with 7 (±2) days between injections. Intra-articular lidocaine 2% (without epinephrine, 15 mL) was given 3–30 minutes before CNTX-4975 injection. Before lidocaine injection, and throughout the procedure, the intra-articular space was cooled using different techniques. Temperature changes in the joint were documented with an intra-articular probe. Pain with walking over the past 24 hours was rated on a Numeric Rating Scale (0–10) at baseline (4–9/10 inclusive required for enrollment) and at the end of the trial at 6 weeks for both knees. Results: Ten subjects (8 male, 2 female) with bilateral knee osteoarthritis were enrolled (mean age, 59 years). Baseline pain scores were averaged across both knees and ranged from 4 to 8 (Table). Mean pain with walking scores decreased from 5.9 at baseline to 1.6 at day 42, for a 73% pain reduction (P<0.001, 2-tailed, paired t test). Of the 10 subjects, 7 reported a pain level ≤2, and 3 reported no pain in either knee 5–6 weeks post-injection. Conclusions: Pain reduction following bilateral CNTX-4975 1.0 mg injection into painful osteoarthritic knees was statistically significant and consistent with that reported in the TRIUMPH study. Funding provided by Centrexion Therapeutics Corp.

Subject Pain With Walking Over 24 Hours by Knee at Baseline and After CNTX-4975 Injection at End of Trial

Numeric Rating Scalea

Left Knee Right Knee

Subject Baseline Day 42 Baseline Day 42

1011 8 2 7 2

1012 6 1 7 3

1013 7 0 6 0

1014 5 2 5 2

1015 6 0 6 0

1016 5 0 4 1

1017 5 0 6 0

1018 7 4 9 5

7

1019 5 2 5 2

1020 5 3 4 2

a0–10 rating scale; 0=no pain, 10=most severe pain imaginable.

Assessment of cooling methods for reducing procedural pain associated with CNTX-4975 injection for management of painful knee osteoarthritis

Randall M. Stevens, MD,1 Kimberly Guedes, RN, BSN,1 Nilam Mistry, BS,1 Paul Tiseo, PhD,1 B. Duncan X.Lascelles, BVSc, PhD,2 James N. Campbell, MD,1 Mario R. Mendoza, MD, MS,1 David Ball, MBBS3

1Centrexion Therapeutics Corp, Boston, MA; 2Translational Research in Pain Program, North Carolina StateUniversity, Raleigh, NC; 3MAC Clinical Research, Manchester, UK

ABSTRACT:Introduction: CNTX-4975, a trans-capsaicin intra-articular injection in phase 3 trials for treatment of moderate to severe pain associated with knee osteoarthritis, produces short-term procedural pain that can be attenuated with preemptive joint cooling. In a clinical study (NCT03472677; cohort 2), a circumferential circulating ice-water wrap more effectively lowered intra-articular knee temperature and reduced procedural pain compared with an ice pack on the knee. We enrolled cohorts 3 and 4 (C3/C4) to compare effects of 1) circumferential cooling methods (circulating ice-water vs ice-gel pack wraps) on intra-articular and skin knee temperature (C3); and 2) an abbreviated cooling schedule with vs without post–intra-articular CNTX-4975 cooling. (C4).

Materials and Methods: Subjects (aged 45–75 years) with bilateral moderate to severe osteoarthritis knee pain ≥3 months received each cooling device on opposite knees; injections/procedures on the left/right knees were separated by 7 (±2) days. See Figure for study design. Intra-articular and skin temperatures were recorded throughout procedures.

Results: Five subjects enrolled in/completed each cohort (mean age, yrs: C3, 57.6; C4, 59.6). In both cohorts, temperatures decreased with both methods; mean intra-articular temperatures at baseline/105 minutes: 33.7°C/26.7°C for ice-gel pack; 32.4°C/28.2°C for ice-water wrap; mean skin temperatures: 28.8°C/14.3°C, ice-gel pack; 28.7°C/15.2°C, ice-water wrap. In C4, mean intra-articular temperatures at baseline/55 minutes (15 minutes post-CNTX-4975 and/or end of last cooling period) were 33.6°C/29.0°C, ice-gel pack; 32.1°C/27.7°C, ice-water wrap; mean skin temperatures: 28.5°C/22.8°C, ice-gel pack; 27.8°C/18.8°C, ice-water wrap. Procedural pain peaked 10‒20minutes post-CNTX-4975 injection. While mean pain levels were similar across cohorts (Table), pain tended to be less under conditions of the ice-water wrap in C3 and ice-gel pack in C4. Absence of post-injection cooling in C4 was not associated with increased procedural pain.

Conclusions: Both ice-water wrap and ice-gel pack cooling methods effectively reduced knee joint temperatures. Funding provided by Centrexion Therapeutics Corp.Effect of Cooling on Procedural Pain

Procedural Pain Over Time (min), Mean±SEa Cohort 3 Cohort 4

Ice-gel pack Ice-water wrap Ice-gel pack Ice-water wrap

Baseline 0.8±0.37 0.4±0.24 0.4±0.24 0.2±0.20

10b 4.2±1.36 2.2±1.46 2.4±1.29 4.2±1.20

20b 3.6±1.33 2.2±1.20 3.0±1.22 2.6±1.25

30b 2.6±0.81 2.2±0.97 2.0±1.05 1.8±1.11

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Last assessmentc 2.4±0.81 1.4±0.40 1.6±1.03 2.4±1.60

Cohort 3: Comparison of 2 circumferential cooling methods; Cohort 4: Shortened cooling and with/without post-CNTX-4975cooling.

aLower scores=less pain; 0=no pain, 10=severe pain. bPost-CNTX-4975 injection; cApproximately 70 min post-injection for Cohort 3; 60 min for Cohort 4.

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Defining the therapeutic window for spinal cord stimulation using evoked compound action potential (ECAP) recordings—results from the Evoke study

Sean Li, MD; on behalf of the Evoke Study Investigators Premier Pain Centers, Shrewsbury, NJ

Introduction: Spinal cord stimulation (SCS) is an established treatment for chronic pain; however, long-term success remains suboptimal.1,2 Current SCS therapies are fixed-output and do not account for large variation in electrical field strength due to changes in distance between the electrode and SC.3 We report data from two prospective studies: Evoke and Avalon. Materials and Methods: In Avalon, 50 subjects were implanted and programmed in closed-loop; in Evoke, 134 subjects were randomized into open-loop (OL-SCS) or closed-loop (CL-SCS). ECAPs, a measure of SC activation, are recorded following each stimulation pulse in both groups (Figure 1). Each subject’s therapeutic window (TW) is determined individually as the ECAP amplitude range between sensation perception threshold and discomfort. Without measure of SC activation (eg, ECAPs), TW can only be based on perception of intensity; however, stimulation can produce variable SC activation (ECAP amplitude) as the electrode to SC distance varies with movement (Figure 2). Results: In Evoke, each subjects’ TW was determined in the clinic, along with the clinician prescribed level. There was no statistical difference between the two groups’ TWs (Figure 3); however, CL-SCS subjects spent significantly more time in the TW despite having equivalent therapeutic ranges (Figure 4). Long-term data showed similar percentages of stimuli in the TW (83%-97%; Figure 5). Conclusion: TW can be individually defined by ECAP amplitudes (measure of SC activation), removing the need to rely on subjective reports of intensity, which can vary over time and with movement.

Acknowledgements: This study was funded by Saluda Medical Pty Ltd.

References 1. Shealy CN, et al. Anesth Analg. 1967;46:489–491. 2. Van Buyten JP, et al. Neuromodulation. 2017;20(7):642–649. 3. Ranger MRB, et al. Br J Anaesth. 2008;101:804–809.

Fig. 1: Schematic representation of an ECAP.

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Fig. 2: SC activation plots – human data from the Evoke Study in 3 postures.

Fig. 3: SC activation plot from Evoke; shows parts of TW (perception to discomfort) for 3 postures.

Fig. 4: Comparison of CL-SCS (investigational) and OL-SCS (control) in Evoke at 3 months.

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Fig. 5: Median % stimuli below, within, and above the TW (3-mo to 12-mo visits) in Avalon. Disclosures SL reports serving as a consultant for Halyard Health, Medtronic, Nevro, SI-Bone, and Suture Concepts; receiving a research grant from SPR; and serving on the speakers’ bureau for Depomed.

Long-term results from feedback-controlled spinal cord stimulation using evoked compound action potentials (Avalon study)

Sean Li, MD; on behalf of the Avalon Study InvestigatorsPremier Pain Centers, Shrewsbury, NJ

Introduction: Currently marketed spinal cord stimulation (SCS) systems operate in a fixed-output stimulation configuration without sensing or adjusting to the nerves’ response (open-loop). A new SCS system uses evoked compound action potential (ECAP) to automatically adjust the stimulation current to maintain consistent SC activation (closed-loop). This prospective, multi-center, single-arm study was designed to demonstrate the safety and performance of closed-loop SCS system.

Materials and Methods: Seventy subjects with chronic pain were enrolled. Fifty subjects were implanted with a closed-loop SCS system (ACTRN12615000713594). Post-implantation subjects were followed over 12 months to assess therapy effectiveness and safety.

Results: At 12 months, back pain was reduced from 81.3 mm (± 1.4) to 22.7 mm (± 4.1) and overall pain was reduced to 21.0 mm (±3.4) from 81.3 mm (± 1.6). Leg pain responded similarly well to the therapy (Table). At 12 months, 83.7% of subjects reported significant, favorable change as described via Patient Global Impression of Change and 88.4% of subjects were “satisfied” or “very satisfied” with their treatment (Table). At baseline, 18.0% of subjects were minimally or moderately disabled on the Oswestry Disability Index; at 12 months, this proportion increased to 74.4% (Table).

Conclusions: The study to date has demonstrated sustained high rates of Visual Analogue Scale pain reduction through 12 months. We postulate that the stable level of SC activation is the main factor contributing to achieving this profound level of pain relief. This study continues to monitor the outcomes for subjects through a 2-year follow-up period.

Acknowledgements: This study was funded by Saluda Medical Pty Ltd.

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DisclosuresSL reports serving as a consultant for Halyard Health, Medtronic, Nevro, SI-Bone, and Suture Concepts; receiving a research grant from SPR; and serving on the speakers’ bureau for Depomed.

Evoked compound action potentials to guide lead placement: a neuromonitoring technique—case series

Steven M. Falowski, MD1; Milan Obradovic, MBiomedE2

1Neurosurgical Associates of Lancaster, Lancaster, PA; 2Saluda Medical, Sydney, Australia

Introduction: The procedure to place leads for spinal cord stimulation (SCS) traditionally required patients to be awake for reporting of device-induced paresthesias. Conversely, neuromonitoring using electromyography (EMG) recording determines optimal lead location while the patient is under general anesthesia. These techniques have been compared with regards to safety and efficacy, favoring the use of neuromonitoring.1,2

Objective: To present 7 subjects, incorporating the use of Evoked Compound Action Potential (ECAP) recording from implanted electrodes, using a new SCS system, and comparing the results with EMG recording.

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Material and Methods: Standard neuromonitoring protocols were employed at 2 institutions. Once leads were implanted, stimulation current was increased until the following were observed: ECAP and EMG signal (late response [LR]) on the implanted leads, and EMG signal on the neuromonitoring EMG electrodes. An x-ray was obtained; postoperative paresthesia testing was performed to assess paresthesia coverage at different points along the implanted leads.

Results: Data were obtained from 7 patients, across 2 sites. Onset of EMG signals on implanted electrodes and EMG electrodes correlated. Furthermore, the ratio of current amplitude between EMG onset and ECAP onset (LR:ECAP), on implanted leads, provides a potential estimate of lead laterality and objective lead placement; whereby a ratio <1 indicates leads are too lateral. This technique was used successfully to place leads under general anesthesia (1 case), without utilizing EMG recording as a dermatomal coverage marker.

Conclusions: Intraoperative recording of ECAPs and EMG signals from implanted leads may facilitate optimized lead placement, without requiring additional equipment and setup. Analysis of ECAP morphology and its relationship with different waveforms could have intraoperative diagnostic capabilities. It could be interesting to repeat recent work showing the effect of different waveforms on EMG recording3 with the addition of ECAP recording.

Acknowledgements: Supported by Saluda Medical Pty Ltd.

References1. Neuromodulation. 2012;14:130-135.2. Neurosurgery. 2018. doi:10.1093/neuros/nyy062.3. Neuromodulation. 2018. doi:10.1111/ner.12781

DisclosuresSMF reports serving as a consultant for Abbott, Medtronic, Nevro, Saluda, SPR, and Vertiflex; and conducting research for Abbott, Medtronic, Nuvectra, and Saluda.MO reports being an employee of Saluda Medical Pty. Ltd.

Automated, routine monitoring of neurophysiological parameters in spinal cord stimulation

Steven M. Falowski, MD1; Abeer Khurram, MS2

1Neurosurgical Associates of Lancaster, Lancaster, PA; 2Saluda Medical, Sydney, Australia

Introduction: Current spinal cord stimulation (SCS) systems provide no information to clinicians about the state of the spinal cord nerves being stimulated.

Objective: A new SCS system can record evoked compound action potentials (ECAPs) to measure neurophysiological parameters of the stimulated nerves.

Materials and Methods: Conduction velocity (CV), chronaxie, and rheobase were measured in chronic pain subjects implanted with a closed-loop SCS system as part of the Avalon study (Neuromodulation. 2018;21:38-47). Automated methods of collecting these data were introduced to collect data more quickly and efficiently during patient visits. Automated CV measurement involved setting the stimulation to a comfortable level and automatically scanning the measurement electrode along the lead, detecting ECAP peaks. Automated strength-duration curve measurement involved automatically varying current at different pulse widths and using ECAPs to determine the threshold for activation.

Results: Automated data collection methods were validated against manual methods to ensure that there were no differences between methods (Figure 1A). At the time of submission, 267 CV measurements were obtained in 39 patients, with a mean of 61±13m/s (Figure 1B). Mean chronaxie was 359±148µs and rheobase was 3.3±1.5mA from 77 strength-duration curves measured in 34 patients (Figures 1C and 1D). The CV was within the reported range of 16-100m/s for Aβ sensory fibers. Chronaxie and rheobase were comparable to previous studies (Pain Physician. 2010;13:321-35).

Conclusion: Routinely collected, objective neurophysiology measurements may help to characterize chronic pain patients, enabling clinicians to evaluate and monitor the integrity of the nervous system, effects of SCS intervention on the spinal cord, effects of medications, and changes in neural activation and conduction properties over time. CV, chronaxie, and rheobase measurements provide information about the type and excitability of neural fibers stimulated, and further analysis of these data may help improve neural selectivity in programming.

Acknowledgements: Study supported by Saluda Medical.

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Figure 1: Distributions of conduction velocity, chronaxie, and rheobase measurements

DisclosuresSMF reports serving as a consultant for Abbott, Medtronic, Nevro, Saluda, SPR, and Vertiflex; and conducting research for Abbott, Medtronic, Nuvectra, and Saluda.AK reports being an employee of Saluda Medical Pty. Ltd.

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Posterior Sacroiliac FusionIntroduction: Pain patients often present with a primary complaint of low back pain (LBP). On exam many of these patients are found to not have LBP but are found to have pain consistent with sacroiliac joint pain i.e. point specific pain @ the mid aspect of the SI joint without a radicular component. Occasionally patients will have tenderness at the superior aspect of the SI joint over the S1 foramen that is also associated with a S1 radiculopathy (buttock/posterior thigh pain). Treatment of SI joint pain has included physical therapy, chiropractic manipulation, injections, prolo therapy, radio frequency lesioning (peripheral nerve stim), and Lateral Fusion with hardware. The latter procedure is only performed by Ortho or Neuro surgeons because of the invasiveness of the procedure. A minimally invasive technique (PainTEQ) can be used by Interventional Pain Management physicians. We report our results following a minimally invasive single joint SI Fusion of 20 patients over the last 6 months.

Objectives: To show efficacy of patient outcomes using a medial, posterior sacroiliac fusion approach.

Materials and Methods: All patients that underwent this modality of treatment had a physical examination, indicating a point specific, reproducible pain. The patients often had an antalgic gait noted.

The patients were then treated with a diagnostic/therapeutic injection using 5ml of 1% lidocaine and 80mg of depo Medrol. The patients were observed 15 minutes post procedure and their pain was then reevaluated. All patients had 100% pain relief 15 min after the procedure. All patients were then reevaluated 1-week post procedure. 20% of patients continued to be pain free 1 week after the procedure, the remaining patients were offered a medial/posterior sacroiliac fusion.

Results: There has been 20 cases that have been completed since October 2018 to present. Of the 20 cases, 55% of the patients (11/20) received 100% pain relief with the average percentage of pain being 72%.

Conclusion: Although there have been different options in treating patients for sacroiliac pain, the medial/posterior sacroiliac fusion has shown significant pain relief in patients. Patients who are examined and properly diagnosed with sacroiliac pain have the option choose a minimally invasive, outpatient, surgical procedure that can result in compelling pain relief.

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Outcomes Using an SCS Device Capable of Delivering Combination Therapy and Advanced Waveforms/Field Shapes

Introduction: Developing “all-in-one” spinal cord stimulation (SCS) systems with capability for multiple types of neurostimulation paradigms likely will empower patients to identify the best treatment approach suitable for their needs. Here, we provide real-world outcomes in patients who used an SCS system designed to combine multiple waveform availability, both sequentially and simultaneously, with an algorithm designed to enable highly manipulatable control of field shape.

Objectives: We present patient outcomes using a new SCS System designed to offer patients the capability to personalize SCS by offering combination therapy (simultaneous or sequential) and waveform automation.

Materials and Methods: This is a consecutive, multi-center case-series based on retrospective chart review as part of an ongoing real-world evaluation of SCS outcomes for chronic pain (Clinicaltrials.gov identifier: NCT01550575). Patients were implanted with an SCS system (Precision Spectra WaveWriter, Boston Scientific) capable of combination therapy (sequential or simultaneous), multiple waveforms and advanced field shapes for low back and/or leg pain. Data collection included: 1) Baseline characteristics: demographics, pain diagnosis 2) procedural information: lead configuration, programming parameters; and 3) pre- and post- implant numerical rating scale pain intensities (0-10 NRS).

Results:To date, 420 patients have been analyzed. A statistically significant improvement in overall pain scores at last follow-up was reported (Baseline NRS: 7.2; mean last follow-up [137±145 days] NRS: 2.2; p<0.0001). A 5.2±2.2 point improvement (NRS score) in overall pain was reported at 3 months and sustained up to 12 months (p<0.0001). Twenty-three percent of patients indicated being free of pain at last follow-up.

Conclusion:These results provide support for the postulate that an SCS system designed to provide combination therapy, multiple waveform options, and enhanced anatomical targeting capabilities, allows for highly effective pain relief outcomes in a patient-specific manner within the real world clinical setting.

WHISPER RCT: AN UPDATED POST-HOC EVALUATION OF SUB-PERCEPTION SCS AT ≤1.2 KHZ IN PREVIOUSLY-IMPLANTED SUBJECTS

Introduction: Results from a recent randomized controlled trial (RCT) demonstrated that equivalent pain relief was achieved using a range of frequencies from 1 to 10 kHz spinal cord stimulation (SCS) with appropriate neural dosing (Thomson SJ. et al. Neuromodulation. 2018).

Objectives: The WHISPER RCT evaluated the safety and clinical effectiveness of sub-perception SCS at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain.Materials and Methods: WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific (ClinicalTrials.gov: NCT02314000). Subjects previously implanted with SCS and a baseline overall pain score ≥6 (with SCS off) at study start were enrolled. Eligible subjects were randomized to either receive sub-perception or supra-perception for a period of 90 days and then crossed over to receive vice versa. At the completion of crossover, outcomes related to overall pain, satisfaction and preference were collected.

Results:The primary endpoint, based on overall pain responder rate (≥ 50% improvement from Baseline) with no increase in medications, was achieved in a pre-specified cohort of 70 randomized subjects (interim analysis) who were previously implanted ~4 years with mean disability score (Oswestry Disability Index) of 69.4. For those subjects using sub-perception SCS, significant pain relief was sustained (p < 0.001) at 1 year. Post-hoc analysis demonstrated that multiple options provide superior outcomes when subjects could choose the most effective option.

Conclusion:The WHISPER study demonstrates that sub-perception SCS at ≤1.2 kHz is safe and effective. Waveform options provided superior outcomes when subjects could choose the most effective therapy.

References:1. Thomson SJ. et al. Neuromodulation. 2018 Jan;21(1):67-76.

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Exploration of High and Low Frequency Options for Sub-Perception Pain Relief: The HALO Study

Introduction: Effective sub-perception Spinal Cord Stimulation (sub-p SCS) can be delivered at 10 kHz1. Moreover, a Level I RCT demonstrated that effective and equivalent analgesia can be achieved at lower kHz frequencies (1-10 kHz) at the appropriate neural dose, thereby enabling significant energy savings.2

Objectives: We sought to determine if a clinical difference (including charge burden) exists when using sub-p SCS at frequencies from 1 kHz down to 10 Hz. Additionally, we endeavored to assess if “sweet spot” identification and targeting is improved in sub-perception SCS using a novel field shape designed to preferentially engage neural elements within the dorsal horn.

Materials and Methods: This is a consecutive, multi-center case-series of patients implanted with an SCS system (Precision Spectra or Precision Spectra WaveWriter, Boston Scientific) for chronic pain. Patients underwent a “sweet spot” search using broad fields at 1 kHz and a novel Dorsal Horn targeting field shape algorithm. Frequency of sub-p stimulation was titrated, and pulse-width and amplitude adjusted. Charge-per-second was also determined.

Results:Baseline NRS score in 30 patients evaluated to date was 8.2. All frequencies assessed (10, 50, 100, 200, 400, 600, 1000 Hz) provided similarly equivalent low back pain relief [NRS range: 2.5-3.1]. Similar results were obtained when assessing for leg and overall pain. Charge-per-second significantly decreased following frequency reduction and dose titration, from 346.9 to 8.9 µC/s, at 1,000Hz and 10Hz, respectively.

Conclusion:Results of this on-going observational case series to date demonstrate that if appropriately dosed at frequencies from 10-1000 Hz, effective pain relief equal to currently available methods of sub-perception SCS can be achieved. Furthermore, charge-per-second can be drastically reduced if the proposed “Rule of Neural Dosing” is applied. Also, broad field application does appear to efficiently determine the optimal neural target (“sweet-spot”) for sub-perception SCS.

References:1. Kapural L., et al. Anesthesiology. 2015 Oct;123(4):851-60.2. Thomson SJ., et al. Neuromodulation. 2018 ;21(1):67-76.

Outcomes Following Utilization of a Device Adaptor in Previously-Implanted Patients Using SCS For Chronic Pain

Introduction: Patients using SCS systems who have endured problems with device longevity and/or loss of efficacy may be able to achieve better outcomes utilizing newer technologies that offer an increased variety of waveforms and programming options to address their chronic pain.

Objectives: In this retrospective study, we examined the outcomes of previously-implanted patients who went on to use a commercially-available adaptor enabling connection to an SCS system that offers multiple neurostimulation based treatment approaches to regain and maintain efficacious therapy.

Materials and Methods: This is a real-world, retrospective study of patients who were previously implanted with an SCS system (commercially-available SCS device, Abbott) who then went on to utilize an adaptor (Precision S8, Boston Scientific) to connect to a new SCS system capable of multiple modality stimulation and/or combination therapy. Pain relief and other associated outcomes with both

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previously-implanted SCS systems and newly connected commercially¬ available systems (Boston Scientific) are being collected.

Results:Data from a total of 8 patients who provided all pain scores have been collected and analyzed to date. Six of 8 patients utilizing a device adaptor reported better pain relief after connection to and use of a multiple waveform SCS system (i.e. pain scores after using current versus previous system at post-baseline follow-up assessment). A mean 4.7 ± 1.9 point improvement was reported using the current system versus a 2.3 ± 2.8 point improvement using the previous system. Conclusion:In this small, multi-center case-series, no patients reported better pain relief using the previous system versus their current system (multiple waveform SCS) when using a device adaptor. The results of this preliminary study suggest that offering previously implanted SCS patients a system capable of providing multiple waveforms can improve pain relief.

A Prospective Global Registry of Real-World Outcomes Using Spinal Cord Stimulation Systems for Chronic Pain

Introduction: Large patient outcome registries are a key part of the compendium of information typically mined to generate real world data and evidence. Real world evidence (RWE) derived from such registries via application of advanced data analytics therefore represents a potentially important aspect of the on-going rational assessment and future development of commercially-available Spinal Cord Stimulation (SCS) devices.

Objectives: We present here a prospective global registry designed to evaluate long-term, clinical application of neurostimulation therapy for pain.

Materials and Methods: This is a prospective, multicenter global registry (RELIEF Registry, Boston Scientific) that aims to assess several various aspects of the pain treatment experience and the safety profile associated with using SCS in up to 1700 participants at up to 81 centers (ClinicalTrials.gov Identifier: NCT01719055). Eligible study participants are trialed for “on label” use only with a commercially-approved SCS system (Boston Scientific) and must sign an IRB-approved informed consent form. All permanently-implanted subjects are followed out to 36-months.

Results:A total of 1,151 subjects at 81 global study sites have been assessed out to 3 years post-implantation. Patient satisfaction (PGIC) assessment determined that 88% of registry participants reported overall therapeutic improvement within the span of this 3-year duration. In addition, a low incidence of explants due to device-related complications of 7.9% was determined with only 2.4% indicating that this was due to inadequate pain relief (% explant per year: 3.6%).

Conclusion:Real-world evidence as derived from large patient registries is needed to assess patient quality of life and device longevity when using SCS to treat chronic pain. The 3-year results of this prospective, multicenter real-world registry demonstrate a low percent explant rate per year and a high percentage of patients reporting therapeutic improvement when using an SCS device to treat their chronic pain.

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