EDUCATIONAL GUIDE Interventional Pain Management 2019 - The Florida Society of Interventional Pain Physicians Florida Society of Physical Medicine ...
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The Florida Society of
Interventional Pain Physicians
and the
Florida Society of Physical Medicine
and Rehabilitation
Present
Interventional
Pain Management
2019
EDUCATIONAL GUIDE
July 18 - 21, 2019
The Diplomat Hotel, Hollywood, FL
FSIPP/FSPM&R 2019
st
July 18-21 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 Steven Falowski, MD Nagy Mekhail, MD,PhD
Ramsin Benyamin, MD Roger Fillingim, PhD Quang Nguyen, MD
Maulik Bhalani, MD Orlando Florete, MD Steve Passik, MD
Jennifer Bolen, JD Vincent Galan, MD, MBA, Trevor Persaud, DO
Randall Braddom, MD DAPBM Jason Pope, MD
Lorrie Brown, MD Vidur Ghantiwala, DO Rene Przkor, MD
Jeff Buchalter, MD Christopher Gharibo, MD Rosa Rodriguez, MD
Jorge Caceres, MD Stanley Golovac, MD Elizabeth Shaw, JD
Aaron Calodney, MD Scott Griffith, MD Sanford Silverman, MD
Ken Candido, MD Jeffrey Gudin, MD Douglas Spiel, MD
Harold Cordner, MD Hans Hansen, MD Peter Staats, MD, MBA
Michael Creamer, DO Kazi Hassan, MD Carrie Steichen, DO
Harold Dalton, DO Carl “Fritz” Hayes, MD Cliff Swezey, Ed.D
Miguel De la Garza, MD Matthew Imfeld, MD Deborah Tracy, MD
Oscar DePaz, MD Jon Johnson, MD Andrea Trescot, MD
Sandeep Dhanjal, MD Nick Knezevic, MD, PhD Richard Tucker MD
Sudhir Diwan, MD Sean Li, MD Ricardo Vallejo, MD, PhD
Daniel Duncanson, MD Craig Lichtblau, MD Krystal Yankowski, DO
Richard Epter, MD Jesse Lipnick, MD Jeffrey Zuckerman, MD
Michael Esposito, 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 Goodman
Alabama 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 of
Post-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, so
one-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 lower
extremity 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
6Efficacy of Bilateral Intra-articular CNTX-4975 Injection for
Management of Painful Knee Osteoarthritis
1 1 1 1 2
Randall M. Stevens, MD, Kimberly Guedes, RN, BSN, Nilam Mistry, BS, Paul Tiseo, PhD, B. Duncan X. Lascelles, BVSc, PhD,
1 1 3
James N. Campbell, MD, Mario R. Mendoza, MD, MS, David Ball, MBBS
1 2
Centrexion Therapeutics Corp., Boston, MA, USA; Translational Research in Pain, North Carolina State University, Raleigh, NC;
3
MAC 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 (P1019 5 2 5 2
1020 5 3 4 2
a
0–10 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
1 1 1 1
Randall M. Stevens, MD, Kimberly Guedes, RN, BSN, Nilam Mistry, BS, Paul Tiseo, PhD, B. Duncan X.
2 1 1 3
Lascelles, BVSc, PhD, James N. Campbell, MD, Mario R. Mendoza, MD, MS, David Ball, MBBS
1 2
Centrexion Therapeutics Corp, Boston, MA; Translational Research in Pain Program, North Carolina State
3
University, Raleigh, NC; MAC 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 10‒20
minutes 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
8Last 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-4975
cooling.
a
Lower 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.
9Defining 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
1,2
suboptimal. Current SCS therapies are fixed-output and do not account for large variation in electrical field strength due to
3
changes in distance between the electrode and SC. 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.
10Fig. 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.
11Fig. 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 Investigators
Premier 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.
12Disclosures
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.
Evoked compound action potentials to guide lead placement:
a neuromonitoring technique—case series
Steven M. Falowski, MD1; Milan Obradovic, MBiomedE2
1
Neurosurgical 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.
13Material 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
Figure 1: Distributions of conduction velocity, chronaxie, and rheobase measurements
Disclosures
SMF 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.
15Posterior Sacroiliac Fusion
Introduction: 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.
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).
16Results: 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
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
18previously-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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