Robert B. Wilson, II, MD, founder and medical director of Piedmont Interventional Pain Care in Salisbury, North Carolina, recently contributed to two significant studies sponsored by the North American Neuromodulation Society (NANS) and Boston Scientific. These studies are to be presented at the 2024 NANS Annual Conference held January 18 – 24, 2024, in Las Vegas, NV. Jointly provided by the Congress of Neurological Surgeons and the North American Neuromodulation Society, this is the premier meeting in the field of neuromodulation.
The NANS meeting showcases the latest advances in the field through cutting-edge plenary sessions, concurrent sessions, and oral abstract presentations. NANS continues to serve as the premier meeting for advancing the science and practice of neuromodulation. Neuromodulation is the application of targeted electrical, chemical, and biological technologies to the nervous system to improve function and quality of life.
Dr. Wilson has participated in several studies relating to spinal cord stimulation delivery. Each study showed positive results of the interventional pain techniques for chronic back pain.
“I was asked to participate in these studies because of my results volume and the benefits of using them. It is important for the science of pain medicine to evaluate procedures that are performed in order to progress in this field,” Dr. Wilson said. “I feel it necessary to share my results and data from these procedures so that they can show proof of being effective. By doing so, insurance carriers can recognize new procedures as beneficial and implement them into their coverage determinations. But, most importantly, it overall benefits my chronic pain patients and provides them with pain-relieving procedures that allow us to avoid or minimize opioid use.”
Real-World Evaluation of a Multimodal SCS-System Designed to Provide Patient Specific Neurostimulative Therapy for Chronic Pain
Introduction: Due to the varying and subjective nature of the experience of pain and its myriad clinical presentations, providing patients selected for Spinal Cord Stimulation (SCS) with a device that is able to employ a wide range of parameters with multiple programming options is increasingly recognized as an important aspect for enabling efficient and effective treatment for chronic pain.1-3 A recently launched, commercially-available SCS device capable of full-body MRI can provide an array of paresthesia-based and sub-perception-based neurostimulation modalities that allows for engagement with different mechanisms of action, including fast-acting sub-perception therapy (FAST), combination therapy, and other multiple waveforms/field shapes.
Methods: This is an on-going, consecutive, multi-center, real-world, observational case-series evaluation (Clinicaltrials.gov: NCT01550575) that retrospectively assesses patients with chronic pain who used a newly-available SCS System (WaveWriter Alpha, Boston Scientific) designed with full-body MRI compatibility that provides for the delivery of supra- and/or sub-perception neurostimulative programming modalities either alone or combined so as to engage multiple mechanisms. These approaches can be optimized in a patient-specific manner such as including (but not limited to) novel Fast-Acting Sub-Perception Therapy (FAST) and/or a new, customizable, sub-perception-based field shape algorithm enabling precise conformational shaping and targeting of electric fields (Contour, Boston Scientific). At baseline and at follow-up visits, pain relief outcomes are collected as well as other clinical endpoints, when available per standard of care.
Results: To date, data from a total of 201 patients (mean age 66.7-years, pre-trial = pain score 7.7 ± 1.7) have been reported so far with a mean follow-up duration time of 271 days. At last follow-up, a mean 4.9-NRS point improvement was noted (p<0>
Conclusion: On-going data collection and evaluation from this multicenter, realworld, observational, case-series demonstrate significant improvement of chronic pain in patients with a new SCS system capable of full-body MRI and the delivery of multiple paresthesia-based and sub-perception-based modalities. This data continues to show that providing patients with SCS systems that are equipped with capabilities allowing for patient-specific delivery of therapeutic neurostimulation can facilitate clinically-meaningful and long-term, effective outcomes.
References:
- Fishman MA, Antony A, Esposito M, Deer T, Levy R. The Evolution of Neuromodulation in the Treatment of Chronic Pain: Forward-Looking Perspectives. Pain Med. 2019 Jun 1;20(Suppl 1):S58-S68.
- Sheldon B, Staudt MD, Williams L, Harland TA, Pilitsis JG. Spinal cord stimulation programming: a crash course. Neurosurg Rev. 2021 Apr;44(2):709-720.
- Kallewaard JW, Paz-Solis JF, De Negri P, et al. Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience. J Clin Med. 2021 Sep 10; 10(18):4085.
Pain Relief Using Interspinous Decompression for Treatment of Lumbar Spinal Stenosis Among Severe Pain Patients
Introduction: Indirect Decompression Systems (IDS) or Interspinous Spacers are an option in well-selected patients with impaired physical function who experience relief in flexion from symptoms of leg, buttock and/or groin pain due to lumbar spinal stenosis (LSS). A growing body of published clinical evidence has demonstrated excellent long-term clinical benefit with sustained pain relief, improved quality of life and medication reduction up to 5-years post-implant.1-3 Real-world reports demonstrated excellent long-term clinical benefit for patients including leg pain responder rate and pain severity of 75% and 60% respectively at 12-months post-operation.4
Methods: This is a consecutive, multi-center case-series based on retrospective chart review as part of an on-going real-world evaluation of IDS outcomes for lumbar spinal stenosis (Clinicaltrials.gov identifier: NCT01550575). Patients were implanted with an indirect decompression system (Superion, Boston Scientific). Assessments collected include (but not limited to) baseline characteristics such as demographics, medical history, pain diagnosis, procedural information such as implant level, pre and post-implant pain (NRS) and quality-of-life scores.
Results: To date, data from 175 patients [age: 73.3 ± 11.1 (Mean ± STD), 103 females] with severe pain were implanted with IDS for LSS symptoms at 11 centers. Patients reported a mean NRS pain score 8.6 ± 0.8 prior to IDS implant. A mean 3.8 ± 3.0-point improvement (p<0>
Conclusion: Results from this ongoing, real-world, observational case-series of severe pain patients (8 or more on NRS), demonstrated a substantial improvement in pain relief with the use of Indirect Decompression Systems (IDS) for treatment of LSS. This preliminary evidence aligns with reports in the peer-reviewed literature.
References:
- Nunley et al., Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis. Clin Interv Aging 2017 Sep 6;12:1409-1417.
- Nunley PD, Patel VV, Omdorff DG, Lavelle WF, Block JE, Geisler FH. Interspinous process decompression improves quality of life in patients with lumbar spinal stenosis. Minim Invasive Surg. 2018 Jul 2;2018:1035954.
- Nunley PD, Deer TR, Benyamin RM, Staats PS, Block JE. Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis. J Pain Res. 2018;11:2943-2948.
- Tekymster G., et al. Interspinous Process Decompression with the Superion® Spacer for Lumbar Spinal Stenosis: Real-World Experience from a Device Registry. Med Devices (Auckl). 2019 3; 12:423-427.
Dr. Wilson has grown a pain care practice based on interventional treatment options for pain. Piedmont Interventional Pain Care is dedicated to reducing or eliminating the need for pain medications and providing effective procedures that help patients lead more active and fulfilling lifestyles.
Dr. Wilson is an active advocate for preventing opioid abuse and serves on the opioid task forces for the Department of Health and Human Services, the Industrial Commission of North Carolina, the North Carolina Medical Board, and the North Carolina Medical Society. Additionally, Dr. Wilson is a long-standing member of the Pain Society of the Carolinas, also known as PSOC, and past president of the PSOC. He also has served as chairman of the government advocacy committee. Dr. Wilson is a lecturer for Boston Scientific and is committed to research and education regarding interventional pain management.
For more information about Dr. Wilson and Piedmont Interventional Pain Care, please visit www.piedmontpaincare.com.
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About NANS: The North American Neuromodulation Society (NANS) is dedicated to being the premier organization representing neuromodulation. NANS promotes multidisciplinary collaboration among clinicians, scientists, engineers, and others to advance neuromodulation through education, research, innovation, and advocacy. Through these efforts, NANS seeks to promote and advance the highest quality of patient care.
Neuromodulation is the application of targeted electrical, chemical, and biological technologies to the nervous system to improve function and quality of life.
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