WIPM POSITION STATEMENT

Implantable Peripheral Nerve Stimulation (PNS)

The Society of Women Innovators in Pain Management (WIPM) represents women who participate in research, advocacy and delivery of pain management care. As an element of advocacy, the Society is attentive to supporting therapies that are proven beneficial in treatment of patients suffering with chronic pain. As such, WIPM firmly advocates for the utilization of temporary and permanent Peripheral Nerve Stimulation (PNS) devices as standard of care in the comprehensive management of patients suffering from moderate to severe chronic pain who have continued to experience moderate to severe chronic pain following two or more conventional treatments.

Recognizing the limitations of existing treatments and the imperative to alleviate patient suffering, WIPM underscores the following key points:

  • Access and Eligibility: WIPM emphasizes the importance of facilitating access to PNS devices for patients who can derive significant benefit from them. Patients who have endured persistent pain despite more conservative interventions such as physical therapy, injections, ablation and oral analgesics should have the opportunity to explore PNS as a viable alternative. PNS devices that have achieved FDA clearance and demonstration of positive outcomes published in peer-reviewed journals, especially those with randomized controlled trials and a significant body of real-world evidence should be readily accessible to eligible patients.

  • Safety and Efficacy: The safety profile of PNS devices is well-established, with longitudinal data supporting its efficacy and durability. WIPM acknowledges the substantial body of clinical evidence validating the effectiveness of PNS across various pain syndromes, including neuropathic and non-neuropathic conditions.

  • Contrary to its unfortunate characterization by some payers, PNS is not an experimental or investigational treatment; rather, it represents a clinically validated approach endorsed by numerous peer-reviewed publications.  The following PNS systems have achieved FDA clearance:

    • StimRouter System – Bioventis

    • SPRINT PNS System – SPR Therapeutics

    • Freedom PNS System – Curonix

    • Nalu PNS System – Nalu Medical

In light of the compelling clinical evidence and regulatory clearance, WIPM recommends the judicious utilization of PNS by qualified healthcare professionals.  Policymakers and payers are urged to facilitate timely access to FDA-cleared PNS technologies, ensuring that patients receive optimal care based on clinical need and evidence-based practice.

Finally, given the above:

WIPM considers temporary implantation of PNS leads medically necessary for patients with chronic, intractable pain when all of the following criteria are met:

  1. The PNS treatment is provided in accordance with FDA guidelines and indications; and,

  2. Patient has chronic pain (present for >6 months), refractory to, at minimum, two conservative methods of treatment including but not limited to:

a. Oral NSAIDs/Analgesics/Gabapentinoids > 3 weeks unless contra-indicated;
b. Activity modification > 6 weeks;
c. Physical therapy (minimum of 4 visits within a 3-month period);
d. Injection therapy (e.g. steroid injection, nerve block, radiofrequency ablation)

WIPM further considers permanent implantation of PNS systems medically necessary for patients with chronic, intractable pain when all of the following criteria are met:

  1. The PNS treatment is provided in accordance with FDA guidelines and indications;

  2. Patient has chronic pain (present for >6 months), refractory to, at minimum, two conservative methods of treatment including but not limited to:

a. Oral NSAIDs/Analgesics/Gabapentinoids > 3 weeks unless contra-indicated;
b. Activity modification > 6 weeks;
c. Physical therapy (minimum of 4 visits within a 3-month period);
d. Injection therapy (e.g. steroid injection, nerve block, radiofrequency ablation)

3. Patient has achieved at least 50% pain relief with temporary PNS

4. Pain relief was not sustained following withdrawal of the temporary lead, or when moderate to severe pain has returned post lead withdrawal.

Key References:

  • Randomized Controlled Trials (RCTs)

    • Chae, J., David, T.Y., Walker, M.E., Kirsteins, A., Elovic, E.P., Flanagan, S.R., & Fang, Z.P. (2005) Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. American journal of physical medicine & rehabilitation, 84(11), 832-842.

    • Wilson, R.D., Gunzler, D.D., Bennett, M.E., & Chae, J. (2014). Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial. American journal of physical medicine & rehabilitation/Association of Academic Physiatrists, 93(1), 17.

    • Deer, T., Pope, J., Benyamin, R., Vallejo, R., Friedman, A., Caraway, D., ... & Mekhail, N. (2016). Prospective, multicenter, randomized, double‐blinded, partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve origin. Neuromodulation: Technology at the Neural Interface, 19(1), 91-100.

    • Gilmore CA, Ilfeld BM, Rosenow JM, Li S, Desai MJ, Hunter CW, Rauck RL, Nader A, Mak J, Cohen SP, Crosby ND, Boggs JW. (2020). Percutaneous 60-day Peripheral Nerve Stimulation Implant Provides Sustained Relief of Chronic Pain Following Amputation: 12-month Follow-Up of a Randomized, Double-Blind, Placebo-Controlled Trial. Regional Anesthesia and Pain Medicine, 2020; 45:44-5.

  • Literature./Systematic Reviews:

    • Deer TR, et. al. “A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain”. Pain Medicine. (2020). August; 21(8): 1590- 1603.

    • Xu, J., Sun, Z., Wu, J., Rana, M., Garza, J., Zhu, A. C., ... & Cheng, J. (2021). Peripheral nerve stimulation in pain management: a systematic review. Pain Physician, 24(2), E131.

    • Helm S. et. al. “Peripheral Nerve Stimulation for Chronic Pain: A Systematic Review of Effectiveness and Safety”. Pain and Therapy. 2021. Dec;10(2): 985-1002.

    • Strand N. et. al. “Evidence -Based Guidelines from the American Society of Pain and Neuroscience for the Use of Implantable Nerve Stimulation in the Treatment of Chronic Pain”. Journal of Pain Research. 2022. August 23; 15: 2483-2504.

  • Other Significant PNS Publications:

    • Naidu R, Li S, Desai MJ, Sheth S, Crosby ND, Boggs JW. (2022) 60-Day PNS Treatment May Improve Identification of Delayed Responders and Delayed Non-Responders to Neurostimulation for Pain Relief, Journal of Pain Research, March 2022.

    • Gilligan, et. al. (2023) “Long Term Outcomes of Restorative Neurostimulation in Patients with Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two Year Results of the ReActiv8-B Pivotal Trial”. Neuromodulation. 2023. January; 26(1): 87-97.

    • Gilmore CA, Deer TR, Desai MJ, Hopkins TJ, Li S, DePalma MJ, Cohen SP, McGee MJ, Boggs JW. (2023). Durable patient-reported outcomes following 60-day percutaneous peripheral nerve stimulation (PNS) of the medial branch nerves, Interventional Pain Medicine, March 2023.

    • Huntoon MA, Slavin KV, Hagedorn JM, Crosby ND, Boggs JW. (2023). A Retrospective Review of Real-world Outcomes Following 60-day Peripheral Nerve Stimulation for the Treatment of Chronic Pain, Pain Physician, May 2023.

    • Dickerson DM, Kalia H, Vorenkamp K, Gunnarsson C, Epstein AJ, Keuffel EL, Stultz M, Crosby ND, Huntoon MA. (2024). Cost Benefits of Medicare Patients Receiving 60-Day PNS Treatment Versus Other Forms of Permanent PNS. (North American Neuromodulation Society Annual Meeting, January 2024). Manuscript submitted for publication.