DESCRIPTION
Percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) have been evaluated for the treatment of a variety of chronic musculoskeletal or neuropathic pain conditions including low back pain, neck pain, diabetic neuropathy, chronic headache, and surface hyperalgesia. The location of stimulation with PENS is determined by proximity to the pain in which needles are inserted either around or immediately adjacent to the nerves serving the painful area. The mechanism of action is unknown, but it is purported that the electrical pulses block the transmission of pain to nerve fibers or may stimulate the release of endorphins or serotonin.
PNT is a variant of PENS in which fine filament electrode arrays are placed near the area causing pain. It is proposed that PNT inhibits pain transmission by creating an electrical field that hyperpolarizes C fibers, thus preventing action along the pain pathway.
Percutaneous electrical nerve field stimulation (PENFS) consists of a disposable battery-operated stimulator that is worn behind the ear and connected to stimulation needles placed along branches of the cranial and occipital nerves. Multiple nerve branches are stimulated remotely rather than a specific nerve at the site of the pain. PENFS has been evaluated for the treatment of a variety of conditions including but not limited to abdominal pain associated with irritable bowel syndrome (i.e., IB-STIM) and reduction of opioid withdrawal symptoms (e.g., NSS-2 BRIDGE, Neuro-Stim).
POLICY
Percutaneous electrical neurostimulation (PENS), percutaneous neuromodulation therapy (PNT), and percutaneous electrical nerve field stimulation (PENFS) are considered investigational for all indications.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
The literature addressing percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) consists primarily of small, controlled trials with unclear blinding and short follow-up. The literature addressing percutaneous electrical nerve field stimulation (PENFS) also consists of small, controlled trials with short follow-up. The available evidence is insufficient to permit conclusions concerning the effect of this procedure on health outcomes.
SOURCES
American Association of Neuromuscular and Electrodiagnostic Medicine. (2011, February). Evidence-based guideline: treatment of painful diabetic neuropathy - report of the American Association of Neuromuscular and Electrodiagnostic Medicine, the American Academy of Neurology, and the American Academy of Physical Medicine & Rehabilitation. Retrieved September 15, 2021 from https://www.aanem.org/.
American Gastroenterological Association. (2022). AGA clinical practice guideline n the pharmacological management of irritable bowel syndrome with diarrhea. Retrieved January 23, 2024 from https://www.gastrojournal.org/article/S0016-5085(22)00391-2/pdf.
American Society of Anesthesiologists Task Force on Chronic Pain Management; American Society of Regional Anesthesia and Pain Medicine. (2010). Practice guidelines for chronic pain management: An updated report by the American Society of Anesthesiologists task force on chronic pain management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology, 112 (4), 810-833.
BlueCross BlueShield Association. Evidence Positioning System. (6:2023). Percutaneous electrical nerve field stimulation for irritable bowel syndrome (7.01.29). Retrieved January 23, 2024 from www.bcbsaoca.com/eps/. (8 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (8:2023). Percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy (2.01.106). Retrieved January 23, 2024 from www.bcbsaoca.com/eps/. (34 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for assessing patient’s suitability for electrical nerve stimulation therapy (160.7.1). Retrieved December 27, 2019 from https://www.cms.gov.
He, D.P., Zhang, J., & Bai, Z.F. (2017). Percutaneous electrical nerve stimulation for chronic knee pain: a randomized, sham-controlled trial. Alternative Therapies in Health and Medicine, 25 (2), 30-34. Abstract retrieved January 24, 2018 from PubMed database.
Kovacic, K., Hainsworth, K., Sood, M., Chelimsky, G., Unteutsch, R., Nugent, et al. (2017). Neurostimulation for abdominal pain-related functional gastrointestinal disorders in adolescents: a randomised, double-blind, sham-controlled trial. The Lancet Gastroenterology & Hepatology, 2 (10), 727–737. (Level 2 evidence)
Li, H., & Xu, Q. (2017). Effect of percutaneous electrical nerve stimulation for the treatment of migraine. Medicine, 96 (39), e8108. (Level 2 evidence)
National Institute for Health and Care Excellence. (2013, March). Percutaneous electrical nerve stimulation for refractory neuropathic pain. Retrieved January 24, 2018 from www.nice.org.uk/guidance.
Rossi, M., DeCarolis, G., Liberatoscioli, G., Iemma, D., Nosella, P., & Nardi, L.F. (2016). A novel mini-invasive approach to the treatment of neuropathic pain: the PENS study. Pain Physician, 19 (1), E121-E128. Abstract retrieved March 30, 2016 from PubMed database.
Santucci, N.R., Sahay, R., El-Chammas, K.I., Graham, K., Wheatley, M., Vandenbrink, M., et al. (2023). Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders. Frontiers in Pain Research, doi: 10.3389/fpain.2023.1251932. (Level 4 evidence)
U.S. Food and Drug Administration. (2002, September). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database K022241. Retrieved January 24, 2018 from http://www.fda.gov.
U.S. Food and Drug Administration. (2002, September). Center for Devices and Radiologic Health. De Novo Classification Request For IB-STIM DEN180057. Retrieved November 22, 2021 from http://www.fda.gov.
U.S. Food and Drug Administration. (2002, September). Center for Devices and Radiologic Health. De Novo Classification Request For NSS-2BRIDGE DEN170018. Retrieved December 3, 2021 from http://www.fda.gov.
U.S. Food and Drug Administration. (2005, December). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database K052289. Retrieved December 12, 2011 from http://www.fda.gov.
U.S. Food and Drug Administration. (2006, August). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database K061166. Retrieved December 12, 2011 from http://www.fda.gov.
Winifred S. Hayes, Inc. Evolving Evidence Review. (2021, March). IB-Stim (Innovative Health Solutions) for treatment of pain associated with irritable bowel syndrome. Retrieved November 22, 2021 from www.Hayesinc.com/subscribers. (5 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Evolving Evidence Review. (2022, July; last update search July 2023). IB-Stim (NeurAxis) for treatment of pain associated with irritable bowel syndrome in adolescents. Retrieved January 23, 2024 from www.Hayesinc.com/subscribers. (11 articles and/or guidelines reviewed)
Woodbury, A., Krishnamurthy, V., Gebre, M., Napadow, V., Bicknese, C., Liu, M., et al. (2021). Feasibility of auricular field stimulation in fibromyalgia: Evaluation by functional magnetic resonance imaging, randomized trial. Pain medicine (Malden, Mass.), 22(3), 715-726. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 3/1980
MOST RECENT REVIEW DATE: 3/14/2024
ID_BT
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