Implantable Peripheral Nerve Stimulation in the Management of Chronic Pain

Publication Date: November 27, 2024
Last Updated: December 18, 2024

Summary of Recommendations

There is evidence supporting the accuracy and value of diagnostic methods for diagnosing conditions amenable to peripheral nerve stimulation. (IV, Moderate)
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The evidence of effectiveness of peripheral nerve stimulation in managing chronic pain, based on evidence synthesis utilizing comprehensive and systematic review of the literature with methodologic quality assessment of all studies, applying GRADE criteria, and best evidence synthesis for implantable peripheral nerve stimulation systems following a trial or selective lumbar medial branch stimulation without a trial, is Level III or fair with moderate certainty utilizing GRADE criteria. (III, Moderate)
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The evidence of effectiveness of peripheral nerve stimulation in managing chronic pain based on evidence synthesis utilizing comprehensive and systematic review of the literature with methodologic quality assessment of all studies, applying GRADE criteria, and best evidence synthesis for implantable stimulation systems following temporary peripheral nerve stimulation for 60 days is Level III or fair with moderate certainty utilizing GRADE criteria. (III, Moderate)
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Based on the evidence and the recommendations, indications may be expanded from present CMS guidance with addition of craniofacial pain, phantom limb pain, and low back pain, either nociceptive or neuropathic, with present evidence showing Level III or fair with moderate certainty utilizing GRADE criteria. (III, Moderate)
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It is important to understand each type of peripheral nerve stimulation implant with features of the equipment and technical requirements. (II, Strong)
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Based on the available evidence and all the available guidance, patient education is a crucial aspect of success of peripheral nerve stimulation. (II, Strong)
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Risk stratification of peripheral nerve stimulation, based on ASIPP guidelines: low risk for peripheral nerve stimulation trial and implantation of extremities and other superficial nerves, moderate risk for lumbar medial branches and high risk for thoracic and cervical medial branches, trigeminal and cranial nerve blocks and nerve stimulation. (II, Moderate)
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Antiplatelet and anticoagulant therapy guidelines in continuation, discontinuation, and re-establishment are utilized as per ASIPP guidelines for low- and high-risk procedures. (II, Moderate)
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Peripheral Nerve Stimulation Systems

  • The following peripheral nerve stimulation systems are commercially available in the United States after having generally received broad FDA clearance for the management of chronic intractable pain.
    • Freedom® Peripheral Nerve Stimulator (PNS) System (Curonix LLC, 2017)
    • StimRouter® Neuromodulation System (Bioness, now Bioventus, 2015)
    • SPRINT® PNS System (SPR® Therapeutics, Inc., 2016)
    • Nalu™ Neurostimulation System (Nalu Medical, Inc., 2019)
    • ReActiv8® Implantable Neurostimulation System (Mainstay Medical Limited, 2020)

Recommendation Grading

Disclaimer

The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.

Overview

Title

Implantable Peripheral Nerve Stimulation in the Management of Chronic Pain

Authoring Organization

American Society of Interventional Pain Physicians

Publication Month/Year

November 27, 2024

Last Updated Month/Year

December 18, 2024

Document Type

Guideline

Country of Publication

US

Document Objectives

Peripheral nerve stimulation (PNS) has been used for over 50 years to treat chronic pain by delivering electrical pulses through small electrodes placed near targeted peripheral nerves those outside the brain and spinal cord. Early PNS systems often required invasive neurosurgical procedures. However, since 2015, the Food and Drug Administration (FDA) approved percutaneously implanted PNS leads and neurostimulators offering a much less invasive, non-opioid option for managing recalcitrant chronic pain. The following FDA-cleared PNS systems are commercially available in the United States for the management of chronic, intractable pain: reedom® Peripheral Nerve Stimulator (PNS) System; SimRouter® Neuromodulation System; SPRINT® PNS System; Nalu™ Neurostimulation System; ReActiv8® Implantable Neurostimulation System. The American Society of Interventional Pain Physicians (ASIPP) has published evidence-based consensus guidelines for the application of PNS systems in managing chronic pain. The guidelines aim to provide evidence-based recommendations for the utilization of peripheral nerve stimulation (PNS) in the management of moderate to severe chronic pain. These guidelines exclude field stimulation, or sacral nerve stimulation. These evidence-based guidelines support the use of implantable peripheral nerve stimulation leads and neurostimulators in patients with moderate to severe chronic pain refractory to two or more conservative treatments. These guidelines aim to optimize patient outcomes and promote health equity through the integration of PNS technology in clinical practice.

Inclusion Criteria

Male, Female, Adult, Older adult

Health Care Settings

Ambulatory, Outpatient, Operating and recovery room

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Treatment, Management

Diseases/Conditions (MeSH)

D059350 - Chronic Pain, D010525 - Peripheral Nerves

Keywords

chronic pain, peripheral neuropathy, interventional techniques, peripheral nerve stimulation, peripheral neuropathic pain, selective lumbar medial branch stimulation

Source Citation

Manchikanti L, Sanapati MR, Soin A, Kaye AD, Kaye AM, Solanki DR, Chen GH, Nampiaparampil D, Knezevic NN, Christo P, Bautista A, Karri J, Shah S, Helm Ii S, Navani A, Wargo BW, Gharibo CG, Rosenblum D, Luthra K, Patel KG, Javed S, Reuland W, Gupta M, Abd-Elsayed A, Limerick G, Pasupuleti R, Schwartz G, Chung M, Slavin KV, Pampati V, Hirsch JA. Comprehensive Evidence-Based Guidelines for Implantable Peripheral Nerve Stimulation (PNS) in the Management of Chronic Pain: From the American Society Of Interventional Pain Physicians (ASIPP). Pain Physician. 2024 Nov;27(S9):S115-S191. PMID: 39565237.