Mechanisms of Stimulation for Pain Alleviation

NCT06741579•Stanford University

Summary

This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Our goal is to compare treatment outcomes and trial response rate across the control and interventional device groups.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults aged 18 or older with clinically diagnosed unilateral CNP in the lower back, pelvis, or lower extremities, defined (per IASP classification) as persistent or recurrent neuropathic pain caused by a peripheral nerve lesion, history of a plausible nerve trauma, pain onset in temporal relation to the trauma, and pain distribution within the innervation territory of a peripheral nerve (or nerves).14 Negative and positive sensory symptoms or signs must be compatible with the innervation territory of the affected nerve. Can be post-traumatic, post-surgical, nerve compression, nerve ischemia, peripheral nerve injury, painful scar, nerve entrapment, mononeuropathy with or without loss of motor function
•Patients enrolled in this study must already have been referred for or have an existing order for PNS therapy (either Nalu or SPR SPRINT), prior to consent and enrollment in this study, as part of their routine medical care. Patients cannot receive a referral for PNS device as part of the study procedures.
•Positive response (at least 50% pain relief) to diagnostic nerve block(s) at the suspected site(s) of CNP.
•Chronic (at least 6 months duration), intractable peripheral neuropathic pain; any nociceptive pain must be less prominent than the neuropathic pian.
•Fluent in English writing, reading, and speaking
•Ability and willingness to complete online assessments
•Williness to refrain from physical activity for at least 7 days post-lead placement.
•Willingness to refrain from physical activity or exercise causing muscle and/or joint soreness for 48 hours prior to QST, illicit drugs (marijuana) for 12 hours, as-needed (PRN) pain medications (e.g., NSAIDs, acetaminophen, opioids) for 12 hours prior to QST, and alcohol and nicotine on the day of QST prior to testing\*

Exclusion Criteria

•Conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
•Active cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome
•Painful polyneuropathy (e.g., metabolic, autoimmune, familial, infectious disease, environmental toxins, treatment with neurotoxic drug)
•Chronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)
•Peripheral vascular disease
•Diabetic neuropathy
•Another pain diagnosis affecting the CNP site that could interfere with study procedures, accurate reporting and/or could confound evaluation of study endpoints (e.g., post-herpetic neuralgia)
•Other active implantable devices (e.g., implantable cardioverter defibrillator, spinal cord stimulator, dorsal root ganglion stimulator, sacral nerve stimulator, deep brain stimulator, intrathecal pump)
•Pregnancy, breastfeeding, or planning to conceive
•Systemic infection or local infection at the anticipated PNS implant site
+13 more criteria

Locations (1)

Stanford University

Palo Alto, California, United States

Key Dates

Start Date

September 26, 2025

Primary Completion Date

August 1, 2028

Completion Date

November 1, 2028

Last Updated

October 2, 2025

Enrollment

148

ESTIMATED participants

Conditions

Chronic Neuropathic Pain in the Low Back and LegsPeripheral Nerve StimulationChronic Neuropathic Pain

Interventions

Peripheral Nerve Stimulation

DEVICE

Conventional Care Regimen

PROCEDURE

Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study

NCT06004882

Peripheral Nerve StimulationGenicular Nerves+1 more

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RECRUITINGPHASE2

Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial

NCT07301632

Chronic Neuropathic Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Mechanisms of Stimulation for Pain Alleviation

Inclusion Criteria

Exclusion Criteria

Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study

Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial

Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain

Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain