Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.

NCT06290661 · tracked via the Priya Life Science China tracker

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Phase

Not applicable

Started

2023-02-09

Last updated

2025-07-28

Condition(s) studied

Postherpetic NeuralgiaPeripheral Neuropathic PainTrigeminal Neuralgia

Investigational drug(s) / intervention(s)

Active electrostimulationPlacebo electrostimulation

Active electrostimulation: Maintain the electrical stimulation state, and according to the patient's feeling to set the appropriate stimulation parameter range (pain relief and no obvious numbness and discomfort), the programme will be written into the patient's self-control remote control, by the patient according to their own pain situation for the independent control of the stimulation current.

Placebo electrostimulation: No actual electrostimulation

Study summary

The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain. The main questions it aims to answer are:

1. The efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain
2. The safety of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.

Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with peripheral neuropathic pain.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria: * 18 years old and above, male or female * Diagnosed by trained clinical doctors as postherpetic neuralgia, which is an indication for peripheral nerve stimulation therapy; * Assess the damage or disease of the peripheral sensory system through the four questions of Douleur Neuropathy before surgery; * The subject has received conventional treatment but the efficacy is poor, or cannot tolerate the side effects of conventional treatment; * Visual analogue scale for pain within 24 hours before surgery ≥ 5; * The subjects are able to understand the purpose of this study, have sufficient compliance with the research treatment, and are willing to sign an informed consent form; Exclusion criteria: * Subjects who need to receive both radio frequency modulation and intrathecal drug infusion treatment simultaneously; * Subjects who are known to have cardiac implants (pacemakers or defibrillators) or other implantable neural stimulators (spinal cord stimulators or deep brain stimulators, etc.); * Subjects with severe psychological and/or mental disorders and/or non therapeutic drug dependence; * Subjects expected to undergo MRI examination within 30 days after PNS implantation; * Expected to be discharged within 48 hours or less; * Target nerve damage or muscle defects in known pain areas; * Subjects who are known to be allergic to skin contact materials (tape or adhesive); * Allergy to anesthetics such as lidocaine; * Concomitant severe heart disease, liver disease, kidney disease, respiratory system disease, and coagulation dysfunction; * Pregnant women, lactating women, or women planning to have children within the next three months; * Subjects who have participated in any other clinical trial, or who may participate in any other trial after enrollment; * Other situations that the researcher deems unsuitable for participation in this clinical trial

Primary outcome measure(s)

Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period — every day from 7 to 14 days after electrode implantation (randomized withdrawal period)
Researchers will collect visual analogue scale scores of 7 days after the implantation of peripheral nerve stimulation electrode to calculate mean scores of 4 days before randomized withdrawal and evaluate the difference in pain improvement of peripheral nerve stimulation between the two groups (trial and control group) by analyzing the mean change in VAS scores during randomized withdrawal period.
Visual simulation assessment scale collects pain scores after peripheral electrode placement — Every day from 7 to 28 days after electrode implantation, as well as the 14th day after electrode removal
Researchers collected daily pain scores from the day of peripheral nerve stimulation electrode implantation until removal using the VAS pain scale, as well as pain scores on the 14th day after electrode removal.

Trial sites (1)

Facility	City	Region	Status
Union Hospital, Tongji medical college, Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06290661 on ClinicalTrials.gov ↗ ← All trials in China