RecruitingNot ApplicableNCT06290661

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

Prospective, Multicentre, Randomised Withdrawal Design of a Clinical Trial Evaluating the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System for Patients With Peripheral Neuropathic Pain.


Sponsor

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

Enrollment

60 participants

Start Date

Feb 9, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Active electrostimulation and a medical device called Placebo electrostimulation for people with peripheral neuropathic pain, postherpetic neuralgia, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive 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.

DEVICEPlacebo electrostimulation

No actual electrostimulation


Locations(1)

Union Hospital, Tongji medical college, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06290661


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