Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Per… (NCT06290661) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.
China60 participantsStarted 2023-02-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dise…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period
Timeframe: every day from 7 to 14 days after electrode implantation (randomized withdrawal period)