Actively Recruiting
Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-07-28
60
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
X
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old and above, male or female
- Diagnosed with postherpetic neuralgia suitable for peripheral nerve stimulation therapy
- Assessed peripheral sensory system damage through Douleur Neuropathy questionnaire before surgery
- Received conventional treatment with poor effect or intolerable side effects
- Visual analogue scale for pain within 24 hours before surgery is 5 or higher
- Able to understand study purpose, comply with treatment, and willing to sign informed consent form
You will not qualify if you...
- Need for both radio frequency modulation and intrathecal drug infusion treatment simultaneously
- Known cardiac implants such as pacemakers or defibrillators or other implantable neural stimulators
- Severe psychological or mental disorders or non-therapeutic drug dependence
- Expected MRI examination within 30 days after peripheral nerve stimulation implantation
- Expected hospital discharge within 48 hours or less
- Target nerve damage or muscle defects in known pain areas
- Known allergy to skin contact materials (tape or adhesive)
- Allergy to anesthetics such as lidocaine
- Severe heart, liver, kidney, respiratory, or coagulation disorders
- Pregnant or breastfeeding women, or women planning pregnancy within the next 3 months
- Participation in other clinical trials currently or planned after enrollment
- Other conditions deemed unsuitable by the researcher
AI-Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
D
Dong Yang, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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