Status:
RECRUITING
Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
The Second People's Hospital of GuangDong Province
Conditions:
Postherpetic Neuralgia
Peripheral Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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: ...
Detailed Description
The investigators divide study process into 3 main periods called enrollment/baseline period, treatment period and follow-up period. The treatment period is classified into test period, randomized wit...
Eligibility Criteria
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
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06290661
Start Date
February 9 2023
End Date
December 30 2026
Last Update
July 28 2025
Active Locations (1)
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1
Union Hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022