Peripheral nerve stimulation for the treatment of chronic pain.
R J Mobbs, S Nair, P Blum
https://pubmed.ncbi.nlm.nih.gov/17258129Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06290661
Prospective, Multicentre, Randomised Withdrawal Trial Evaluating Safety and Efficacy of Percutaneous Peripheral Nerve Stimulation for 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
52 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
This research aims to evaluate the safety and effectiveness of percutaneous peripheral nerve stimulation in adults experiencing peripheral neuropathic pain, including conditions such as postherpetic neuralgia and trigeminal neuralgia. The study seeks to answer whether this nerve stimulation method can reduce pain and whether it is safe for patients. It is conducted as a randomized withdrawal trial involving multiple clinical sites. Participants will undergo implantation of a peripheral nerve stimulation electrode device produced by Jiangsu CED Medtech Co., Ltd. After implantation, their pain levels are monitored, and those with at least a 30% reduction in pain scores are randomly assigned to receive either active stimulation or placebo stimulation during a randomized withdrawal period. The study includes an enrollment and baseline period, a treatment period consisting of test, randomized withdrawal, and observation subperiods, and a follow-up period. The device remains implanted for 28 days, after which it is removed. Throughout the study, participants will keep a pain diary recording daily pain scores using the Visual Analogue Scale (VAS), report analgesic medication use, number of awakenings, and any adverse events. Researchers will perform assessments including physical exams, vital signs, laboratory tests, and questionnaires on neuropathic pain and quality of life. Pain scores and other measures are recorded daily during various study phases and at follow-up visits to assess the intervention's impact and safety.
CONDITIONS
Brief Title
Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.
Who Can Participate
Age: 18Years +
All Genders
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 for peripheral sensory system damage using Douleur Neuropathy questionnaire before surgery
- Have received conventional treatment with poor efficacy or intolerance to side effects
- Visual analogue scale (VAS) pain score of 5 or higher within 24 hours before surgery
- Able to understand study purpose, comply with treatment, and willing to sign informed consent
You will not qualify if you...
- Need to receive both radio frequency modulation and intrathecal drug infusion simultaneously
- Have cardiac implants (pacemakers, defibrillators) or other implantable neural stimulators
- Severe psychological or mental disorders or non-therapeutic drug dependence
- Expected to undergo MRI within 30 days after implantation
- Expected hospital discharge within 48 hours or less
- Target nerve damage or muscle defects in pain areas
- Known allergies to skin contact materials or anesthetics such as lidocaine
- Severe heart, liver, kidney, respiratory disease, or coagulation dysfunction
- Pregnant, lactating, or planning pregnancy within three months
- Participation in other clinical trials or plans to join another trial after enrollment
- Any other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Enrollment and Baseline
Duration - At least 4 days
Participants who meet eligibility criteria are enrolled and undergo baseline assessments including vital signs, physical exams, laboratory tests, and pain evaluations before device implantation.
Multiple visits over 4 days
Treatment - Implantation and Test Period
Duration - 7 (±3) days
Participants receive implantation of the peripheral nerve stimulation device followed by a test period where stimulation parameters are adjusted and pain scores are recorded daily.
Daily visits or assessments for 7 days
Treatment - Randomized Withdrawal Period
Duration - 7 days
Participants are randomized to receive either active or placebo stimulation. Pain scores are recorded daily during this 7-day period.
Daily visits or assessments for 7 days
Treatment - Observation Period
Duration - Up to 14 days after randomized withdrawal
Participants continue with stimulation until day 28 after implantation. Device leads are removed on day 28 or earlier if withdrawn.
Visits or assessments until day 28 post-implantation
Follow-up
Duration - At least 14 days after device removal
After device removal or day 28 post-implantation, participants are followed to assess pain and safety outcomes.
Follow-up visits including day 14 after electrode removal
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
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Research Team
D
Dong Yang, PHD
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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