Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.
NCT ID: NCT06290661
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2023-02-09
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study on the Efficacy of Non-invasive Spinal Cord Electrical Stimulation in Neuropathic Pain
NCT07046143
Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain
NCT03315598
Acute Effects of Transcutaneous Electrical Nerve Stimulation at Acupoints on Nociceptive Transmission: A Mechanism Study Using Pain-Related Evoked Potentials
NCT07267052
Electroacupuncture for PHN: Efficacy and Biomarker Evaluation in a Multicenter, Randomized, Sham-Controlled Trial Protocol
NCT06990854
The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia
NCT04560361
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Enrollment/baseline period This study will be conducted at four clinical trial sites in China with 3 to 6 subjects included in the pretest and the formal trial planned to enroll 56 subjects. All subjects enter screening process after signing the informed consent form (ICF) approved by the ethics committee. Subjects are enrolled who meet inclusion criteria and do not meet any exclusion criteria. Enrolled subjects will undergo vital signs, physical examination, laboratory tests, and visual analogue scale (VAS) scores for pain for at least 4 days, Neuropathic Pain Scale (DN4), and the Short Form Health Survey (SF-36) as part of the screening period assessment prior to electrode implantation.
2. Treatment period 2.1 Implantation of devices Enrolled subjects are implanted with the percutaneous peripheral nerve stimulation system, which was parameterized by the investigator via a programmable controller. Subjects are provided with a "Transcutaneous Peripheral Nerve Stimulation Remote Control Instruction Manual" to guide them in the proper operation and use of the system.
2.2 Test period Investigators will adjust stimulation parameters and record VAS score under different parameters conditions. The enrolled subjects are provided 1 to 5 stimulation therapy patterns parameterized by investigators after the test.
Then the subjects receive continuous stimulation with parameterized patterns of 7 (±3) days and VAS scores are be recorded every day of 7 days. Subjects will enter next stage if their VAS scores decrease more than 30% from baseline level or withdraw the trial as reduction less than 30% and devices are removed.
2.3 Randomized withdrawal period Subject will be classified into random group. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. Both of two groups are performed stimulation in the next 7 days. The subjects of control group will get active stimulation again as the VAS scores back to and maintain 2 days at baseline level. VAS scores will be recorded every day during this period.
2.4 Observation period The devices are on work until 28th day after the implantation in trial group; stimulators are turned on after randomized withdrawal period until 28th day after the implantation in control group.
All subjects have electrode leads removed on day 28 of implantation or at early withdrawal.
3. Follow-up period Investigators will begin follow up as the removal of electrode leads or on the day 28 of implantation. Indicators including VAS score will be evaluated and recorded to assess the efficacy and safety of percutaneous peripheral nerve stimulation during follow-up.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants receiving active electrostimulation after implantation procedure
Twenty-eight participants (anticipated) from different 4 hospital in China whose mean VAS scores decreased more than 30% compared with baseline scores after electrode implantation. They will still receive electrostimulation therapy during randomized withdrawal period.
Active 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.
Participants receiving placebo electrostimulation after implantation procedure
Twenty-eight participants (anticipated) from different 4 hospital in China whose mean VAS scores decreased more than 30% compared with baseline scores after electrode implantation. The electrostimulation of them will be turned off during randomized withdrawal period.
Placebo electrostimulation
No actual electrostimulation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active 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.
Placebo electrostimulation
No actual electrostimulation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
The Second People's Hospital of GuangDong Province
OTHER
Xiamen Hospital of Traditional Chinese Medicine
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Union Hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Mobbs RJ, Nair S, Blum P. Peripheral nerve stimulation for the treatment of chronic pain. J Clin Neurosci. 2007 Mar;14(3):216-21; discussion 222-3. doi: 10.1016/j.jocn.2005.11.007.
Al-Jehani H, Jacques L. Peripheral nerve stimulation for chronic neurogenic pain. Prog Neurol Surg. 2011;24:27-40. doi: 10.1159/000323017. Epub 2011 Mar 21.
Weiner RL, Reed KL. Peripheral neurostimulation for control of intractable occipital neuralgia. Neuromodulation. 1999 Jul;2(3):217-21. doi: 10.1046/j.1525-1403.1999.00217.x.
Slavin KV. Peripheral nerve stimulation for neuropathic pain. Neurotherapeutics. 2008 Jan;5(1):100-6. doi: 10.1016/j.nurt.2007.11.005.
Gilmore C, Ilfeld B, Rosenow J, Li S, Desai M, Hunter C, Rauck R, Kapural L, Nader A, Mak J, Cohen S, Crosby N, Boggs J. Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UHCT-IEC-SOP-016-03-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.