Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.

NCT06290661 | Recruiting DMC

• 1 other identifier: UHCT-IEC-SOP-016-03-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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:

1. 1.The efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain
2. 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.

Conditions

Postherpetic Neuralgia; Peripheral Neuropathic Pain; Trigeminal Neuralgia

Keywords

Peripheral Nerve Stimulation; peripheral neuropathic pain

Outcome Measures

Primary Outcomes (2)

• Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period

  Researchers will collect visual analogue scale scores of 7 days after the implantation of peripheral nerve stimulation electrode to calculate mean scores of 4 days before randomized withdrawal and evaluate the difference in pain improvement of peripheral nerve stimulation between the two groups (trial and control group) by analyzing the mean change in VAS scores during randomized withdrawal period.

  every day from 7 to 14 days after electrode implantation (randomized withdrawal period)

• Visual simulation assessment scale collects pain scores after peripheral electrode placement

  Researchers collected daily pain scores from the day of peripheral nerve stimulation electrode implantation until removal using the VAS pain scale, as well as pain scores on the 14th day after electrode removal.

  Every day from 7 to 28 days after electrode implantation, as well as the 14th day after electrode removal

Secondary Outcomes (7)

• Proportion of subjects whose pain relief more than 30%

  Every day for 7 days after electrode implantation (test period)

• Proportion of subjects of ideal pain state

  Every day for 7 days after electrode implantation (test period), every day from 7 to 14 days after electrode implantation (randomized withdrawal period), and every day from 14 to 28 days after electrode implantation (observation period)

• Sleep-related assessment after electrostimulation

  Every day for 7 days after electrode implantation (test period), every day from 7 to 14 days after electrode implantation (randomized withdrawal period), and every day from 14 to 28 days after electrode implantation (observation period)

• Change of life quality after electrostimulation

  4 days before electrode implantation, 7, 14, 21, 28 days after electrode implantation, and 14 days after electrode removal.

• Analgesic medications

  Every day from 4 days before electrode implantation to 14 days after electrode removal.

Study Arms (2)

Participants receiving active electrostimulation after implantation procedure

EXPERIMENTAL

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.

Device: Active electrostimulation

Participants receiving placebo electrostimulation after implantation procedure

PLACEBO COMPARATOR

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.

Device: Placebo electrostimulation

Interventions

Active electrostimulation DEVICE

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 active electrostimulation after implantation procedure

Placebo electrostimulation DEVICE

No actual electrostimulation

Participants receiving placebo electrostimulation after implantation procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• The Second People's Hospital of GuangDong Province: collaborator
• Xiamen Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Union Hospital, Tongji medical college, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 17258129 RESULT

• 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.

  PMID: 21422774 RESULT

• 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.

  PMID: 22151211 RESULT

• Slavin KV. Peripheral nerve stimulation for neuropathic pain. Neurotherapeutics. 2008 Jan;5(1):100-6. doi: 10.1016/j.nurt.2007.11.005.

  PMID: 18164488 RESULT

• 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.

  PMID: 30954936 RESULT

MeSH Terms

Conditions

Neuralgia, Postherpetic; Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases

Central Study Contacts

Dong Yang, PHD

CONTACT

13871230491; dongyang118@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 4, 2024
• Study Start: February 9, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)