Evaluating Peripheral Nerve Stimulation for Postherpetic Neuralgia

Prospective, Multicentre, Randomised Withdrawal Design of a Clinical Trial Evaluating the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System for Patients With Peripheral Neuropathic Pain.

This study is testing if a new nerve stimulation treatment can help people with postherpetic neuralgia manage their pain better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06290661 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of percutaneous peripheral nerve stimulation in patients suffering from postherpetic neuralgia. Participants will undergo the implantation of a nerve stimulation electrode and will be randomly assigned to either an active stimulation group or a placebo group based on their pain reduction. The study will involve a baseline assessment, followed by a treatment period where stimulation parameters will be adjusted, and a follow-up period where participants will track their pain levels and medication use. The trial is conducted across four clinical sites in China, enrolling a total of 56 subjects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with postherpetic neuralgia who have not found relief from conventional treatments.

Not a fit: Patients requiring simultaneous treatments like radio frequency modulation or those with existing cardiac implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients with postherpetic neuralgia.

How similar studies have performed: While this approach is being explored, the specific application of peripheral nerve stimulation for postherpetic neuralgia is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji medical college, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Dong Yang, PHD

Conditions Postherpetic Neuralgia; Peripheral Neuropathic Pain; Trigeminal Neuralgia; Peripheral Nerve Stimulation; peripheral neuropathic pain