Evaluating a new method for relieving peripheral nerve pain

A Prospective, Multicenter, Randomized Withdrawal Trial to Evaluate the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System in Patients With Peripheral Neuropathic Pain

This study is testing a new nerve stimulation method to see if it can help people with long-lasting nerve pain feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05827848 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of a peripheral nerve stimulation system for patients suffering from chronic and refractory peripheral neuropathic pain. The study employs a multicenter, randomized withdrawal design, involving a total of approximately 59-62 patients. Participants will undergo a baseline assessment followed by a treatment period where they will receive the peripheral nerve stimulation surgery and be monitored for pain relief. The effectiveness of the treatment will be evaluated based on improvements in visual analogue scale (VAS) scores.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic peripheral neuropathic pain that has not improved with standard treatments.

Not a fit: Patients requiring alternative treatments such as radiofrequency regulation or those with heart implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic nerve pain for patients who have not responded to conventional therapies.

How similar studies have performed: Previous studies on peripheral nerve stimulation have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years old, gender unlimited;
* The investigator judged that there was definite peripheral neuropathic pain (chronic and refractory pain in the trunk and extremities, including chronic pain after sternal surgery; Postherpetic neuralgia), suitable for percutaneous peripheral nerve stimulation system treatment;
* Preoperative assessment by neuropathic Pain Scale (DN4) showed that there were related damages or diseases in the peripheral sensory system;
* Patients with poor efficacy or can not tolerate the side effects of treatment after routine treatment;
* Visual analogue scale (VAS)≥50mm within 24 hours before treatment;
* The subject can understand the study purpose, demonstrate sufficient compliance with the study protocol, and be able and willing to sign the informed consent.

Exclusion Criteria:

* Patients who need to be treated with radiofrequency regulation and intrathecal drug infusion;
* Patients who are known to have had heart implants (pacemakers or defibrillators) or other implanted neurostimulators (spinal cord stimulators or deep brain stimulators, etc.);
* Patients with severe psychological and/or psychiatric illness and/or non-therapeutic drug dependence;
* Patients who are expected to undergo MRI within 30 days after PNS implantation;
* Expected to be discharged within 48 hours or less;
* There is known damage to the target nerve or muscle defect in the pain area;
* Patients with known allergies to skin-to-skin contact materials (tape or adhesive);
* Known allergy to anesthetics such as lidocaine;
* Preoperative complications of severe heart, liver, kidney, respiratory diseases and coagulopathy;
* Pregnant or lactating women, or have a birth plan in the next 3 months;
* Is participating in any other drug or medical device clinical trial, or may participate in any other drug or medical device clinical trial after enrollment in this clinical trial;
* The investigator determined that there were other conditions that were not suitable to participate in the clinical trial.

Where this trial is running

Shanghai, Shanghai

• Ke Ma, PhD — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Ke Ma, PhD

Conditions: Complications, Prosthesis, Nervous System, Peripheral, Pain, Peripheral nerve pain