Evaluate the Safety and Efficacy of a Peripheral Nerve Stimulation

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 trial was conducted in a prospective, multicenter, randomized withdrawal design at a designated clinical trial facility. The total sample size for this trial is expected to be 59-62 patients.

One to two subjects were conducted in each study center as a preliminary test. A total of about 3-6 subjects were selected for the pre-test. The pre-test subjects used the test equipment (on state) and were not randomized.

The study was divided into screening/baseline period, treatment period (including test period, random withdrawal period and observation period) and follow-up period.

All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent Peripheral Nerve Stimulation(PNS) surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.

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.