evaluate the safety and efficacy of a peripheral nerve stimulation

Conditions: Complications; Prosthesis, Nervous System, Peripheral, Pain

Summary: 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.


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.

Keywords: peripheral nerve pain