Clinical trial NCT05827848: Evaluate the Safety and Efficacy of a Peripheral Nerve Stimulation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complications; Prosthesis, Nervous System, Peripheral, Pain
Keywords: Peripheral nerve pain
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Difference of the mean VAS scores of the experimental group and the control group during the random withdrawal period
timeFrame: 7 days after the wire implantation test period
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ke Ma, PhD
state: Shanghai
Study officials:
References: