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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Ke Ma, PhD
RECRUITING
Shanghai
Contact Information
Primary
Ke Ma, PhD
marke72@163.com
86-21-25078707
Time Frame
Start Date: 2022-10-28
Estimated Completion Date: 2024-12-01
Participants
Target number of participants: 62
Treatments
Experimental: Treatment group
Turn on the machine for continuous nerve stimulation
No_intervention: control group
Turn off the machine
Related Therapeutic Areas
Sponsors
Leads: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov

Similar Clinical Trials