Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

The goal of this clinical trial is to evaluate safety and efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain. The main questions it aims to answer are:

1. The efficacy of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain 2. The safety of percutaneous peripheral nerve stimulation in patients with peripheral neuropathic pain Participants are going to undergo procedure that implant peripheral nerve stimulation electrode produced by Jiangsu CED Medtech Co., Ltd. Then the subjects, whose VAS scores decrease more 30% than baseline level, are classified into two groups randomly. One of the group receiving active stimulation called trial group and another receiving placebo stimulation called control group. All subjects are required to make their own subjects' pain diary to record VSA score before and after implantation until at the end of follow-up. Also, participants are asked to report use of analgesic medications, number of awakenings and adverse events.

Researchers will compare pain scores between the two groups to see if peripheral nerve stimulation is effective to patients with peripheral neuropathic pain.

Eligibility criteria

Qualifiers

18 years old and above, male or female

Diagnosed by trained clinical doctors as postherpetic neuralgia, which is an indication for peripheral nerve stimulation therapy;

Assess the damage or disease of the peripheral sensory system through the four questions of Douleur Neuropathy before surgery;

The subject has received conventional treatment but the efficacy is poor, or cannot tolerate the side effects of conventional treatment;

Disqualifiers

Subjects who need to receive both radio frequency modulation and intrathecal drug infusion treatment simultaneously;

Subjects who are known to have cardiac implants (pacemakers or defibrillators) or other implantable neural stimulators (spinal cord stimulators or deep brain stimulators, etc.);

Subjects with severe psychological and/or mental disorders and/or non therapeutic drug dependence;

Subjects expected to undergo MRI examination within 30 days after PNS implantation;

Trial design

Treatments tested in this trial

  • Active electrostimulation
  • Placebo electrostimulation

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

The Second People's Hospital of GuangDong Province

Collaborator

Xiamen Hospital of Traditional Chinese Medicine

Collaborator