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.
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;
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;
Parallel
Active electrostimulation
DeviceMaintain the electrical stimulation state, and according to the patient's feeling to set the appropriate stimulation parameter range (pain relief and no obvious numbness and discomfort), the programme will be written into the patient's self-control remote control, by the patient according to their own pain situation for the independent control of the stimulation current.
Placebo electrostimulation
DeviceNo actual electrostimulation
Difference in mean pain visual analogue scale VAS scores between trial and control groups in the randomised withdrawal period
Researchers will collect visual analogue scale scores of 7 days after the implantation of peripheral nerve stimulation electrode to calculate mean scores of 4 days before randomized withdrawal and evaluate the difference in pain improvement of peripheral nerve stimulation between the two groups (trial and control group) by analyzing the mean change in VAS scores during randomized withdrawal period.
Visual simulation assessment scale collects pain scores after peripheral electrode placement
Researchers collected daily pain scores from the day of peripheral nerve stimulation electrode implantation until removal using the VAS pain scale, as well as pain scores on the 14th day after electrode removal.
Proportion of subjects whose pain relief more than 30%
The VAS scores recorded in pain diary by participants during randomized withdrawal period decreased more 30% than baseline period.
Proportion of subjects of ideal pain state
The VAS scores recorded in pain diary by participants during test period, randomized withdrawal period and observation period less than forty millimeters.
Sleep-related assessment after electrostimulation
The number of awakenings in sleep diary by participants during test period, randomized withdrawal period and observation period.
Change of life quality after electrostimulation
The subjects will be asked to fulfill the Mos 36-item Short Form Health Survey with assistance of clinical physician.
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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
