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

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called peripheral nerve stimulation for people suffering from postherpetic neuralgia, a type of nerve pain that can occur after shingles. The main goals are to find out whether this treatment is safe and effective in reducing pain. Participants will have a small device implanted that sends gentle electrical signals to help manage their pain. After the procedure, participants will keep a diary to track their pain levels and any medications they use. They will be divided into two groups: one receiving the active treatment and the other receiving a placebo, which looks like the treatment but doesn’t provide any real effect.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with postherpetic neuralgia. They should have tried other treatments without much success, and their pain level must be moderate to severe. The trial is open to all genders, and participants will need to understand the study and agree to take part. This study is currently recruiting, so interested individuals should discuss it with their healthcare provider to see if it might be right for them.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 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;
• • Visual analogue scale for pain within 24 hours before surgery ≥ 5;
• • The subjects are able to understand the purpose of this study, have sufficient compliance with the research treatment, and are willing to sign an informed consent form;
• Exclusion criteria:
• • 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;
• • Expected to be discharged within 48 hours or less;
• • Target nerve damage or muscle defects in known pain areas;
• • Subjects who are known to be allergic to skin contact materials (tape or adhesive);
• • Allergy to anesthetics such as lidocaine;
• • Concomitant severe heart disease, liver disease, kidney disease, respiratory system disease, and coagulation dysfunction;
• • Pregnant women, lactating women, or women planning to have children within the next three months;
• • Subjects who have participated in any other clinical trial, or who may participate in any other trial after enrollment;
• • Other situations that the researcher deems unsuitable for participation in this clinical trial