The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

Study Overview
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Brief Summary
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The investigators designed the multicenter randomized parallel controlled clinical trial of electroacupuncture on PHN which is rigorously designed and have an appropriate sample size, aiming to evaluate the efficacy and safety of electroacupuncture in pain relieving and pain removing in the treatment of patients with PHN.

Detailed Description
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Postherpetic neuralgia(PHN) is the most common complication of herpes zoster, is a severe and intractable pain with a high incidence. Nearly 50% of PHN patients have experienced persistent pain for more than one year. Although it is not directly life-threatening, will lead to sleep disorders, even depression, seriously affecting the quality of life of patients. This project is a multi-center randomized controlled trial, which will recruit 448 patients with PHN in 7 hospitals, aiming to evaluate the analgesic effect and safety of electroacupuncture on postherpetic neuralgia, and provide evidence-based medical evidence for electroacupuncture treatment of PHN.

Official Title
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The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: a Multicenter Randomized Controlled Trial

Conditions
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Postherpetic Neuralgia

Intervention / Treatment
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* Other: Electroacupuncture treatment
* Other: Sham electroacupuncture treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet the diagnostic criteria for postherpetic neuralgia (with a clear history of acute herpes zoster, and the duration of postherpetic pain exceeds 90 days) Aged 45 to 75 years old Patients who were diagnosed with moderate or above pain during the observation period (the daily pain score was continuously collected within 7 days during the observation period, and the average NRS-11 pain score was >=4) Subjects who did not participate in other ongoing clinical studies Sign informed consent and volunteer to participate in the study Exclusion Criteria: Patients who are currently receiving or receiving more than one of the permitted combinations or any prohibited combination and treatment for PHN listed in the following part at least 14 days before screening, and are unwilling to undergo washout period, or patients with serious safety problems during washout period or observation period Patients who are expected to receive any new prescription drug or other treatment for PHN after the start of the trial Patients with serious uncontrolled medical conditions, such as cardiovascular, lung, liver, kidney, gastrointestinal tract, metabolism, endocrine, nervous system, respiratory system, urogenital system and other serious diseases, or systemic organ dysfunction, malignant tumor, hematologic disease such as bleeding tendency or coagulation dysfunction, serious mental illness such as depression or schizophrenia Symptoms, hepatitis B antigen or hepatitis C antibody positive known state or history of immune dysfunction, history of HIV infection, etc. Patients with severe pain unrelated to PHN, such as after surgery for clinical major diseases Patients with PHN who have received nerve intervention or other neurosurgical treatment, such as selective nerve damage, percutaneous radiofrequency thermocoagulation or pulsed nerve modulation technology, etc. Patients with some special types of herpes zoster, such as those with meninges, cornea, conjunctiva, ear involvement, visceral herpes zoster, generalized herpes zoster Patients with skin ulceration, new herpes, or skin infection Patients with cardiac pacemaker, metal allergy or severe fear of needle Patients who are unable to give full informed consent or cannot cooperate with pain scale assessment due to mental, mental, linguistic or behavioral disorders Patients who have poor compliance or are prone to fall off due to other reasons, such as the current residence is not in the city where the recruitment hospital is located, or the working environment changes frequently Pregnant and lactating women

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using the center stratification block randomization method, the center is used as the stratification factor, and subjects were randomly assigned to the electroacupuncture group and the sham electroacupuncture group at a ratio of 1:1. The central randomization system is used for randomization operations.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture group<br>Choose the appropriate position according to the patient's herpes site, and routinely disinfect the skin. Paste the fixed insulating pad on the acupoint, and use a 0.30×40mm acupuncture needle to penetrate the skin 10mm obliquely through the fixed insulating gasket at Ashi point; According to the above operation, the SJ6 and GB34 point of the affected side are directly penetrated into the skin 15-20mm. The local Ashi point connects the two poles of the electroacupuncture device according to the first and last points of the long axis of the painful part, and the SJ6 and GB34 point on the affected side are connected to the poles of the electroacupuncture device. Electroacupuncture waveform is continuous wave, frequency is 2Hz, and current intensity is 1-5mA (causing slight tremor of the skin around the acupuncture point without pain). Continue the electroacupuncture treatment for 30 minutes. | Other: Electroacupuncture treatment<br>* Continue the electroacupuncture treatment as described above for 30 minutes.<br>|
| Sham Comparator: Sham electroacupuncture group<br>Participants randomly assigned to the sham electroacupuncture (SA) group received sham electroacupuncture by using placebo blunt needles at the same acupoints. After disinfecting the skin and placing the sterile insulating adhesive pads on unilateral Zhigou, Yanglingquan and Ashi points, placebo blunt needles are inserted through the pads and reach the insulating adhesive layer, causing the participants to feel the needle resistance (a sensation of needle insertion). Other procedures, electrode placements, parameter of electroacupuncture apparatus and treatment settings are the same as in the EA group, but with no skin penetration or electricity output. | Other: Sham electroacupuncture treatment<br>* Continue the sham electroacupuncture treatment as described above for 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity (NRS-11) | 11-point numeric rating scale (NRS-11): range from 0 (no pain) to 10 (worst possible pain), with 1-3 points representing mild pain, 4-6 points representing moderate pain, and 7-10 points representing severe pain. A reduction of ≥30% in NRS-11 scores from baseline were considered responders. | Change from Baseline at 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity (VAS) | Visual analogue scale (VAS): a horizontal line without verbal descriptors or numbers at intermediate points (0=no pain, 10=worst imaginable pain) | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment | 
| Change in the interference of pain on sleep | Verbal rating scale (VRS): 4 levels. Level 0: No pain. Level I (mild): Pain but tolerable, normal life, no interference with sleep. Level II (moderate): Pain is obvious, unbearable, requires analgesic medication, and sleep is disturbed. Level III: Severe pain, unbearable, analgesic medication, severe interference with sleep, accompanied by autonomic dysfunction or passive positions. | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment | 
| Change in mechanical pain threshold (MPT) | Stimulated the most painful central part of PHN with a series of von Frey hairs (0.008-300 g). | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment | 
| Change in pain area of PHN (PAP) | calculated by the researcher based on 45 body areas rating scale (BARS-45) which requires the use of height and weight of the patient. | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment | 
| Change in average number of pain episodes per day | Painless: 0 times; Intermittent pain: 1-50 times (1-2, 3-5, 6-10, 11-50 optional); Persistent pain: >50 times. | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment | 
| Change in average duration of each pain episode (ADEPE) | Duration ranges from 0 minutes (no pain) to 24 hours (persistent pain). | Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment | 
| Change in the nature and intensity of pain | short form of McGill pain questionnaire 2 (SF-MPQ-2): includes 22 items. | Change from Baseline at 4 weeks after treatment | 
| Change in degree of pain and its impact on work life, interpersonal relationships and sleep | Zoster brief pain inventory (ZBPI) | Change from Baseline at 4 weeks after treatment | 
| Change in depression, anxiety and positive outlook scale (DAPOS) | 11 items, combines depression (5 items), anxiety (3 items) and positive outlook (3 items). | Change from Baseline at 4 weeks after treatment | 
| Change in overall impression of PHN | Patient global impression of change (PGIC): Participants were asked to describe their overall impression of change of their condition/pain by answering the following question: Compared to your pain at admission to the project, how much has it changed? (categories: much improved = 1, mildly improved = 2, unchanged = 3, mildly worsened = 4, much worsened = 5). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroacupuncture, Postherpetic Neuralgia, Analgesic effect