An interventional study of Electroacupuncture treatment and Sham electroacupuncture treatment in Postherpetic Neuralgia, sponsored by Nanjing University of Traditional Chinese Medicine. Completed at 7 sites in China. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Nanjing University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
Continue the electroacupuncture treatment as described above for 30 minutes.
Continue the sham electroacupuncture treatment as described above for 30 minutes.
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.
Time frame: Change from Baseline at 4 weeks after treatment
Change in pain intensity (NRS-11)
The NRS-11 score ranges 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.
Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 1-month follow-up.
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)
Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.
Interference of pain on sleep
Verbal rating scale (VRS): 4 levels. 1. Level 0: No pain. 2. Level I (mild): Pain but tolerable, normal life, no interference with sleep. 3. Level II (moderate): Pain is obvious, unbearable, requires analgesic medication, and sleep is disturbed. 4. Level III: Severe pain, unbearable, analgesic medication, severe interference with sleep, accompanied by autonomic dysfunction or passive positions.
Time frame: 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.
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).
Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.
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.
Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.
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.
Time frame: 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.
Average duration of each pain episode (ADEPE)
Duration ranges from 0 minutes (no pain) to 24 hours (persistent pain).
Time frame: 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment and 1-month follow-up.
Change in the nature and intensity of pain
short form of McGill pain questionnaire 2 (SF-MPQ-2): includes 22 items.
Time frame: Change from Baseline at 4 weeks after treatment and 1-month follow-up.
Change in degree of pain and its impact on work life, interpersonal relationships and sleep
Zoster brief pain inventory (ZBPI)
Time frame: Change from Baseline at 4 weeks after treatment and 1-month follow-up.
Change in depression, anxiety and positive outlook scale (DAPOS)
11 items, combines depression (5 items), anxiety (3 items) and positive outlook (3 items).
Time frame: Change from Baseline at 4 weeks after treatment and 1-month follow-up.
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).
Time frame: Week 4 and week 8.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Case Report Form, Electronic Data Capture(EDC)
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Nanjing University of Traditional Chinese Medicine