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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
448
Continue the electroacupuncture treatment as described above for 30 minutes.
Continue the sham electroacupuncture treatment as described above for 30 minutes.
Huai'an Hospital of Traditional Chinese Medicine
Huai'an, Jiangsu, China
Lianyungang Hospital of Traditional Chinese Medicine
Lianyungang, Jiangsu, China
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Jiangsu Province Hospital of Chinese Medicine
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.
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Nanjing, Jiangsu, China
Nantong Hospital of Traditional Chinese Medicine
Nantong, Jiangsu, China
Shuyang Hospital of Traditional Chinese Medicine
Suqian, Jiangsu, China
Wuxi Hospital of Traditional Chinese Medicine
Wuxi, Jiangsu, China
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.