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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture group | Experimental | 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. |
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| Sham electroacupuncture group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture treatment | Other | Continue the electroacupuncture treatment as described above for 30 minutes. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianhua Sun | Jiangsu Province Hospital of Traditional Chinese Medicine | Study Director |
| Wenping Yao | Lianyungang Hospital of Traditional Chinese Medicine | Principal Investigator |
| Yongtao Liu | Huai'an Hospital of Traditional Chinese Medicine | Principal Investigator |
| Juanjuan Shi | Affiliated Hospital of Nanjing University of Chinese Medicine | Principal Investigator |
| Hua Feng | Wuxi Hospital of Traditional Chinese Medicine | Principal Investigator |
| Chunxia Lu | Nantong Hospital of Traditional Chinese Medicine | Principal Investigator |
| Yanfang Liu | Shuyang Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huai'an Hospital of Traditional Chinese Medicine | Huai'an | Jiangsu | 223001 | China | ||
| Lianyungang Hospital of Traditional Chinese Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24291734 | Background | van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain. 2014 Apr;155(4):654-662. doi: 10.1016/j.pain.2013.11.013. Epub 2013 Nov 26. | |
| 24916088 | Background | Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014 Jun 10;4(6):e004833. doi: 10.1136/bmjopen-2014-004833. |
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Case Report Form, Electronic Data Capture(EDC)
Within six months after the trial complete
Use the EDC system of the Science and Technology Department of Jiangsu Provincial Hospital of Chinese Medicine to disclose the original data
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2021 | Apr 12, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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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.
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The randomization scheme is generated, validated and imported into the central randomization system by a statistician who do not participate in this trial by using R software. The central randomization system has set strict personnel permissions, and no one has right to view the randomization scheme except the highest-level system administrator. Patients and study investigators (i.e., outcome assessors, data recorders, data entry clerks and statistical analysts) will be blinded to the group assignment. Due to the nature of the intervention, acupuncturists will not be blinded to the treatment.
| Sham electroacupuncture treatment | Other | Continue the sham electroacupuncture treatment as described above for 30 minutes. |
|
Verbal rating scale (VRS): 4 levels.
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| 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 |
| Lianyungang |
| Jiangsu |
| 222004 |
| China |
| Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine | Nanjing | Jiangsu | 210001 | China |
| Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu | 210029 | China |
| Nantong Hospital of Traditional Chinese Medicine | Nantong | Jiangsu | 226001 | China |
| Shuyang Hospital of Traditional Chinese Medicine | Suqian | Jiangsu | 223600 | China |
| Wuxi Hospital of Traditional Chinese Medicine | Wuxi | Jiangsu | 214071 | China |
| 32227773 | Background | Wang L, Qiu L, Zheng X, Ouyang J, Zhang M, He L, Zeng S, Liu B, Peng J. Effectiveness of electroacupuncture at Jiaji acupoints (EX-B2), plus moxibustion and intermediate on postherpetic neuralgia: a randomized controlled trial. J Tradit Chin Med. 2020 Feb;40(1):121-127. |
| 23551937 | Background | Wu CH, Lv ZT, Zhao Y, Gao Y, Li JQ, Gao F, Meng XF, Tian B, Shi J, Pan HL, Li M. Electroacupuncture improves thermal and mechanical sensitivities in a rat model of postherpetic neuralgia. Mol Pain. 2013 Apr 3;9:18. doi: 10.1186/1744-8069-9-18. |
| 31410050 | Background | Pei W, Zeng J, Lu L, Lin G, Ruan J. Is acupuncture an effective postherpetic neuralgia treatment? A systematic review and meta-analysis. J Pain Res. 2019 Jul 16;12:2155-2165. doi: 10.2147/JPR.S199950. eCollection 2019. |
| 27804172 | Background | Werner RN, Nikkels AF, Marinovic B, Schafer M, Czarnecka-Operacz M, Agius AM, Bata-Csorgo Z, Breuer J, Girolomoni G, Gross GE, Langan S, Lapid-Gortzak R, Lesser TH, Pleyer U, Sellner J, Verjans GM, Wutzler P, Dressler C, Erdmann R, Rosumeck S, Nast A. European consensus-based (S2k) Guideline on the Management of Herpes Zoster - guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV), Part 1: Diagnosis. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):9-19. doi: 10.1111/jdv.13995. Epub 2016 Nov 2. |
| 21621130 | Background | Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016. |
| 42189557 | Derived | Chen L, Liu Q, Pei L, Geng H, Liu Y, Yang Z, Ding M, Shen R, Chen M, Lu J, You D, Wu X, Zhou J, Hu L, Guo B, Sun S, Chen F, Zhao Z, Zhai Y, Chen Z, Li Z, Yao W, Feng H, Lu C, Liu Y, Shi J, Guo J, Sun J. Effect of Electroacupuncture on Postherpetic Neuralgia: A Randomized Clinical Trial. JAMA Neurol. 2026 May 26:e261443. doi: 10.1001/jamaneurol.2026.1443. Online ahead of print. |
| 34254233 | Derived | Liu Q, Wu X, Guo J, Gao J, Liu B, Wang Y, Xia M, Pei L, Sun J. Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: A Trial Protocol for a Multicenter Randomized Controlled Trial. Pain Ther. 2021 Dec;10(2):1755-1771. doi: 10.1007/s40122-021-00283-8. Epub 2021 Jul 12. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |