The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

NCT04560361 | Completed DMC

• 1 other identifier: 2020NL-103-02
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Postherpetic Neuralgia

Keywords

Electroacupuncture; Postherpetic Neuralgia; Analgesic effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in pain intensity (VAS)

  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

  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)

  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)

  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

  Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment

Study Arms (2)

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.

Other: Electroacupuncture treatment

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.

Other: Sham electroacupuncture treatment

Interventions

Electroacupuncture treatment OTHER

Continue the electroacupuncture treatment as described above for 30 minutes.

Electroacupuncture group

Sham electroacupuncture treatment OTHER

Continue the sham electroacupuncture treatment as described above for 30 minutes.

Sham electroacupuncture group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing University of Traditional Chinese Medicine: lead

Study Sites (7)

Huai'an Hospital of Traditional Chinese Medicine

Huai'an, Jiangsu, 223001, China

Location

Lianyungang Hospital of Traditional Chinese Medicine

Lianyungang, Jiangsu, 222004, China

Location

Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine

Nanjing, Jiangsu, 210001, China

Location

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, 210029, China

Location

Nantong Hospital of Traditional Chinese Medicine

Nantong, Jiangsu, 226001, China

Location

Shuyang Hospital of Traditional Chinese Medicine

Suqian, Jiangsu, 223600, China

Location

Wuxi Hospital of Traditional Chinese Medicine

Wuxi, Jiangsu, 214071, China

Location

Related Publications (8)

• 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.

  PMID: 24291734 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.

  PMID: 24916088 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.

  PMID: 32227773 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.

  PMID: 23551937 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.

  PMID: 31410050 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.

  PMID: 27804172 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.

  PMID: 21621130 BACKGROUND

• 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.

  PMID: 34254233 DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 23, 2020
• Study Start: October 14, 2020
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within six months after the trial complete
• Access Criteria: Use the EDC system of the Science and Technology Department of Jiangsu Provincial Hospital of Chinese Medicine to disclose the original data

Locations

CN (7)