The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

NCT ID: NCT04560361

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 448 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2022-08-23

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.

Detailed Description

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.

Conditions

Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Electroacupuncture group

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.

Group Type: EXPERIMENTAL

Electroacupuncture treatment

Intervention Type: OTHER

Continue the electroacupuncture treatment as described above for 30 minutes.

Sham electroacupuncture group

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.

Group Type: SHAM_COMPARATOR

Sham electroacupuncture treatment

Intervention Type: OTHER

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

Interventions

Electroacupuncture treatment

Continue the electroacupuncture treatment as described above for 30 minutes.

Intervention Type: OTHER

Sham electroacupuncture treatment

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Qianyan Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianhua Sun

Role: STUDY_DIRECTOR

Jiangsu Province Hospital of Traditional Chinese Medicine

Wenping Yao

Role: PRINCIPAL_INVESTIGATOR

Lianyungang Hospital of Traditional Chinese Medicine

Yongtao Liu

Role: PRINCIPAL_INVESTIGATOR

Huai'an Hospital of Traditional Chinese Medicine

Juanjuan Shi

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Nanjing University of Chinese Medicine

Hua Feng

Role: PRINCIPAL_INVESTIGATOR

Wuxi Hospital of Traditional Chinese Medicine

Chunxia Lu

Role: PRINCIPAL_INVESTIGATOR

Nantong Hospital of Traditional Chinese Medicine

Yanfang Liu

Role: PRINCIPAL_INVESTIGATOR

Shuyang Hospital of Traditional Chinese Medicine

Locations

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

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

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 32227773 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24291734 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24916088 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23551937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31410050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27804172 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21621130 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34254233 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2020NL-103-02

Identifier Type: -

Identifier Source: org_study_id