Electroacupuncture Therapy for Treating Postherpetic Neuralgia

Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: a Multicentre Randomised Controlled Trial

Postherpetic neuralgia (PHN) has a high incidence rate and severely impact on quality of life and health care costs, interfering with physical, emotional and social functioning of affected patients. Current therapeutic options for PHN mainly include analgetic and local anaesthesia for selective nerve blockade. Nevertheless, the efficacy of analgetic is always limited by inevitable side effects, in which patients have poor compliance. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite the administration of complex combinations. As a non-pharmarceutical therapy, acupuncture is widely use for a wide range of pain conditions. Thus, it might be an alternative treatment for PHN. The aim of this multicenter randomized controlled trial is to investigate the efficacy and safety of electroacupuncture therapy in patients with postherpetic neuralgia.

Study Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Procedure: EA combined with medication; Drug: Medication

Detailed Description

This randomized controlled trial will enroll 132 patients with postherpetic neuralgia. All patients will be randomly assigned to either the EA combined with medication group or the medication group via a computerized central randomization system in a 1:1 ratio. Primary outcomes will be change in sensory thresholds and pain intensity. Secondary outcomes will be change in dosage of analgetic, quality of life, anxiety and depression severity and sleep quality.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • the Third Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients have a medical history of herpes zoster;
2. Skin lesion has healed in the region of herpes zoster, but the duration of postherpetic neuralgia persist for more than 30 days.
3. 20 ≤ age ≤80 years, male or female
4. Participants can fully understand the study protocol and written informed consent is signed.

Exclusion Criteria:

1. Acute herpes zoster, herpes zoster has not disappeared;
2. Herpes zoster belongs to a special type, such as ophthalmic herpes zoster, auricular herpes zoster, HZ that involves internal organs, meningeal herpes zoster, and disseminated herpes zoster.
3. Pregnant or lactating women;
4. Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems,or have malignant tumor, mental illness, immune deficiency, hemorrhagic disorders and other diseases;
5. Patients have severe cognitive impairment and can not understand the study protocol;
6. Patients can not receive electroacupuncture treatment due to any reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EA combined with medication group; Patients in this group will receive electroacupuncture combined with gabapentin.	Procedure: EA combined with medication; Primary acupoints include Ashi points, Jiaji acupoints and Xi-cleft points. Jiaji points on the ipsilateral side will be selected according to the corresponding ganglia involved by HZ. Xi-cleft points will be selected based on the distribution regions of PHN. For pain sites that mainly distributed in the gallbladder meridian, GB36 will be selected. For pain sites that mainly distributed in the stomach meridian, ST34 will be selected. For pain sites that mainly distributed in the gallbladder meridian, BL63 will be selected. For pain sites that mainly distributed in the large intestine meridian, LI7 will be selected. Supplementary acupoints will be chosen based on TCM syndrome differentiation. Operation: Two paired of acupoints are connected to the EA apparatus. EA parameter is selected as 2/100Hz wave. EA intensity is selected according to the patients' endurance. Needles will be retained and EA will last for 30 mins for each session.; Drug: Medication; The dosage of gabapentin starts from 100mg Tid. 100mg-300mg can be increased every 3-7 days and taken in three doses, but the total amount is not more than 1800mg/day. The dosage of gabapentin will be adjusted according to the patient's condition until his pain is effectively controlled. After maintaining the medication for two weeks, the dosage can be gradually reduced and 100mg can be reduced every 3-7 days.
Active Comparator: Medication group; Participants in this group will only receive gabapentin.	Drug: Medication; The dosage of gabapentin starts from 100mg Tid. 100mg-300mg can be increased every 3-7 days and taken in three doses, but the total amount is not more than 1800mg/day. The dosage of gabapentin will be adjusted according to the patient's condition until his pain is effectively controlled. After maintaining the medication for two weeks, the dosage can be gradually reduced and 100mg can be reduced every 3-7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sensory thresholds	Sensory thresholds is measured by quantitative sensory testing	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in pain intensity	Pain intensity is measured by Zoster Brief Pain Inventory (ZBPI)	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dosage of analgetic	Dosage of analgetic	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of quality of life	Quality of life is measure by 36-item Short Form Health Survey (SF-36)	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of anxiety and depression severity	Anxiety and depression severity is measure by Hospital Anxiety and Depression Scale (HADS)	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Change in score of sleep quality	Sleep quality is measured by Pittsburgh Sleep Quality Index (PSQI)	before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Adverse events	Incidence of adverse events	Up to 6 weeks of treatment

Collaborators and Investigators

• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Collaborators: Lishui Hospital of Traditional Chinese Medicine; Zhejiang Provincial Tongde Hospital
• Investigators: Principal Investigator: Dexiong Han, M.D, the Third Affiliated Hospital of Zhejiang Chinese Medical University

Publications and helpful links

General Publications

• Saguil A, Kane S, Mercado M, Lauters R. Herpes Zoster and Postherpetic Neuralgia: Prevention and Management. Am Fam Physician. 2017 Nov 15;96(10):656-663.
• Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. No abstract available.
• Forbes HJ, Thomas SL, Smeeth L, Clayton T, Farmer R, Bhaskaran K, Langan SM. A systematic review and meta-analysis of risk factors for postherpetic neuralgia. Pain. 2016 Jan;157(1):30-54. doi: 10.1097/j.pain.0000000000000307.
• Lin CS, Lin YC, Lao HC, Chen CC. Interventional Treatments for Postherpetic Neuralgia: A Systematic Review. Pain Physician. 2019 May;22(3):209-228.
• Wang Y, Li W, Peng W, Zhou J, Liu Z. Acupuncture for postherpetic neuralgia: Systematic review and meta-analysis. Medicine (Baltimore). 2018 Aug;97(34):e11986. doi: 10.1097/MD.0000000000011986.
• Avijgan M, Hajzargarbashi ST, Kamran A, Avijgan M. Postherpetic Neuralgia: Practical Experiences Return to Traditional Chinese Medicine. J Acupunct Meridian Stud. 2017 Jun;10(3):157-164. doi: 10.1016/j.jams.2017.02.003. Epub 2017 Feb 28.
• Ruengwongroj P, Muengtaweepongsa S, Patumanond J, Phinyo P. Effectiveness of press needle treatment and electroacupuncture in patients with postherpetic neuralgia: A matched propensity score analysis. Complement Ther Clin Pract. 2020 Aug;40:101202. doi: 10.1016/j.ctcp.2020.101202. Epub 2020 May 25.
• Zhang Y, Liang Z, Li S, Yang L, Guo T, Xu Y, Yang J, Xu Q, Zhang Q, Zhao J, Li C, Liu X. Fire needle plus cupping for acute herpes zoster: study protocol for a randomized controlled trial. Trials. 2020 Aug 6;21(1):701. doi: 10.1186/s13063-020-04599-2.
• 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.
• 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.
• Liu K, Zeng J, Pei W, Chen S, Luo Z, Lu L, Lin G. Assessing the reporting quality in randomized controlled trials of acupuncture for postherpetic neuralgia using the CONSORT statement and STRICTA guidelines. J Pain Res. 2019 Jul 29;12:2359-2370. doi: 10.2147/JPR.S210471. eCollection 2019.
• Hu H, Shen Y, Li X, Tian H, Li X, Li Y, Cheng Y, Wu L, Han D. Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial. Front Med (Lausanne). 2021 May 21;8:624797. doi: 10.3389/fmed.2021.624797. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 11, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Randomized controlled trial; Postherpetic neuralgia; Electroacupuncture; Protocol
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: 2019ZB057_

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No