Electroacupuncture Therapy for Treating Postherpetic Neuralgia

NCT04594226 | Completed DMC

• 1 other identifier: 2019ZB057_
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postherpetic Neuralgia

Keywords

Electroacupuncture; Postherpetic neuralgia; Pain; Randomized controlled trial; Protocol

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in 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

  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

  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

  before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up

• Adverse events

  Up to 6 weeks of treatment

Study Arms (2)

EA combined with medication group

EXPERIMENTAL

Patients in this group will receive electroacupuncture combined with gabapentin.

Procedure: EA combined with medication; Drug: Medication

Medication group

ACTIVE COMPARATOR

Participants in this group will only receive gabapentin.

Drug: Medication

Interventions

EA combined with medication PROCEDURE

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.

EA combined with medication group

Medication DRUG

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.

EA combined with medication group; Medication group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Acute herpes zoster, herpes zoster has not disappeared;
• 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.
• Pregnant or lactating women;
• 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;
• Patients have severe cognitive impairment and can not understand the study protocol;
• Patients can not receive electroacupuncture treatment due to any reasons.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead
• Lishui Hospital of Traditional Chinese Medicine: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (12)

• 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.

  PMID: 29431387 BACKGROUND

• 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.

  PMID: 25317872 BACKGROUND

• 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.

  PMID: 26218719 BACKGROUND

• Lin CS, Lin YC, Lao HC, Chen CC. Interventional Treatments for Postherpetic Neuralgia: A Systematic Review. Pain Physician. 2019 May;22(3):209-228.

  PMID: 31151330 BACKGROUND

• 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.

  PMID: 30142834 BACKGROUND

• 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.

  PMID: 28712474 BACKGROUND

• 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.

  PMID: 32891279 BACKGROUND

• 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.

  PMID: 32762718 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

• 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

• 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.

  PMID: 31534360 BACKGROUND

• 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.

  PMID: 34095161 DERIVED

MeSH Terms

Conditions

Neuralgia, Postherpetic; Pain

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Dexiong Han, M.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Acupuncture Department

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 20, 2020
• Study Start: November 11, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)