Effectiveness of Warm Acupuncture in Patients with Postherpetic Neuralgia

NCT06893172 | Not Yet Recruiting DMC

• 1 other identifier: 1705/DHYD-HDDD
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postherpetic neuralgia (PHN) is the most common clinical complication of herpes zoster. PHN can persist for months to years, and in some cases, the pain may last for more than five years. Patients suffering from severe, prolonged pain endure significant distress, which seriously affects their quality of life and daily activities. Moreover, PHN can lead to insomnia, anxiety, depression, or even suicide. Currently, the treatment of PHN primarily focuses on pain management. First-line treatment options include gabapentin, pregabalin, tricyclic antidepressants, and 5% lidocaine patches. Acupuncture is a widely used non-pharmacological therapy. A large number of clinical trials have demonstrated its effectiveness in treating various neuropathic pain conditions, including PHN. Acupuncture not only reduces pain perception but also alleviates anxiety and improves the quality of life for PHN patients. Among different acupuncture techniques, Warm Acupuncture (WA) is considered the most effective for treating peripheral neuropathic pain. Clinical case reports have also shown its pain-relieving effects in PHN patients. However, there has been no study in Vietnam on the effectiveness of WA in pain reduction for patients with PHN. Therefore, this study is conducted to evaluate whether WA is effective in reducing pain and ensuring safety for treating PHN patients with Qi Stagnation and Blood Stasis syndrome. The findings will serve as a basis for the broader application of WA in the treatment of PHN.

Conditions

Postherpetic Neuralgia ( PHN )

Keywords

Warm acupuncture; Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• The change of the Visual Analog Scale (VAS)

  Pain will be measured using the Visual Analog Scale (VAS). Patients will be asked to circle a number from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain.

  Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)

Secondary Outcomes (1)

• Proportion of intervention-related adverse events

  Up to four weeks

Study Arms (2)

Study Group

EXPERIMENTAL

The study group used gabapentin 300mg per tablet, twice a day, for a treatment period of 4 weeks, combined with Warm acupuncture at the Ashi point, EX-B2, LI4, TE6, PC5 and SP6, five times a week for 4 weeks.

Other: Warm acupuncture and Gabapentin

Control Group

ACTIVE COMPARATOR

The control group used gabapentin 300mg per tablet, twice a day, for a treatment period of 4 weeks

Drug: Gabapentin

Interventions

Warm acupuncture and Gabapentin OTHER

This group used gabapentin 300mg per tablet, twice a day, for a treatment period of 4 weeks, combined with warm acupuncture at the Ashi point, EX-B2, LI4, TE6, PC5 and SP6, five times a week for 4 weeks.

Study Group

Gabapentin DRUG

This group used gabapentin 300mg per tablet, twice a day, for a treatment period of 4 weeks

Control Group

Eligibility Criteria

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

You may qualify if:

• Individuals with a history of herpes zoster in the trunk area.
• Individuals diagnosed with Postherpetic neuralgia (PHN) by a dermatologist, based on PHN diagnostic criteria, with pain persisting for 3 months or more after the skin lesions have healed.
• Individuals with a pain intensity score of ≥ 3, assessed using the Visual Analog Scale (VAS).
• Individuals diagnosed with Qi Stagnation and Blood Stasis syndrome by a Traditional Medicine doctor.
• Individuals aged 18 years or older.
• Individuals who volunteer to participate in the study and sign a consent form.

You may not qualify if:

• Active herpes zoster lesions, confirmed by the dermatologist treating the patient.
• Pregnant or breastfeeding women.
• Patients with severe cognitive impairment who cannot understand the study protocol.
• Patients with a history of allergy to Gabapentin.
• Currently participating in another interventional study.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Related Publications (15)

• Zhao H, Nie W, Sun Y, Li S, Yang S, Meng F, Zhang L, Wang F, Huang S. Warm Needling Therapy and Acupuncture at Meridian-Sinew Sites Based on the Meridian-Sinew Theory: Hemiplegic Shoulder Pain. Evid Based Complement Alternat Med. 2015;2015:694973. doi: 10.1155/2015/694973. Epub 2015 Oct 1.

  PMID: 26495023 BACKGROUND

• Li X, Han Y, Cui J, Yuan P, Di Z, Li L. Efficacy of Warm Needle Moxibustion on Lumbar Disc Herniation: A Meta-Analysis. J Evid Based Complementary Altern Med. 2016 Oct;21(4):311-9. doi: 10.1177/2156587215605419. Epub 2015 Sep 15.

  PMID: 26378088 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

• Zhao W, Huang H, Liu K, Wang S, Lin S, Long W, Li L, Zeng J, Lin G. Acupuncture and Moxibustion for Peripheral Neuropathic Pain: A Frequentist Network Meta-Analysis and Cost-Effectiveness Evaluation. Evid Based Complement Alternat Med. 2022 Mar 16;2022:6886465. doi: 10.1155/2022/6886465. eCollection 2022.

  PMID: 35341147 BACKGROUND

• He K, Hu R, Huang Y, Qiu B, Chen Q, Ma R. Effects of Acupuncture on Neuropathic Pain Induced by Spinal Cord Injury: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2022 Aug 19;2022:6297484. doi: 10.1155/2022/6297484. eCollection 2022.

  PMID: 36034938 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

• 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

• Zhang M, Gao CX, Ma KT, Li L, Dai ZG, Wang S, Si JQ. A Meta-Analysis of Therapeutic Efficacy and Safety of Gabapentin in the Treatment of Postherpetic Neuralgia from Randomized Controlled Trials. Biomed Res Int. 2018 Jul 4;2018:7474207. doi: 10.1155/2018/7474207. eCollection 2018.

  PMID: 30069477 BACKGROUND

• Du J, Sun G, Ma H, Xiang P, Guo Y, Deng Y, Li S, Li X. Prevalence and Risk Factors of Anxiety and Depression in Patients with Postherpetic Neuralgia: A Retrospective Study. Dermatology. 2021;237(6):891-895. doi: 10.1159/000512190. Epub 2020 Dec 16.

  PMID: 33326962 BACKGROUND

• Putri Mellaratna W, Jusuf NK, Yosi A. The impact of pain intensity on quality of life of postherpetic neuralgia patients. Med Glas (Zenica). 2020 Aug 1;17(2):439-444. doi: 10.17392/1111-20.

  PMID: 32253903 BACKGROUND

• Yang F, Yu S, Fan B, Liu Y, Chen YX, Kudel I, Concialdi K, DiBonaventura M, Hopps M, Hlavacek P, Cappelleri JC, Sadosky A, Parsons B, Udall M. The Epidemiology of Herpes Zoster and Postherpetic Neuralgia in China: Results from a Cross-Sectional Study. Pain Ther. 2019 Dec;8(2):249-259. doi: 10.1007/s40122-019-0127-z. Epub 2019 Jun 19.

  PMID: 31218562 BACKGROUND

• Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008 Jun 6;57(RR-5):1-30; quiz CE2-4.

  PMID: 18528318 BACKGROUND

• Lin YH, Huang LM, Chang IS, Tsai FY, Lu CY, Shao PL, Chang LY; Varicella-Zoster Working Group; Advisory Committee on Immunization Practices, Taiwan. Disease burden and epidemiology of herpes zoster in pre-vaccine Taiwan. Vaccine. 2010 Feb 3;28(5):1217-20. doi: 10.1016/j.vaccine.2009.11.029. Epub 2009 Nov 26.

  PMID: 19944790 BACKGROUND

• Chen LK, Arai H, Chen LY, Chou MY, Djauzi S, Dong B, Kojima T, Kwon KT, Leong HN, Leung EM, Liang CK, Liu X, Mathai D, Pan JY, Peng LN, Poblete ER, Poi PJ, Reid S, Tantawichien T, Won CW. Looking back to move forward: a twenty-year audit of herpes zoster in Asia-Pacific. BMC Infect Dis. 2017 Mar 15;17(1):213. doi: 10.1186/s12879-017-2198-y.

  PMID: 28298208 BACKGROUND

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Quyen Le Bao Nguyen

CONTACT

+84981864951; baoquyen2397@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03