Effectiveness of Warm Acupuncture in Patients with Postherpetic Neuralgia

Official title

Effectiveness of Warm Acupuncture for Postherpetic Neuralgia in the Context of the Qi Stagnation and Blood Stasis Syndrome: a Randomized Controlled Trial

Overview

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.

Detailed description

Patients with Postherpetic neuralgia in the trunk area, belonging to the Blood Stasis syndrome. They will be treated with a combination of Warm Acupuncture and Gabapentin.

The intervention period is four weeks. Warm Acupuncture will be performed five times a week and Gabapentin is administered daily for 4 weeks.

Data on the Visual Analog Scale (VAS), and side effects of Warm Acupuncture and Gabapentin will be recorded before the study and weekly for 4 weeks.

Interventions

• Other Warm acupuncture and Gabapentin
  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.
• Drug Gabapentin
  This group used gabapentin 300mg per tablet, twice a day, for a treatment period of 4 weeks

Primary outcome measures

• The change of the Visual Analog Scale (VAS) [Time frame: 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 outcome measures (1)

• Proportion of intervention-related adverse events [Time frame: Up to four weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06893172 · 1705/DHYD-HDDD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗