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NCT Number: NCT06893172

Effectiveness of Warm Acupuncture in Patients with Postherpetic Neuralgia

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.

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Key information

Conditions

Postherpetic Neuralgia ( PHN ) Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Gabapentin

Drug

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

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Proportion of intervention-related adverse events

    Time frame: Up to four weeks

    While Warm acupuncture is generally considered safe, some patients may experience minor side effects at the application site. Studies on Warm Acupuncture have reported negligible adverse effects. The recorded adverse effects include burns, pain at the acupuncture site, and bleeding at the acupuncture site. The study will closely monitor and document any unexpected adverse events associated with the procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Quyen Le Bao Nguyen

CONTACT

[email protected]

+84981864951

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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