Effectiveness of Warm Acupuncture in Patients with Postherpetic Neuralgia

Not Applicable

Not yet recruiting

• Conditions: Postherpetic Neuralgia ( PHN )
• Interventions: Other: Warm acupuncture and Gabapentin; Drug: Gabapentin

• Registration Number: NCT06893172
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

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.

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-04-01
• Primary Completion: 2025-08-29
• Study Completion: 2025-08-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Warm acupuncture and Gabapentin	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.
Control Group	Gabapentin	The control group used gabapentin 300mg per tablet, twice a day, for a treatment period of 4 weeks

Primary Outcome Measures

Name	Time	Method
The change of the Visual Analog Scale (VAS)	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 Outcome Measures

Name	Time	Method
Proportion of intervention-related adverse events	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.