Clinical trial NCT06893172: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postherpetic Neuralgia ( PHN )
Keywords: Warm acupuncture
Postherpetic Neuralgia
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The change of the Visual Analog Scale (VAS)
timeFrame: 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:
measure: Proportion of intervention-related adverse events
timeFrame: Up to four weeks
Other outcomes:
Locations:
Study officials:
References:
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