Effectiveness of Warm Acupuncture in Patients with Postherpetic Neuralgia

March 18, 2025 updated by: Dang Ngoc Ha Phuong, University of Medicine and Pharmacy at Ho Chi Minh City

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
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
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.
Active Comparator: Control Group
The control group used gabapentin 300mg per tablet, twice a day, for a treatment period of 4 weeks
Drug: Gabapentin
This group used gabapentin 300mg per tablet, twice a day, for a treatment period of 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Outcome Measure
Measure Description
Time Frame
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.
Up to four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

August 29, 2025

Study Completion (Estimated)

August 29, 2025

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1705/DHYD-HDDD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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