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Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol

NCT06261801 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-02-21

No results posted yet for this study

Summary

Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin.

Conditions

  • Trigeminal Herpetic Neuralgia

Interventions

OTHER

Medication Group

Participants in the medication group would take 150-mg pregabalin capsules (manufactured by Pfizer Pharmaceuticals Co., Ltd) orally twice daily (total daily dose, 300 mg) for 4 weeks.

OTHER

EA Group

Acupoints selection: Ashi acupoint, Sibai acupoint (ST2), Xiaguan acupoint (ST7), and Dicang acupoint (ST4) on the affected side. Acupoints for the diseased branches (all taken from the affected side): eye branch and Tongziliao point (GB1), the maxillary branch is taken from the Quanliao point (SI18), and the mandibular branch is taken from the Jiache point (ST6).Shenting point (DU24), Baihui point (DU20), Hegu point (LI4), Waiguan point (TE5), Yanglingquan point (GB34), and Taichong point (LR3) on the affected side Operation: The EA apparatus will be applied on the Ashi point and (LI4 - TE5). The treatment will last for 30 minutes and the electrical stimulation will be set as 2/100Hz in frequency.

OTHER

EA+Medication Group

Participants in the EA+Medication group would receive both EA and medical treatement. The acupoints and their location, needles, the settings of the EA device are the same as EA Group's; in the meanwhile, the medication and its dosage is the same as Medication Group's.

Sponsors & Collaborators

  • The Third Affiliated hospital of Zhejiang Chinese Medical University

    collaborator OTHER

  • The Third People's Hospital of Hangzhou

    lead OTHER

Principal Investigators

  • Pin Lin · The Hangzhou Third People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2025-07-20
Completion
2025-12-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261801 on ClinicalTrials.gov