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NCT Number: NCT06261801

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • meet the aforementioned diagnostic criteria for trigeminal ZAP, with a disease duration of 1 to 3 months;
  • have a visual analog scale (VAS) score of 4 points ≤ VAS ≤ 7 points;
  • be between 18 and 85 years old, regardless of gender;
  • have clear consciousness, the ability to distinguish pain, and complete basic communication;
  • voluntarily participate in the study, sign a written informed consent form, and fully understand the plan.

Exclusion criteria

  • do not meet the above-mentioned inclusion criteria;
  • have concomitant herpes zoster on the trunk or extremities, or other special types of herpes zoster like meningeal herpes zoster or visceral herpes zoster;
  • are pregnant or lactating patients;
  • are allergic to pregabalin or acupuncture stimulation;
  • have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or other serious diseases that hinder cooperation with treatment;
  • have severe skin diseases;
  • have a pacemaker;
  • have been or are currently participating in other clinical studies within the past 3 months.

Treatment and study plan

Medication group

Other

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.

EA Group

Other

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.

EA+Medication Group

Other

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.

Primary outcomes

  1. Visual Analog Score change

    Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

    Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.

Secondary outcomes

  1. McGill Pain Questionnaire Short Form (SF-MPQ)

    Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

    SF-MPQ focuses on the characteristics, intensity, syndrome and changes of pain during treatment without taking too much time, so it can sensitively reflect clinical changes and reflect the effectiveness of treatment.

  2. Brief Pain Inventory Scale (BPI-SF)

    Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

    BPI-SF includes descriptive words such as the cause of pain, nature of pain, impact on life, and location of pain, which are used to describe the degree of pain and evaluate pain in various aspects.

  3. Medical Outcomes Study Sleep Scale (MOS-SS)

    Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

    The MOS-SS consists of 12 items related to sleep quality over a 4-week recall period.

  4. Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA)

    Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

    HAMA will be used to assess the anxiety status of the participants

  5. Hamilton Depression Rating Scale (HAMD)

    Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

    HAMD will be used to assess the depression status of the participants

  6. Short Form 36 Health Survey (SF-36)

    Time frame: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)

    The SF-36 is a questionnaire with proven reliability and validity and is widely used to assess people's quality of life.

Study contacts

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

Chengcheng Kong

CONTACT

[email protected]

8613868078286

Pin Lin

CONTACT

[email protected]

1358876268686

Sponsors and collaborators

Lead sponsor

The Third People's Hospital of Hangzhou

Other

Collaborators

  • The Third Affiliated hospital of Zhejiang Chinese Medical University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Feb 21, 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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