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

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

Recruiting
18-85 years
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study details
    Trigeminal Herpetic Neuralgia

NCT06261801

The Third People's Hospital of Hangzhou

21 February 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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