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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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)
• Другое 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.

Первичные конечные точки

• Visual Analog Score change [Срок оценки: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)]

Вторичные конечные точки (6)

• McGill Pain Questionnaire Short Form (SF-MPQ) [Срок оценки: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)]
• Brief Pain Inventory Scale (BPI-SF) [Срок оценки: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)]
• Medical Outcomes Study Sleep Scale (MOS-SS) [Срок оценки: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)]
• Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)]
• Hamilton Depression Rating Scale (HAMD) [Срок оценки: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)]
• Short Form 36 Health Survey (SF-36) [Срок оценки: Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Hangzhou Third People's Hospital — Ханчжоу

Публикации

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Идентификаторы

NCT: NCT06261801 · GZY-ZJ-KJ-23088

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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