Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Visual Analog Score change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Medication Group
Participants in the medication group would take 150-mg pregabalin capsules orally twice daily (total daily dose, 300 mg) for 4 weeks. The follow-up period is 3 months.
干预措施: Medication Group (Other)
EA Group
The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The follow-up period is 3 months.
干预措施: EA Group (Other)
EA+Medication Group
The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including electroacupuncture(EA) treatment and combined with pregabalin (0.15g each time, twice daily). The follow-up period is 3 months.
干预措施: EA+Medication Group (Other)
结局指标
主要结局
Visual Analog Score change
时间窗: 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.
次要结局
- Hamilton Depression Rating Scale (HAMD)Hamilton Anxiety Rating Scale (HAMA)(Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up))
- McGill Pain Questionnaire Short Form (SF-MPQ)(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)(Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up))
- Hamilton Depression Rating Scale (HAMD)(Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up))
- Brief Pain Inventory Scale (BPI-SF)(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)(Weeks 0 (baseline), Week 2 (Treatment), Week 4 (Treatment), Week 8 (Follow-up), and Week 16 (Follow-up))
研究者
Ling Pin
Chief physician
The Third People's Hospital of Hangzhou