The Synergism and Attenuation Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia：Protocol for a Multicentre Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- Changes in Visual Analog Scale (VAS) scores from baseline to the end of the 4th week of treatment
研究概览
简要总结
Trigeminal neuralgia (TN), characterized by its refractory nature and recurrence, frequently leads to anxiety, depression, and insomnia, thereby significantly diminishing patients' quality of life and potentially inducing self-harm. Carbamazepine (CBZ) is the first-line medication for TN, yet it presents adverse effects such as addiction and the absence of analgesic effects upon cessation. Acupuncture, particularly electroacupuncture（EA）, has demonstrated efficacy in TN treatment, although its therapeutic outcomes are influenced by various factors. This multicenter, randomized controlled trial aims to evaluate the synergistic efficacy-enhancing and toxicity-reducing effects of the optimized protocol when combined with carbamazepine (CBZ) in treating trigeminal neuralgia (TN), thereby proposing novel therapeutic refinements for electroacupuncture treatment regimens in TN management.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria to be eligible for this study:
- •Met the diagnostic criteria for trigeminal neuralgia (TN) as defined in the International Classification of Headache Disorders, 3rd edition (ICHD-3) published by the International Headache Society (IHS) in
- •Between 18 and 75 years old (inclusive), regardless of gender;
- •Currently prescribed carbamazepine (400-800 mg/day) or oxcarbazepine (800-1600 mg/day);
- •Conscious, alert, and capable of perceiving/differentiating pain, with basic communication abilities;
- •Signed informed consent form and voluntary participation in the study.
排除标准
- •Patients meeting any of the following criteria were excluded:
- •Patients with epilepsy, head injury, or other relevant neurological disorders;
- •Patients with severe cardiac, hepatic, or renal impairment;
- •Patients with cognitive dysfunction, aphasia, psychiatric disorders, or those unable to cooperate with treatment;
- •Patients with poorly controlled hypertension or hyperglycemia;
- •Patients with a recent diagnosis of severe anxiety or depression;
- •Pregnant or breastfeeding patients;
- •Patients with pacemakers or other contraindications to electroacupuncture;
- •Patients concurrently enrolled in other clinical studies.
研究组 & 干预措施
sham EA +CBZ group
干预措施: CBZ (Drug)
sham EA +CBZ group
干预措施: Sham electroacupuncture (Procedure)
EA+CBZ+placebo group
干预措施: CBZ placebo (Drug)
EA+CBZ+placebo group
干预措施: CBZ (Drug)
EA+CBZ+placebo group
干预措施: Electroacupuncture (Procedure)
结局指标
主要结局
Changes in Visual Analog Scale (VAS) scores from baseline to the end of the 4th week of treatment
时间窗: Baseline, 4 weeks after treatment.
The Visual Analog Scale (VAS) consists of a 10-cm line, where '0' indicates 'no pain' and '10' represents 'unbearable pain,' with increasing pain intensity from 0 to 10. Patients self-assess their pain level by marking the scale, and the investigator records the score."
次要结局
- Changes in Visual Analog Scale (VAS) scores(Baseline, 2 weeks after treatment, at 4-week follow-up.)
- Pain Diary Card(Daily from enrollment through four weeks after treatment completion)
- Carbamazepine Adverse Reactions(Daily from enrollment through four weeks after treatment completion)
- Hepatorenal function(Baseline, 4 weeks after treatment.)
- Changes in the The Self-Rating Anxiety Scale (SAS)(Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.)
- Changes in the Self-Rating Depression Scale (SDS)(Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.)
研究者
Yuanyuan Wu
Associate Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University