A Feasibility Trial of Self-Acupuncture for Patients With Migraines (SAM)
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Headache Impact Test (HIT6)
研究概览
简要总结
Patients who have had a course of acupuncture at the Royal London Hospital for Integrated Medicine to manage their migraines, and found it effective, will be taught to do self-acupuncture. This is a feasibility study so the main aim is to test the trial design but the researchers will also explore self-acupuncture's effectiveness, acceptability and safety.
详细描述
Aim: The proposed study will evaluate the feasibility of teaching SA to patients with migraines in the United Kingdom National Health Service setting.
Methodology: The study will employ a pragmatic, mixed-methods, randomised, parallel-group, exploratory design. The study will compare SA plus standard care versus standard care alone. Participants will complete outcome measures at various time points and be invited to take part in a qualitative telephone interview to explore their views on the design of the study and acceptability of the intervention. The researcher will take field notes of the observation of the SA teaching session to explore the acceptability of the SA teaching method. Data will be analysed to test the hypothesis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years old and over.
- •Patients with migraines (when topiramate and propranolol are unsuitable).
- •Patients who have been referred to the Royal London Hospital for Integrated Medicine (RLHIM) for a course of at least 6 acupuncture sessions to manage their migraines.
- •Patients who have completed a course of acupuncture for the management of their migraines at RLHIM and self-declare that they benefitted from it.
- •Patients must have completed the course of acupuncture within the last 3 to 24 months.
排除标准
- •Patients unwilling to participate (for instance due to needle phobia).
- •Patients currently receiving acupuncture.
- •Patients with severe clotting dysfunction or who bruise spontaneously.
- •Patients unable to complete the questionnaires as judged by the researchers.
- •Patients who have previously been taught or have practiced SA.
- •Patients who are assessed as being unable to do SA (such as if they have poor hand function).
结局指标
主要结局
Headache Impact Test (HIT6)
时间窗: From enrolment to end of intervention at 24 weeks
HIT-6 assesses the burden of headaches (including migraine) by assessing the impact of headaches on peoples' daily living, work and social situations. Patients rate six areas of potential impact on a 5-part scale from 'never' to 'always'.
次要结局
未报告次要终点
研究者
Catrina Davy
Chief investigator
University of West London