Self-acupuncture for Migraines Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Feasibility Trial of Self-Acupuncture for Patients With Migraines (SAM)
Overview
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.
Detailed description
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.
Interventions
- Device Acupuncture
self-acupuncture
Primary outcome measures
- Headache Impact Test (HIT6) [Time frame: From enrolment to end of intervention at 24 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Royal London Hospital for Integrated Medicine — London
Identifiers
NCT: NCT06716944 · SAM