Migraine
Conditions
Keywords
migraine, acupuncture
Brief summary
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
DEVICEAcupuncture
self-acupuncture
Sponsors
University of West London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is not to test the device (acupunture0 but the trial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Impact Test (HIT6) | 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'. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Migraine Disability Assessment (MIDAS) | From enrolment to end of intervention at 24 weeks | MIDAS assesses the impact headaches or migraines have on peoples' daily living. Patients record the number of days in the last three months that their migraine has impacted their work, household work and social activities (there are five items in the measure). |
| Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) | From enrolment to end of intervention at 24 weeks | MSQ v2.1 assesses the impact of migraine on peoples' quality of life. Patients rate how often in the last four weeks their migraine has impacted various areas of daily living. The questionnaire consists of 14 questions which relate to three areas: daily activities the patient was restricted from doing, daily activities the patient was prevented from doing and impact on emotional wellbeing. Patients can rate the impact of each item on a 6-part scale from 'none of the time' to 'all of the time'. |
| Pain Catastrophising Scale (PCS) | From enrolment to end of intervention at 24 weeks | The PCS measures the impact of pain on peoples' daily living. The questionnaire consists of 13 items. Patients rate the impact pain has on these items on a 5-part scale from 'not at all' to 'all of the time'. |
| Migraine diary | From enrolment to end of intervention at 24 weeks | Participants will be asked to keep a diary of their migraines. They will be asked to record the frequency, duration and severity of their migraines, other symptoms they experienced (such as dizziness or nausea), any migraine or pain medication they took and any other comments. |
Countries
United Kingdom
Outcome results
None listed