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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| self-acupuncture plus usual care | Active Comparator | Participants will be taught to do self-acupuncture to manage their migraines. They can also do all the other things they normally do to manage their migraines apart from having acupuncture elsewhere. |
|
| usual care | No Intervention | Participants can do all the other things they normally do to manage their migraines apart from having acupuncture elsewhere. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | self-acupuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache Impact Test (HIT6) | 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'. | From enrolment to end of intervention at 24 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Migraine Disability Assessment (MIDAS) | 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). | From enrolment to end of intervention at 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal London Hospital for Integrated Medicine | London | WC1N 3HR | United Kingdom |
I'm not sure what it involves
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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This study is not to test the device (acupunture0 but the trial design
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| Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) | 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'. | From enrolment to end of intervention at 24 weeks |
| Pain Catastrophising Scale (PCS) | 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'. | From enrolment to end of intervention at 24 weeks |
| Migraine diary | 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. | From enrolment to end of intervention at 24 weeks |
| D009422 | Nervous System Diseases |