Clinical trial NCT06716944: Self-acupuncture for Migraines Feasibility Study
Official title: A Feasibility Trial of Self-Acupuncture for Patients With Migraines (SAM)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Migraine
Keywords: migraine
acupuncture
Lead sponsor: University of West London
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is not to test the device (acupunture0 but the trial design
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Headache Impact Test (HIT6)
timeFrame: From enrolment to end of intervention at 24 weeks
Secondary outcomes:
Other outcomes:
measure: Migraine Disability Assessment (MIDAS)
timeFrame: From enrolment to end of intervention at 24 weeks
measure: Migraine-Specific Quality of Life Questionnaire (MSQ v2.1)
timeFrame: From enrolment to end of intervention at 24 weeks
measure: Pain Catastrophising Scale (PCS)
timeFrame: From enrolment to end of intervention at 24 weeks
measure: Migraine diary
timeFrame: From enrolment to end of intervention at 24 weeks
Locations:
city: London
country: United Kingdom
facility: Royal London Hospital for Integrated Medicine
Study officials:
References: