Self-acupuncture for Migraines Feasibility Study

Phase 1

• Conditions: Migraine

• Registration Number: NCT06716944
• Lead Sponsor: University of West London

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.

Study Timeline

• Study Start: 2024-09-13
• Study First Submitted: 2024-10-29
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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'.

Trial Locations

Locations (1)

Royal London Hospital for Integrated Medicine; 🇬🇧 London, United Kingdom