Self-acupuncture for Migraines Feasibility Study (SAM)

A Feasibility Trial of Self-Acupuncture for Patients With Migraines (SAM)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Migraine
• Intervention / Treatment: Device: Acupuncture

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3HR
    • Royal London Hospital for Integrated Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: self-acupuncture plus usual care; 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.	Device: Acupuncture; self-acupuncture
No Intervention: usual care; Participants can do all the other things they normally do to manage their migraines apart from having acupuncture elsewhere.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of West London

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: acupuncture; migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: SAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I'm not sure what it involves

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No