Self-acupuncture for Migraines Feasibility Study

NCT06716944 | Enrolling By Invitation Phase 1

• 1 other identifier: SAM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

migraine; acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Migraine Disability Assessment (MIDAS)

  From enrolment to end of intervention at 24 weeks

• Migraine-Specific Quality of Life Questionnaire (MSQ v2.1)

  From enrolment to end of intervention at 24 weeks

• Pain Catastrophising Scale (PCS)

  From enrolment to end of intervention at 24 weeks

Study Arms (2)

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.

Device: Acupuncture

usual care

NO INTERVENTION

Participants can do all the other things they normally do to manage their migraines apart from having acupuncture elsewhere.

Interventions

Acupuncture DEVICE

self-acupuncture

self-acupuncture plus usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of West London: lead

Study Sites (1)

Royal London Hospital for Integrated Medicine

London, WC1N 3HR, United Kingdom

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief investigator

Model Details: This study is not to test the device (acupunture0 but the trial design

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: December 4, 2024
• Study Start: September 13, 2024
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

GB (1)