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Self-acupuncture for Migraines Feasibility Study

NCT ID: NCT06716944

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine

Keywords

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migraine acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is not to test the device (acupunture0 but the trial design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

self-acupuncture

usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

self-acupuncture

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of West London

OTHER

Sponsor Role lead

Responsible Party

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Catrina Davy

Chief investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Royal London Hospital for Integrated Medicine

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SAM

Identifier Type: -

Identifier Source: org_study_id