MigrainePhase 1/2SAMNCT06716944
Self-acupuncture for Migraines Feasibility Study
A Phase 1/2 study testing Acupuncture in people with Migraine, run by University of West London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Sep 2024to Mar 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Royal London Hospital for Integrated Medicine
London, WC1N 3HR
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Acupuncture
- Keywords
- migraine, acupuncture
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
self-acupuncture
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: From enrolment to end of intervention at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start13 Sep 2024
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is not to test the device (acupunture0 but the trial design
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catrina Davy, University of West London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716944
- Sponsor's protocol ID
- SAM
- Acronym
- SAM
- Status last verified
- Nov 2024
- First submitted
- 29 Oct 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I'm not sure what it involves
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of Self-Acupuncture for Patients With Migraines (SAM)
- ClinicalTrials.gov ID
- NCT06716944
- Acronym / sponsor ID
- SAM / SAM
- Conditions
- Migraine
- Keywords
- migraine, acupuncture
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of West LondonUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is not to test the device (acupunture0 but the trial design
| Arm | Type | Receives |
|---|---|---|
| self-acupuncture plus usual care | Active comparator | Device: AcupunctureParticipants 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. |
| usual care | No intervention | –Participants can do all the other things they normally do to manage their migraines apart from having acupuncture elsewhere. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupunctureself-acupuncture | Device | self-acupuncture plus usual care |
Primary outcome
Headache Impact Test (HIT6)
Time frame: 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'.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided. I'm not sure what it involves
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acupuncture in people with Migraine, run by University of West London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Test (HIT6) (time frame: From enrolment to end of intervention at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.