MigraineNCT05466682
RELAXaHEAD for Headache Patients (Phase II)
A study testing Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) in people with Migraine and Headache, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine, Headache, Multiple Sclerosis
- What is being tested?
- Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2022to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years (age 18-65 in urgent care);
- Meets migraine criteria based on the International Classification of Headache Disorders (ICHD) criteria;
- Migraine Disability Assessment (MIDAS) score >5. 4+ headache days a month OR; meets chronic post- traumatic headache (PTH) criteria based on International Classification of Headache Disorders (ICHD) criteria, is 3-12 months post-injury, and there are 4+ headache days a month.
- Scoring > or = 15 on the ISI.
Who cannot join
- Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other Relaxation Therapy in the past year;
- Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy;
- Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;
- Opioid or barbiturate use 10+ days a month;
- Unable or unwilling to follow a treatment program that relies on written and audio file materials;
- Not having a smartphone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RELAXaHEAD for Headache Patients (Phase II): RELAXaHEAD for Migraine and Sleep
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. The app has been studied and findings have been reported in multiple peer reviewed publications. Also, the app has been updated based on prior feedback from the studies. Now, this 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine and comorbid insomnia. . One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with migraine and insomnia (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache and sleep related outcome measures (Aim 2).
- Conditions
- Migraine, Headache, Multiple Sclerosis, Insomnia
- Being tested
- Smartphone-Based Progressive Muscle Relaxation Therapy (PMR), Monitored Usual Care (MUC)
- Keywords
- Progressive Muscle Relaxation Therapy, Migraine, Insomnia
- Medical subject headings
- Migraine Disorders, Headache, Multiple Sclerosis, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)Behavioural
Relaxation technique delivered via RELAXaHEAD app.
Monitored Usual Care (MUC)Behavioural
Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.
| Study group | Role | What they receive |
|---|---|---|
| RELAX | Experimental | Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app.
Patients will be asked to do the following:
* Week 1: 5 min deep breathing at least 5/7 days of the week
* Week 2: 5 min PMR session at least 5/7 days of the week
* Week 3: 15 min PMR session at least 5/7 days of the week
* Week 4: PMR at least 4 days a week
* Week 5: PMR at least 3 days a week
* Weeks 6-8: Use PMR when it is most helpful
Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine. Receives: Behavioral: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) |
| Monitored Usual Care (MUC) | Active comparator | Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked.
Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine. Receives: Behavioral: Monitored Usual Care (MUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Enrolled in the Study
Measure of feasibility.
Measured: Baseline
Daily Diary Satisfaction Scores
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Measured: Baseline
Daily Diary Satisfaction Scores
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Measured: Week 1
Daily Diary Satisfaction Scores
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Measured: Month 1
Daily Diary Satisfaction Scores
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Measured: Month 2
Daily Diary Satisfaction Scores
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Measured: Month 3
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Measured: Baseline
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Measured: Week 1
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Measured: Month 1
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Measured: Month 2
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree.
The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Measured: Month 3
Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day
Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
Measured: Up to Month 3
Number of Days Participants Used Diary
Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
Measured: Up to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start9 Jun 2022
- Primary completion19 Dec 2022
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Advancing Point of Care Technologies, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mia Minen, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466682
- Sponsor's protocol ID
- 17-00525-2
- Status last verified
- Jan 2024
- First submitted
- 18 Jul 2022
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Dr. Minen (PI). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Minen MT, George A, Bostic R, Fanning K, Bubu OM. The association between insomnia and migraine disability and quality of life: a secondary analysis of a randomized controlled trial. Pain Med. 2026 Apr 1;27(4):426-433. doi: 10.1093/pm/pnaf149.
PubMed 41206664
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELAXaHEAD for Headache Patients (Phase II): RELAXaHEAD for Migraine and Sleep
- ClinicalTrials.gov ID
- NCT05466682
- Acronym / sponsor ID
- 17-00525-2
- Conditions
- Migraine, Headache, Multiple Sclerosis, Insomnia
- Keywords
- Progressive Muscle Relaxation Therapy, Migraine, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Center for Advancing Point of Care Technologies, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Posted 10 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. The app has been studied and findings have been reported in multiple peer reviewed publications. Also, the app has been updated based on prior feedback from the studies. Now, this 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine and comorbid insomnia. . One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with migraine and insomnia (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache and sleep related outcome measures (Aim 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RELAX | Experimental | Behavioral: Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following: * Week 1: 5 min deep breathing at least 5/7 days of the week * Week 2: 5 min PMR session at least 5/7 days of the week * Week 3: 15 min PMR session at least 5/7 days of the week * Week 4: PMR at least 4 days a week * Week 5: PMR at least 3 days a week * Weeks 6-8: Use PMR when it is most helpful Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine. |
| Monitored Usual Care (MUC) | Active comparator | Behavioral: Monitored Usual Care (MUC)Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years (age 18-65 in urgent care);
- Meets migraine criteria based on the International Classification of Headache Disorders (ICHD) criteria;
- Migraine Disability Assessment (MIDAS) score >5. 4+ headache days a month OR; meets chronic post- traumatic headache (PTH) criteria based on International Classification of Headache Disorders (ICHD) criteria, is 3-12 months post-injury, and there are 4+ headache days a month.
- Scoring > or = 15 on the ISI.
Key exclusion criteria (6 listed)
- Patients who have had Cognitive Behavioral Therapy, Biofeedback, or other Relaxation Therapy in the past year;
- Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy;
- Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;
- Opioid or barbiturate use 10+ days a month;
- Unable or unwilling to follow a treatment program that relies on written and audio file materials;
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 |
|---|---|---|
| Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)Relaxation technique delivered via RELAXaHEAD app. | Behavioural | RELAX |
| Monitored Usual Care (MUC)Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary. | Behavioural | Monitored Usual Care (MUC) |
Primary outcome
Number of Patients Enrolled in the Study
Time frame: Baseline
Measure of feasibility.
Daily Diary Satisfaction Scores
Time frame: Baseline
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Daily Diary Satisfaction Scores
Time frame: Week 1
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Daily Diary Satisfaction Scores
Time frame: Month 1
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Daily Diary Satisfaction Scores
Time frame: Month 2
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Daily Diary Satisfaction Scores
Time frame: Month 3
5-item self-assessment measuring satisfaction with the daily dairy function of the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-20; higher scores indicate higher levels of satisfaction.
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Time frame: Baseline
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Time frame: Week 1
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Time frame: Month 1
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Time frame: Month 2
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Progressive Muscle Relaxation Therapy (PMR) Satisfaction Scores Among RELAX Arm Participants
Time frame: Month 3
4-item self-assessment measuring satisfaction with PMR administered via the RELAXaHEAD app. Items are ranked on a 5-point Likert scale, where: 0 = Strongly Disagree; 1 = Disagree; 2 = Neither Agree nor Disagree; 3 = Agree; and 4 = Strongly Agree. The total score is the sum of responses. Scores range from 0-16; higher scores indicate higher levels of satisfaction
Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day
Time frame: Up to Month 3
Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
Number of Days Participants Used Diary
Time frame: Up to Month 3
Calculated using the backend analytics in the RELAXaHEAD app. Measure of feasibility.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41206664Minen MT, George A, Bostic R, Fanning K, Bubu OM. The association between insomnia and migraine disability and quality of life: a secondary analysis of a randomized controlled trial. Pain Med. 2026 Apr 1;27(4):426-433. doi: 10.1093/pm/pnaf149.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Dr. Minen (PI). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Mia Minen, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) in people with Migraine and Headache, run by NYU Langone Health at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 10 Jan 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 States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Enrolled in the Study (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05466682, which also lists 1 linked publication.
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 10 Jan 2024.