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MigraineNCT04281030

Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

A study testing PMR (Progressive muscle relaxation therapy) in people with Migraine, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot feasibility acceptability study to examine the impact of smartphone-based progressive muscle relaxation (PMR) on migraine quality of life, frequency, intensity, and disability. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
PMR (Progressive muscle relaxation therapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteUnited States
Study dates
30 Jun 2019to 30 Mar 2022
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets migraine criteria and has 4+ headache days a month

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
  • Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
  • Not having a smartphone

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NYU Langone

    New York, New York, 10003

Other trials in United States

About this study

This is a pilot feasibility acceptability study to examine the impact of smartphone-based progressive muscle relaxation (PMR) on migraine quality of life, frequency, intensity, and disability. Feasibility is measured by: a) Proportion of patients who enrolled in the study/were recruited for the study, b) Number of days PMR practiced/week as determined with the backend analytics in the RELAXaHEAD app, c) Minutes/day spent doing PMR, d) Reasons for non-adherence. Acceptability is measured by: a) Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality b) Willingness to repeat a similar treatment intervention in the future (Definitely No/Probably No/Unsure/Probably Yes/ Definitely Yes) c) Attrition. In addition, whether use of electronically based PMR introduced in the emergency department (ED) improves migraine quality of life (MSQv2) and migraine related disability (MIDAS) at 3 months post ED-discharge (or post enrollment date if recruited post ED discharge) compared to those who are not introduced to PMR will be assessed. All participants will be asked to track their headache frequency and intensity using our smartphone application (app) and will be asked to complete migraine quality of life assessments and migraine related disability at follow-up.

Read the detailed description

While explaining the study, potential participants will be assured that they will receive all of the medication for their acute headache that they would otherwise receive. Once consented, participants will be randomized to PMR therapy or monitored usual care (MUC). Participants will be told that either group is being tested as an enhancement to the care they typically get in the ED for headache. (At the end, they will be informed which group they were in.) The study team will collect participants' health histories (biologic variables) and baseline data in REDCap, download the app onto subjects' smartphones, and conduct the sessions.

Conditions
Migraine
Being tested
PMR (Progressive muscle relaxation therapy), Monitored Usual Care (MUC)
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PMR (Progressive muscle relaxation therapy)Behavioural

    Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day.

  • Monitored Usual Care (MUC)Behavioural

    Subjects will be given basic migraine information such as evidence-based ways to treat migraine: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.

Study groups in NCT04281030
Study groupRoleWhat they receive
Progressive Muscle Relaxation (PMR) TherapyExperimentalAfter the PMR APP is loaded onto the subject's smartphone, the subject will perform PMR in the ED and discuss the optimal time and place to practice PMR at home. All subjects will be asked to keep records of headache occurrence, side effects, compliance, and medication changes on the APP.
Receives: Behavioral: PMR (Progressive muscle relaxation therapy)
Monitored Usual Care (MUC)Active comparatorSubjects will be given general educational information consisting of basic migraine information such as evidence-based ways to treat migraine: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently. Any migraine treatment decisions on discharge will be left up to the ED attending. The research coordinator (RC) will load the APP onto the subjects' smart phones but the PMR component will be blocked on the version of the APP that the MUC subjects receive. All subjects will be asked to keep records of headache occurrence, side effects, compliance, and medication changes on the APP.
Receives: Behavioral: Monitored Usual Care (MUC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Migraine Disability Assessment Scale (MIDAS) Score

    5-item self-administered questionnaire designed to quantify headache-related disability over a 3-month period. For each item, participants indicate the number of days over the past three months that migraine limited their ability to participant in specific activities.

    The score is the sum responses. Scores are classified as follows:

    • 0 to 5 = Little or no disability (MIDAS Grade I)
    • 6 to 10 = Mild disability (MIDAS Grade II)
    • 11 to 20 = Moderate disability (MIDAS Grade III)
    • 21-40 = Severe disability (MIDAS Grade IV-A)
    • Greater than 40 = Very severe disability (MIDAS Grade IV-B)

    Measured: Baseline, Month 3 Post-Discharge

Secondary outcomes (4)

  1. Number of Headache Days Based on MIDAS

    Information from the Migraine Disability Assessment Scale (MIDAS) questionnaire will be used to calculate the number of headache days at baseline.

    Measured: Baseline

  2. Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores

    The MSQv2 is a 14-item self-assessment of how migraines affect a patient's life. 7 of the items assess the Role Function-Restrictive (RFR) Domain, which measures the functional impact of migraine through limitations on daily social and work activities.

    Items are ranked on 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of time; 5 = Most of the time; and 6 = All of the time.

    The raw dimension score is computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.

    Measured: Baseline, Month 3 Post-Discharge

  3. Change in MSQv2 - Emotional Function (EF) Domain Scores

    The MSQv2 is a 14-item self-assessment of how migraines affect a patient's life. 3 of the items assess the Emotional Function (EF) Domain, which measures the emotional impact of migraine.

    Items are ranked on 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of time; 5 = Most of the time; and 6 = All of the time.

    The raw dimension score is computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.

    Measured: Baseline, Month 3 Post-Discharge

  4. Change in MSQv2 - Role Function Preventive (RFP) Domain Scores

    The MSQv2 is a 14-item self-assessment of how migraines affect a patient's life. 4 of the items assess the Role Function-Preventive (RFP) Domain, which measures the impact of migraine through prevention of daily work and social activities

    Items are ranked on 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of time; 5 = Most of the time; and 6 = All of the time.

    The raw dimension score is computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life.

    Measured: Baseline, Month 3 Post-Discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2020
  2. Study start30 Jun 2019
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281030
Sponsor's protocol ID
16-00548 - 2
Other IDs
1K23AT009706-01
Status last verified
Jul 2025
First submitted
26 Dec 2019
Last updated
24 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will be provided upon request

Publications

  • Minen MT, Seng EK, Friedman BW, George AD, Fanning KM, Bostic RC, Powers SW, Lipton RB. Smartphone-Based Muscle Relaxation for Migraine in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2534221. doi: 10.1001/jamanetworkopen.2025.34221.

    PubMed 41100087

Questions about this trial

What is this clinical trial studying?

A study testing PMR (Progressive muscle relaxation therapy) in people with Migraine, 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 1 inclusion and 5 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 24 Jul 2025. 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 7 Feb 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?

Change in Migraine Disability Assessment Scale (MIDAS) Score (time frame: Baseline, Month 3 Post-Discharge). 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 NCT04281030, 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 24 Jul 2025.

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