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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AT009706-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive Muscle Relaxation (PMR) Therapy | Experimental | After 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. |
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| Monitored Usual Care (MUC) | Active Comparator | Subjects 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMR (Progressive muscle relaxation therapy) | Behavioral | Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Baseline, Month 3 Post-Discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mia Minen, MD | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone | New York | New York | 10003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41100087 | Derived | 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. |
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Will be provided upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | Progressive Muscle Relaxation (PMR) Therapy | After the Progressive Muscle Relaxation (PMR) APP is loaded onto the subject's smartphone, the subject will perform PMR in the emergency department (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. PMR (Progressive muscle relaxation therapy): Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day. |
| FG001 | Monitored Usual Care (MUC) | Subjects 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. Monitored Usual Care (MUC): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Progressive Muscle Relaxation (PMR) Therapy | After 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. PMR (Progressive muscle relaxation therapy): Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3 Post-Discharge |
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Adverse events, serious adverse events, and all-cause mortality were not assessed among participants in this study, as minimal to no risk was expected for participants in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Progressive Muscle Relaxation (PMR) Therapy | After 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. PMR (Progressive muscle relaxation therapy): Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mia Minen | NYU Langone Health | 9294555130 | Mia.Minen@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2020 | Jun 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Monitored Usual Care (MUC) | Behavioral | 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. |
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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. |
| Baseline, Month 3 Post-Discharge |
| 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. | Baseline, Month 3 Post-Discharge |
| 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. | Baseline, Month 3 Post-Discharge |
| BG001 | Monitored Usual Care (MUC) | Subjects 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 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. Monitored Usual Care (MUC): 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Monitored Usual Care (MUC) | Subjects 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 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. Monitored Usual Care (MUC): 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. |
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| Secondary | 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. | Posted | Mean | Inter-Quartile Range | Headache Days | Baseline |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3 Post-Discharge |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3 Post-Discharge |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3 Post-Discharge |
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| 0 |
| 0 |
| 0 |
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| EG001 | Monitored Usual Care (MUC) | Subjects will be given general educational information consisting of basic migraine information such as evidence-based ways to treat migraines: 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 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. Monitored Usual Care (MUC): 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |