Trial Outcomes & Findings for Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department (NCT NCT04281030)
NCT ID: NCT04281030
Last Updated: 2025-07-24
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Baseline, Month 3 Post-Discharge
Results posted on
2025-07-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
Participants Allocated to Intervention
|
54
|
54
|
|
Overall Study
COMPLETED
|
46
|
48
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Technology issues prevented participant from receiving intervention
|
2
|
2
|
|
Overall Study
Participant excluded from analysis as they did not meet criteria of MIDAS score > 5
|
8
|
6
|
Baseline Characteristics
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
Baseline characteristics by cohort
| Measure |
Progressive Muscle Relaxation (PMR) Therapy
n=46 Participants
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.
|
Monitored Usual Care (MUC)
n=48 Participants
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.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
n=5 Participants
|
36 years
n=7 Participants
|
33.5 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other Gender
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
48 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3 Post-Discharge5-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)
Outcome measures
| Measure |
Progressive Muscle Relaxation (PMR) Therapy
n=34 Participants
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.
|
Monitored Usual Care (MUC)
n=35 Participants
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.
|
|---|---|---|
|
Change in Migraine Disability Assessment Scale (MIDAS) Score
|
-25.1 score on a scale
Standard Deviation 29.6
|
6.9 score on a scale
Standard Deviation 59.6
|
SECONDARY outcome
Timeframe: BaselineInformation from the Migraine Disability Assessment Scale (MIDAS) questionnaire will be used to calculate the number of headache days at baseline.
Outcome measures
| Measure |
Progressive Muscle Relaxation (PMR) Therapy
n=46 Participants
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.
|
Monitored Usual Care (MUC)
n=48 Participants
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.
|
|---|---|---|
|
Number of Headache Days Based on MIDAS
|
14 Headache Days
Interval 6.0 to 20.0
|
10 Headache Days
Interval 5.0 to 16.0
|
SECONDARY outcome
Timeframe: Baseline, Month 3 Post-DischargeThe 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.
Outcome measures
| Measure |
Progressive Muscle Relaxation (PMR) Therapy
n=34 Participants
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.
|
Monitored Usual Care (MUC)
n=35 Participants
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.
|
|---|---|---|
|
Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores
|
18.1 score on a scale
Standard Deviation 18.1
|
18.7 score on a scale
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: Baseline, Month 3 Post-DischargeThe 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.
Outcome measures
| Measure |
Progressive Muscle Relaxation (PMR) Therapy
n=34 Participants
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.
|
Monitored Usual Care (MUC)
n=35 Participants
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.
|
|---|---|---|
|
Change in MSQv2 - Emotional Function (EF) Domain Scores
|
26.5 score on a scale
Standard Deviation 26.5
|
19.8 score on a scale
Standard Deviation 38.5
|
SECONDARY outcome
Timeframe: Baseline, Month 3 Post-DischargeThe 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.
Outcome measures
| Measure |
Progressive Muscle Relaxation (PMR) Therapy
n=34 Participants
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.
|
Monitored Usual Care (MUC)
n=35 Participants
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.
|
|---|---|---|
|
Change in MSQv2 - Role Function Preventive (RFP) Domain Scores
|
16.9 score on a scale
Standard Deviation 16.9
|
11.3 score on a scale
Standard Deviation 25.9
|
Adverse Events
Progressive Muscle Relaxation (PMR) Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Monitored Usual Care (MUC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place