Migraine
Conditions
Brief 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. 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.
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.
Interventions
Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day.
BEHAVIORALMonitored 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets migraine criteria and has 4+ headache days a month
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Migraine Disability Assessment Scale (MIDAS) Score | Baseline, Month 3 Post-Discharge | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Headache Days Based on MIDAS | Baseline | Information from the Migraine Disability Assessment Scale (MIDAS) questionnaire will be used to calculate the number of headache days at baseline. |
| Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores | Baseline, Month 3 Post-Discharge | 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. |
| Change in MSQv2 - Emotional Function (EF) Domain Scores | Baseline, Month 3 Post-Discharge | 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. |
| Change in MSQv2 - Role Function Preventive (RFP) Domain Scores | Baseline, Month 3 Post-Discharge | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| 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. | 48 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant excluded from analysis as they did not meet criteria of MIDAS score > 5 | 8 | 6 |
| Overall Study | Technology issues prevented participant from receiving intervention | 2 | 2 |
Baseline characteristics
| Characteristic | Progressive Muscle Relaxation (PMR) Therapy | Total | Monitored Usual Care (MUC) |
|---|---|---|---|
| Age, Continuous | 31 years | 33.5 years | 36 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 26 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 66 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 22 Participants | 10 Participants |
| Race (NIH/OMB) White | 23 Participants | 50 Participants | 27 Participants |
| Region of Enrollment United States | 46 participants | 94 participants | 48 participants |
| Sex/Gender, Customized Female | 36 Participants | 75 Participants | 39 Participants |
| Sex/Gender, Customized Male | 9 Participants | 17 Participants | 8 Participants |
| Sex/Gender, Customized Other Gender | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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: * 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)
Time frame: Baseline, Month 3 Post-Discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progressive Muscle Relaxation (PMR) Therapy | Change in Migraine Disability Assessment Scale (MIDAS) Score | -25.1 score on a scale | Standard Deviation 29.6 |
| Monitored Usual Care (MUC) | Change in Migraine Disability Assessment Scale (MIDAS) Score | 6.9 score on a scale | Standard Deviation 59.6 |
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.
Time frame: Baseline, Month 3 Post-Discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progressive Muscle Relaxation (PMR) Therapy | 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 |
| Monitored Usual Care (MUC) | Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores | 18.7 score on a scale | Standard Deviation 26.8 |
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.
Time frame: Baseline, Month 3 Post-Discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progressive Muscle Relaxation (PMR) Therapy | Change in MSQv2 - Emotional Function (EF) Domain Scores | 26.5 score on a scale | Standard Deviation 26.5 |
| Monitored Usual Care (MUC) | Change in MSQv2 - Emotional Function (EF) Domain Scores | 19.8 score on a scale | Standard Deviation 38.5 |
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.
Time frame: Baseline, Month 3 Post-Discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Progressive Muscle Relaxation (PMR) Therapy | Change in MSQv2 - Role Function Preventive (RFP) Domain Scores | 16.9 score on a scale | Standard Deviation 16.9 |
| Monitored Usual Care (MUC) | Change in MSQv2 - Role Function Preventive (RFP) Domain Scores | 11.3 score on a scale | Standard Deviation 25.9 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Progressive Muscle Relaxation (PMR) Therapy | Number of Headache Days Based on MIDAS | 14 Headache Days |
| Monitored Usual Care (MUC) | Number of Headache Days Based on MIDAS | 10 Headache Days |