N/A
Completed N=112
Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
Source: ClinicalTrials.gov NCT04281030 ↗Enrolled (actual)
112
Serious AEs
—
Results posted
Feb 2024
Primary outcomePrimary: Change in Migraine Disability Assessment Scale (MIDAS) Score — -25.1; 6.9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Migraine Disability Assessment Scale (MIDAS) Score |
-25.1; 6.9 | — |
| SECONDARY Number of Headache Days Based on MIDAS |
14; 10 | — |
| SECONDARY Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores |
18.1; 18.7 | — |
| SECONDARY Change in MSQv2 - Emotional Function (EF) Domain Scores |
26.5; 19.8 | — |
| SECONDARY Change in MSQv2 - Role Function Preventive (RFP) Domain Scores |
16.9; 11.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04281030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.