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

NCT04281030 | Completed Results DMC

• 2 other identifiers: 16-00548 - 21K23AT009706-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (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)

  Baseline, Month 3 Post-Discharge

Secondary Outcomes (4)

• Number of Headache Days Based on MIDAS

  Baseline

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

  Baseline, Month 3 Post-Discharge

• Change in MSQv2 - Emotional Function (EF) Domain Scores

  Baseline, Month 3 Post-Discharge

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

  Baseline, Month 3 Post-Discharge

Study Arms (2)

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.

Behavioral: PMR (Progressive muscle relaxation therapy)

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.

Behavioral: Monitored Usual Care (MUC)

Interventions

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.

Progressive Muscle Relaxation (PMR) Therapy

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.

Monitored Usual Care (MUC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

NYU Langone

New York, New York, 10003, United States

Location

Related Publications (1)

• 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.

  PMID: 41100087 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Mia Minen
• Organization: NYU Langone Health

Mia.Minen@nyulangone.org

9294555130

Study Officials

• Mia Minen, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: February 21, 2020
• Study Start: June 30, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 24, 2025
• Results First Posted: February 7, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)