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

NCT ID: NCT04281030

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2022-03-30

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PMR (Progressive muscle relaxation therapy)

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Monitored Usual Care (MUC)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mia Minen, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

NYU Langone

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 41100087 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K23AT009706-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-00548 - 2

Identifier Type: -

Identifier Source: org_study_id