JAMA Netw Open. 2025 Oct 1;8(10):e2534221. doi: 10.1001/jamanetworkopen.2025.34221.
ABSTRACT
IMPORTANCE: The emergency department (ED) is a critical point of contact within the health care system and an opportunity to initiate nonpharmacologic migraine treatment.
OBJECTIVE: To examine whether progressive muscle relaxation (PMR) smartphone-based migraine self-management improved patient-reported outcomes for migraine compared with enhanced usual care.
DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial of the smartphone application RELAXaHEAD with and without PMR. Patients aged 18 to 65 years visiting New York University Langone Health EDs for headache who met migraine criteria and self reported 4 or more migraine days per month were recruited from June 2019 to October 2021 with follow-up at 3 months. Data were analyzed from June 2022 to June 2025.
INTERVENTION: Participants in the intervention group were asked to listen to the app-based PMR for 60 days. Participants in the control group were asked to use the app as a symptom diary.
MAIN OUTCOMES AND MEASURES: Primary outcome was change in migraine-related disability (MIDAS). Secondary outcomes were change in migraine-specific quality of life (MSQv2) and monthly headache days (MHDs). Adherence (number of days of diary use, PMR use and total minutes of PMR use over 90-day period) was measured using back-end analytics.
RESULTS: Of the 94 patients (median [IQR] age, 33 [26-45] years; 57 [82.6%] female) randomized (48 control patients and 46 PMR patients), 69 of 94 (73%) had 1 or more follow-up MIDAS scores and constituted the modified intent-to-treat population (35 control patients and 34 PMR patients). The mean (SD) change in MIDAS scores from baseline to 3 months (last observation carried forward [LOCF] used if missing 3-month follow-up data) differed between groups (PMR, 25.09 [29.64] vs control, 6.86 [59.61]; P = .01). PMR had nearly double the number of respondents improving by 5 or more MIDAS points (28 of 34 [82.4%] vs 16 of 35 [45.7%] respondents; P = .002). There was no difference in MSQv2 domains from baseline to LOCF between PMR and control (mean [SD] role function preventive domain for PMR, 16.9 [24.5] vs control, 11.3 [25.9]); emotional function domain (mean [SD] for PMR, 26.5 [26.9] vs control, 19.8 [38.5]); and role function restrictive domain (mean [SD] for PMR, 18.1 [22.7] vs control, 18.7 [26.8]). Mean (SD) change in MHDs (baseline to 3 months) did not differ between groups (PMR, 2.9 [8.0]; 23 days vs control, -1.6 [6.5]; 25 days).
CONCLUSION AND RELEVANCE: A PMR-based self-management program offered to patients with migraine after ED discharge yielded clinically significant reductions in migraine-related disability.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04281030.
PMID:41100087 | DOI:10.1001/jamanetworkopen.2025.34221
