Randomized Controlled Trial of a Smartphone-based Preventive Migraine Self-management Program in the Emergency Department Setting: A Promising Teachable Moment
Mia Minen1, Elizabeth Seng3, Benjamin Friedman4, Alexis George2, Kristina Fanning6, Ryan Bostic6, Scott Powers7, Richard Lipton5
1Neurology and Population Health, 2Neurology, NYU Langone Health, 3Psychology, Ferkauf Graduate School of Psychology, Yeshiva University, 4Emergency Medicine, 5Neurology, Psychiatry and Behavioral Sciences, and Epidemiology, Albert Einstein College of Medicine, 6MIST Research and Statistical Consulting, 7Pediatrics, Cincinnati Children's Hospital
Objective:
We examined whether a smartphone self-management progressive muscle relaxation (PMR) based therapy improved patient-centered outcomes for migraine compared to enhanced usual care (EUC).
Background:
The emergency department (ED) is a critical point of contact with the healthcare system for many patients with migraine and an opportunity to initiate accessible nonpharmacologic migraine treatment.
Design/Methods:
We conducted a randomized controlled trial of the smartphone application RELAXaHEAD with and without PMR in patients who visited the ED for headache and met migraine criteria. We collected follow-up data on our primary outcomes (migraine-related disability (MIDAS), migraine-related quality of life (MSQv2), and monthly headache days (MHDs)).
Results:
Of the 94 patients (Control (n=48); PMR (n=46)), 69/94 (73%) had baseline MIDAS and >1 follow-up MIDAS score. MIDAS mean change scores differed for the two groups (Control =6.86 and PMR -25.09, p=0.007). There was a statistically significant difference in the number of respondents improving by >5 MIDAS points for PMR vs. Control (PMR 28/34 (82.4%), Control 16/35 (45.7%), p=0.002) and in the number of respondents improving by ≥10 MIDAS points, with (PMR 21/34 (61.8%), Control 13/35 (37.1%), p=0.041). This effect persisted in Logistic Regression Models, including baseline MIDAS scores. The MSQv2, Role function preventive, and Emotional function change scores were higher among PMR (n=34) than Control (n=35) with PMR 16.9 vs. Control 11.3 and PMR 26.5 vs. Control 19.8, respectively. In the 51% (48/94) of participants with three-month follow-up MHD data, PMR (n=23) had a -2.9±8.0 mean MHD change, and control (n=25), a mean MHD change of -1.6±6.5, p=0.533.
Conclusions:
A PMR-based self-management program yielded substantial clinically significant results in reducing migraine-related disability and a clinically though not statistically significant decrease in MHDs. Future work should examine how to implement this treatment into the ED workflow and make it more accessible to patients.