Smartphone Progressive Muscle Relaxation Shows Benefit as Migraine Therapy

Mia Minen, MD, MPH

Results from a pilot study suggest that smartphone-delivered progressive muscle relaxation (PMR) may be an acceptable and accessible form of therapy for patients with migraine after showing a small-moderate mean effect size in disability scores.¹

The non-blinded, randomized, parallel-arm, controlled trial featured 139 participants with migraine with ≥4 headache days/month who were given the RELAXaHEAD smartphone application which includes an electronic headache diary over the 90-day study period. The app was developed in part by NYU School of Medicine researchers.

The study, led by author Mia Minen, MD, MPH, assistant professor of neurology and director of headache services, NYU Langone, and colleagues measured feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). Patients were randomized to receive either a version of the app with PMR or without PMR.

Acceptability measures were collected on satisfaction using 5-point Likert scale questions on the app’s ability, content, and functionality. Using that scale, those included in the study found the app to be easy to use (mean, 4.2 [±0.7]) and stated they would be happy to engage in PMR intervention again (mean, 4.3 [±0.6]).

The app’s PMR intervention includes a 5-minute (short) session and 15-minute (long) session as well as back-end analytics to capture time spent engaging with the app. Investigators noted that previously reported data from a single-arm study of the feasibility of RELAXaHEAD showed that people with migraine in a tertiary care neurology practice were willing to practice PMR for up to 6 weeks and that there may be a dose-dependent relationship in effect of the PMR.

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Minen and colleagues also conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days. Relative to the diary-only group, patients in the PMR group showed a greater nonsignificant decline in mean MIDAS scores (–8.7 vs –22.7; P = .100) corresponding to a small-moderate mean effect size (Cohen’s d = 0.38).

There was no relationship between PMR dose and MIDAS score at 3 months (Spearman correlation coefficient = 0.08; P = .618). After accounting for within-person correlation, the odds of having a headache day in the PMR arm compared to the control arm over the 90-day period was 2.1 (95% CI, 1.002–4.566; P = .047).

Participants in the study played the PMR for a mean duration of 11.1 (±8.3) minutes with an average of 19.2 (±16.6) median days during the 90-day study period. The level of PMR use declined after 6 weeks, but until that point, participants practiced PMR 2–4 days a week.

Practice of the PMR was done on days where patients had headaches as well as headache-free days. Notably, 54% of the days used with PMR were reported as headache-free whereas the remaining 46% were headache positive days.

The average number of times with 3 consecutive days of lack of adherence was 2.2 (±2.7) days in the PMR group and 1.3 (±2.6) days in the diary-only group. Using prediction models, investigators found that gender, age at first headache, and race were the most predictive variables for diary use. All 3 of these variables were statistically significant with high frequency of diary use per week. Investigators noted though that none of these predictors had a statistically significant association with PMR use.

Minen et al concluded, “Future studies may focus on implementation studies to examine how to best offer the app to patients. Furthermore, future studies might examine whether the other level A evidence-based behavioral therapies (CBT and biofeedback) might be introduced for migraine prevention in the primary care setting.”

The use of smartphones to treat patients with migraine have become more popular as telemedicine and telehealth practices have evolved. In October, the FDA cleared the Nerivio medical device for an expansion on its treatment indication to include the acute treatment of chronic migraine in patients aged 18 years and older. The user-friendly app for the device offers personalized treatments and includes a diary to track treatment sessions and migraine headaches.²

REFERENCES

1. Minen MT, Adhikari S, Padikkala J, et al. Smartphone-delivered progressive muscle relaxation for the treatment of migraine in primary care: a randomized controlled trial. Headache. Published online November 16, 2020. doi: 10.1111/head.14010

2. Nerivio receives clearance of expanded indication to cover chronic migraine patients. News release. Theranica Biotherapeutics. Published October 26, 2020. Accessed November 30, 2020. prnewswire.com/news-releases/nerivio-receives-clearance-of-expanded-indication-to-cover-chronic-migraine-patients-301159445.html