Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care

A Randomized Controlled Trial

Mia T. Minen, MD, MPH; Samrachana Adhikari, PhD; Jane Padikkala, MPH; Sumaiya Tasneem, MPH; Ashley Bagheri, MS; Eric Goldberg, MD; Scott Powers, PhD; Richard B. Lipton, MD

Disclosures

Headache. 2020;60(10):2232-2246. 

In This Article

Abstract and Introduction

Abstract

Objective: Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting.

Methods: This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days.

Results: Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7 ± 12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1–5 Likert scale, participants found the app easy to use (mean 4.2 ± 0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3 ± 0.6). For the first 6 weeks, participants practiced PMR 2–4 days/week. Mean per session duration was 11.1 ± 8.3 minutes. Relative to the diary-only group, the PMR group showed a greater non-significant 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).

Conclusion: Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.

Introduction

Healthcare utilization rates for migraine are high, with over 6 million ambulatory visits annually and greater than 50% of all of these visits occurring in primary care settings.[1] One out of every 10 primary care consultations is for headache, and migraine accounts for at least 75% of these headache visits.[2] Migraine preventive treatment can consist of preventive medication and/or behavioral therapy; combining modalities does better than either 1 alone.[3,4] The level A evidence-based behavioral therapies for migraine are cognitive behavioral therapy (CBT), biofeedback, and relaxation training, including progressive muscle relaxation (PMR).[5]

There are many barriers to adequate migraine treatment in the primary care setting, from under-diagnosis to under-treatment (under-prescribing of abortive medication and migraine preventive pharmacologic and behavioral therapy).[6–10] In the primary care setting, there is on average a 4-year delay between migraine diagnosis and the start of preventive pharmacologic treatment.[11] In a prior study of 83 academic PCPs, only about 40% knew that relaxation training is an evidence-based treatment for migraine,[9] and in another study of PCPs and migraine, 40% said that they refer for relaxation for migraine.[10] Even PCPs familiar with the evidence-based behavioral treatment options often refer to nonpharmacologic treatments with much less evidence for migraine prevention, such as physical therapy and psychoanalysis[10] because of the challenge PCPs and patients face in finding providers trained in evidence-based behavioral therapies for migraine.[10,12,13] Furthermore, even when people are referred for behavioral therapy for migraine, few people attend the behavioral therapy appointments.[14,15] Time and cost are frequently cited by patients as barriers to pursuing behavioral therapy for migraine.[14,15]

Effective, accessible, nonpharmacologic, prevention management strategies are needed to improve migraine management in the primary care setting. The RELAXaHEAD smartphone application (app) was developed in collaboration with Irody[16] and beta-tested by both headache specialists and people with migraine.[17] In brief, the RELAXaHEAD app contains a PMR intervention, one of the level A evidence-based treatments for migraine prevention. It also includes back-end analytics to capture time spent engaging with the PMR app on the smartphone. The PMR audio files within the app were developed for the Stress Management in Living with Epilepsy study;[18,19] there is an ~ 5-minute PMR (short) session and an ~ 15-minute (long) PMR session embedded in the app. 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 the effect of the PMR.[20] In this study, we asked participants to use the app daily to assess adherence and declining rates of use, accepting that adherence might be modest based on prior literature.[20,21]

Thus, we sought to conduct a 1:1 pilot randomized controlled feasibility and acceptability trial in patients with migraine in the primary care setting comparing smartphone-based PMR to monitored usual care (MUC). This was performed using the same RELAXaHEAD app. We hypothesized that our smartphone-based intervention would be feasible and acceptable, and that those who practiced PMR would have better preliminary migraine efficacy outcomes in terms of migraine disability and headache days.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....