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Randomized Controlled Trial
. 2020 Nov;60(10):2232-2246.
doi: 10.1111/head.14010. Epub 2020 Nov 16.

Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial

Mia T Minen  1   2 , Samrachana Adhikari  2 , Jane Padikkala  3 , Sumaiya Tasneem  3 , Ashley Bagheri  3 , Eric Goldberg  4 , Scott Powers  5 , Richard B Lipton  6   7   8
Affiliations
Randomized Controlled Trial

Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial

Mia T Minen et al. Headache. 2020 Nov.

Erratum in

  • Erratum.
    [No authors listed] [No authors listed] Headache. 2021 Jun;61(6):976. doi: 10.1111/head.14064. Epub 2021 Feb 8. Headache. 2021. PMID: 34214186 No abstract available.

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.

Keywords: behavioral medicine; mHealth; migraine; primary care; relaxation.

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Figures

Fig. 1.
Fig. 1.
Flow diagram.
Fig. 2.
Fig. 2.
Characterizing diary and PMR use.
See this image and copyright information in PMC

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