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Randomized Controlled Trial
. 2020 Apr 2;15(4):e0230951.
doi: 10.1371/journal.pone.0230951. eCollection 2020.

Randomized pilot trial for the efficacy of the MMF07 foot massager and heat therapy for restless legs syndrome

Ariane Park  1 , Katherine Ambrogi  1 , Erinn M Hade  2
Affiliations
Randomized Controlled Trial

Randomized pilot trial for the efficacy of the MMF07 foot massager and heat therapy for restless legs syndrome

Ariane Park et al. PLoS One. .

Abstract

Background: Restless Legs Syndrome (RLS) is a sensorimotor condition with a wide range of severity. Symptoms negatively affect sleep and quality of life. Pharmacologic options are not universally effective and side effects are common. Objective data regarding non-pharmacologic treatment is limited. The study objective was to evaluate the efficacy of the MMF07 foot massager and heat therapy on the severity of RLS symptoms.

Methods: In this pilot randomized controlled trial, twenty-eight patients with diagnosed, bothersome RLS were randomized to four treatment arms: no active intervention (n = 7), foot massager (n = 8), heat therapy (n = 6), and foot massager plus heat therapy (n = 7). Participants completed the RLS Severity Scale, RLS Quality of Life questionnaire, and the Medical Outcomes Study Sleep scale at the baseline visit and at the 4-week follow up visit.

Results: Four weeks post randomization, participants in the massager group had significant improvement in the RLS severity score (average difference: -9.0, 95% CI: -16.3, -1.7, p = 0.017) and sleep scale (average difference: -22.0, 95% CI: -36.5, -7.5, p = 0.005) compared to the no intervention group. The heat alone group had a significant improvement in the sleep scale compared to the no-intervention group (average difference: -17.4, 95% CI: -32.5, -2.3, p = 0.026). Quality of life improved in the massage only group compared to control (average difference 25.3, 95% CI: -2.4, 53.0, p = 0.072).

Conclusions: Results suggest that the MMF07 foot massage device and heat therapy may be feasible and effective treatment options to improve RSL symptoms.

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Conflict of interest statement

While we received funding from MedMassager, this does not alter our adherence to PLOS ONE policies on sharing data and material.

Figures

Fig 1
Fig 1. Flow of participants at each stage of the trial.
See this image and copyright information in PMC

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