Randomized pilot trial for the efficacy of the MMF07 foot massager and heat therapy for restless legs syndrome.
Adult
Aged
Female
Foot
/ physiopathology
Hot Temperature
/ therapeutic use
Humans
Hyperthermia, Induced
/ methods
Male
Massage
/ methods
Middle Aged
Pain Management
/ methods
Pilot Projects
Prospective Studies
Quality of Life
Restless Legs Syndrome
/ therapy
Severity of Illness Index
Sleep
/ physiology
Treatment Outcome
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2020
2020
Historique:
received:
20
09
2019
accepted:
09
03
2020
entrez:
3
4
2020
pubmed:
3
4
2020
medline:
7
7
2020
Statut:
epublish
Résumé
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. 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. 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). Results suggest that the MMF07 foot massage device and heat therapy may be feasible and effective treatment options to improve RSL symptoms.
Sections du résumé
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.
Identifiants
pubmed: 32240228
doi: 10.1371/journal.pone.0230951
pii: PONE-D-19-26201
pmc: PMC7117678
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0230951Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR002733
Pays : United States
Déclaration de conflit d'intérêts
While we received funding from MedMassager, this does not alter our adherence to PLOS ONE policies on sharing data and material.
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