Department of Neurology, Madden Center for Parkinson's Disease and Related Disorders, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.
Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.
PLoS One. 2020 Apr 2;15(4):e0230951. doi: 10.1371/journal.pone.0230951. eCollection 2020.
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.
不宁腿综合征（RLS）是一种具有广泛严重程度的感觉运动疾病。症状会对睡眠和生活质量产生负面影响。药物治疗选择并不普遍有效，且常见副作用。关于非药物治疗的客观数据有限。本研究的目的是评估 MMF07 足部按摩器和热疗对 RLS 症状严重程度的疗效。
在这项先导随机对照试验中，28 名诊断为有症状的 RLS 患者被随机分为四组治疗：无主动干预（n = 7）、足部按摩器（n = 8）、热疗（n = 6）和足部按摩器加热疗（n = 7）。参与者在基线访视和 4 周随访时完成 RLS 严重程度量表、RLS 生活质量问卷和医疗结局研究睡眠量表。
随机分组后 4 周，按摩组的 RLS 严重程度评分（平均差异：-9.0，95%置信区间：-16.3，-1.7，p = 0.017）和睡眠量表（平均差异：-22.0，95%置信区间：-36.5，-7.5，p = 0.005）与无干预组相比有显著改善。单独使用热疗与无干预组相比，睡眠量表有显著改善（平均差异：-17.4，95%置信区间：-32.5，-2.3，p = 0.026）。与对照组相比，仅按摩组的生活质量有所改善（平均差异 25.3，95%置信区间：-2.4，53.0，p = 0.072）。
结果表明，MMF07 足部按摩器和热疗可能是改善 RLS 症状的可行且有效的治疗选择。
