Kuhn Phyllis J, Olson Daniel J, Sullivan John P
J Am Osteopath Assoc. 2016 Jul 1;116(7):440-50. doi: 10.7556/jaoa.2016.088.
Restless legs syndrome (RLS) treatments have included medications with many adverse effects and limited utility. A noninvasive device would potentially have extensive use where RLS medications may not be appropriate, such as in pregnant or breastfeeding women, people with mild RLS, people who operate machinery or drive occupationally, people with severely impaired renal function, or people who are taking medications contraindicated with RLS medications.
To assess the efficacy and safety of a device that produces targeted pressure on the abductor hallucis and the flexor hallucis brevis muscles to reduce the symptoms of moderate to severe RLS, and to compare the current findings with findings from studies of ropinirole use in patients with primary RLS.
This 8-week single-arm, open-label, clinical trial with a repeated measures design was conducted between April 2009 and August 2012 in 2 offices in Erie, Pennsylvania. Adults with moderate to severe primary RLS were recruited for the study. Mean (SD) follow-up was 15.6 (6) months. Patients wore RLS devices (1 on each foot) for set periods intermittently throughout the course of the study. The primary end point was mean change in the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale from baseline to day 56, and the secondary measure was the Clinical Global Impression scale. A meta-analysis was used to compare the RLS device findings with the findings of 3 historic studies of ropinirole vs placebo. The demographics, disease severity, inclusion and exclusion criteria, and assessment tools were similar among the 4 studies.
Thirty patients (22 women, 8 men; mean age, 51.5 years [range, 30-75 years]) participated in the study. Change in mean (SD) IRLSSG score was significantly greater for the RLS device (17.22 [6.16]; P<.001) compared with the ropinirole vs placebo findings (12 [0.86] vs 8.9 [0.86], respectively; P<.05). Sleep loss significantly decreased from 119.5 (61.6) minutes to 22.1 (31.1) minutes per night (P<.001). Global Improvement Scale scores indicated significantly greater improvement with the RLS device compared with ropinirole (27 of 30 [90%] vs 293 of 464 [63%], respectively; P<.05). Mild, transient adverse effects of the device (eg, pain, paresthesia) were reported, but these effects were relieved by loosening the straps. The RLS device demonstrated none of the adverse effects associated with current dopamine agonist therapy, such as augmentation, tolerance, rebound, somnolence, and nausea.
Producing targeted pressure on the abductor hallucis and flexor hallucis brevis muscles with an external RLS device reduced the symptoms of moderate to severe primary RLS without the adverse effects of medication therapy. (ClinicalTrials.gov number NCT02386423.) J Am Osteopath Assoc.
不安腿综合征（RLS）的治疗方法包括使用有许多副作用且效用有限的药物。一种非侵入性设备可能会在RLS药物不适用的情况下得到广泛应用，比如孕妇或哺乳期妇女、轻度RLS患者、从事机械操作或职业驾驶的人、肾功能严重受损的人，或者正在服用与RLS药物有禁忌的药物的人。
评估一种对拇展肌和拇短屈肌产生靶向压力以减轻中重度RLS症状的设备的疗效和安全性，并将当前研究结果与原发性RLS患者使用罗匹尼罗的研究结果进行比较。
这项为期8周的单臂、开放标签、具有重复测量设计的临床试验于2009年4月至2012年8月在宾夕法尼亚州伊利的2个办公室进行。招募了患有中重度原发性RLS的成年人参与研究。平均（标准差）随访时间为15.6（6）个月。在研究过程中，患者间歇性地佩戴RLS设备（每只脚佩戴1个）一段设定的时间。主要终点是国际不安腿综合征研究组（IRLSSG）评分量表从基线到第56天的平均变化，次要指标是临床总体印象量表。采用荟萃分析将RLS设备的研究结果与3项罗匹尼罗与安慰剂对比的历史研究结果进行比较。4项研究中的人口统计学、疾病严重程度、纳入和排除标准以及评估工具相似。
30名患者（22名女性，8名男性；平均年龄51.5岁[范围30 - 75岁]）参与了研究。与罗匹尼罗与安慰剂的研究结果（分别为12[0.86]和8.9[0.86]；P<0.05）相比，RLS设备的平均（标准差）IRLSSG评分变化显著更大（17.22[6.16]；P<0.001）。每晚的睡眠缺失从119.5（61.6）分钟显著减少至22.1（31.1）分钟（P<0.001）。总体改善量表评分表明，与罗匹尼罗相比，RLS设备带来的改善显著更大（分别为30名中的27名[90%]和464名中的293名[63%]；P<0.05）。报告了该设备的轻度、短暂不良反应（如疼痛、感觉异常），但通过松开绑带这些影响得到缓解。RLS设备未表现出与当前多巴胺激动剂疗法相关的不良反应，如症状加重、耐受性、反跳、嗜睡和恶心。
使用外部RLS设备对拇展肌和拇短屈肌产生靶向压力可减轻中重度原发性RLS的症状，且无药物治疗的不良反应。（ClinicalTrials.gov编号NCT02386423。）《美国骨病协会杂志》
