A Randomized Prospective Study on the Efficacy of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The International Restless Legs Severity Scale
研究概览
简要总结
The purpose of this study is to assess whether the MMF07 Foot Massager and/ or heat therapy may improve symptoms of restless legs syndrome (RLS). It will also assess the effect of the MMF07 Foot Massager and/ or heat on quality of life and sleep in people affected by RLS. Participants will be randomly assigned to one of four treatment groups;
- MMF07 Foot Massager device
- Heat therapy
- Heat therapy and the MMF07 Foot Massage device
- Neither heat nor MMF07 Foot Massager device (no treatment group)
详细描述
Few clinical trials have looked into non-pharmacological, non-invasive treatments for restless legs syndrome, despite reports that massage, baths and vibrations can alleviate RLS symptoms. We would like to assess whether the MMF007 Foot Massager device and/or heat therapy is associated with improved severity of RLS symptoms.
For this study the investigator will enroll 40 participants who have been diagnosed with restless legs syndrome, who will be followed over the course of four weeks and asked to complete two in person study visits. In the study the investigator is comparing the use of the MMF007 Foot Massager device and/ or heat therapy to a non treatment group to assess if the symptoms of RLS improve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 18-75 years old diagnosed with RLS according to the diagnostic criteria of the International Restless Legs Syndrome Study Group (11)
- •Subjects should have bothersome RLS symptoms, despite best medical therapy
- •Subjects should be stable on all RLS medication for at least 4 weeks prior to enrollment
- •All subjects must have vision and be proficient in English for compliance with testing and surveys
- •All women of childbearing age must be using an acceptable form of birth control, including abstinence, intrauterine device (IUD) or intrauterine system in place for at least 3 months prior to screening, subject or partner using barrier method (e.g., condom, diaphragm, or cervical cap) with spermicide from screening through study completion; partner has a documented vasectomy > 6 months prior to Baseline, Stable hormonal contraception (with approved oral, transdermal, or depot regimen) for at least 3 months prior to screening
排除标准
- •RLS secondary associated with end stage renal disease, iron deficiency or pregnancy
- •Concomitant sleep disorders
- •Any other condition (other than the primary indications), which in the opinion of the investigators might contribute to difficulty complying with the protocol
研究组 & 干预措施
MMF07 Foot Massager device
Participants randomized to the MMF07 Foot Massager device arm will be provided the MMF07 Foot Massager device and instructed to set this device at setting 3, then increase or decrease the setting to their desired level of comfort, to be used for 30 minutes at bedtime.
干预措施: MMF07 Foot Massager (Device)
Heat therapy
Participants randomized to heat therapy will be provided an electric heating pad and will be instructed to use this pad at a medium setting for 30 minutes at bedtime.
干预措施: Heat Therapy (Device)
MMF07 Foot Massager device and heat therapy
Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.
干预措施: Heat Therapy (Device)
MMF07 Foot Massager device and heat therapy
Participants randomized to both the MMF07 Foot Massager device and heat therapy will be provided both the MMF07 Foot Massager device and electric heating pad. Participants will be instructed to set the MMF07 Foot Massager device at setting 3, then increase or decrease the setting to their desired level of comfort. They will also be instructed to use the electric heating pad at a medium setting at the same time for 30 minutes at bedtime.
干预措施: MMF07 Foot Massager (Device)
No treatment
Participants receiving no intervention will be asked to not alter their nighttime routine.
结局指标
主要结局
The International Restless Legs Severity Scale
时间窗: 4 weeks
Participants answer a series of 10 questions each of which have values ranging from 0 to 4, the points are then added together. Higher values are associated with more severe symptoms; up to a maximum severity score of 40 points and a minimum severity of 0 points.
次要结局
- The Restless Legs Quality of Life Questionnaire(4 weeks)
- Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4(4 weeks)
研究者
Ariane Park
MD, MPH
Ohio State University