A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
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|ClinicalTrials.gov Identifier: NCT02526277|
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
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)
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome||Device: MMF07 Foot Massager Device: Heat Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||A Randomized Prospective Study on the Efficacy of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome|
|Actual Study Start Date :||January 6, 2016|
|Actual Primary Completion Date :||September 25, 2018|
|Actual Study Completion Date :||September 25, 2018|
Active Comparator: 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.
Device: MMF07 Foot Massager
Active Comparator: 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.
Device: Heat Therapy
Active Comparator: 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.
Device: MMF07 Foot Massager
Device: Heat Therapy
No Intervention: No treatment
Participants receiving no intervention will be asked to not alter their nighttime routine.
- The International Restless Legs Severity Scale [ Time Frame: Baseline to 4 weeks: Average change score compared to Control/No treatment group ]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.
- The Restless Legs Quality of Life Questionnaire [ Time Frame: Baseline to 4 weeks ]Participants answer a series of 18 questions that are scored such that lower scores indicate worse quality of life. The scoring process for the RLSQoL is relatively complicated. Items 1-5, 7-10, and 13 use scales ranging from 1 to 5, with lower scores indicating a greater frequency and interference of restless legs syndrome. The total score for these items is converted to a value between 0 and 100 using an algorithm provided along with the scale. Items 6 and 16-18 require respondents to indicate how many days in the previous month or hours in the previous day they have been able to complete certain activities or have had their daily functioning interfered with. These items are scored as continuous variables (for example, ranging from 0 to 28 days for questions regarding the number of days per month). Items 11, 12, 14, and 15 are categorical variables, where a response of "yes" receives (a 1), a response of "no" receives (a 2), and a response of "not applicable receives (3a).
- Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4 From Baseline. [ Time Frame: Baseline to 4 weeks ]The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Medical Outcomes Sleep Study scale: Participants answer a series of 12 questions assessing quality of sleep, with values ranging from 1 to 6. The lower the score the more severe the sleep disturbance(s); higher the score the better the sleep quality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526277
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43221|
|Principal Investigator:||Ariane Park, MD||Ohio State University|