A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome

Study Overview
=================
Brief Summary
-----------------
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)

Detailed Description
-----------------
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.

Official Title
-----------------
A Randomized Prospective Study on the Efficacy of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Device: MMF07 Foot Massager
* Device: Heat Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MMF07 Foot Massager device<br>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<br> <br> |
| Active Comparator: Heat therapy<br>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<br> <br> |
| Active Comparator: MMF07 Foot Massager device and heat therapy<br>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<br> <br> Device: Heat Therapy<br> <br> |
| No Intervention: No treatment<br>Participants receiving no intervention will be asked to not alter their nighttime routine. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The International Restless Legs Severity Scale | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Restless Legs Quality of Life Questionnaire | 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). | 4 weeks | 
| Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4 | Participants answered a series of 12 questions assessing sleep, with values ranging from 1 to 6, and an additional dichotomous indicator of optimal sleep. All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is then converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. Reference: Spritzer, K. L. & Hays, R. D. (2003, November). MOS Sleep Scale: A Manual for Use and Scoring, Version 1.0. Los Angeles, CA. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RLS