Back to resultsA Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Primary Purpose
Restless Legs Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MMF07 Foot Massager
Heat Therapy
Sponsored by
About this trial
This is an interventional other trial for Restless Legs Syndrome focused on measuring RLS
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
Sites / Locations
- Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
MMF07 Foot Massager device
Heat therapy
MMF07 Foot Massager device and heat therapy
No treatment
Arm Description
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.
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.
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.
Participants receiving no intervention will be asked to not alter their nighttime routine.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT02526277
First Posted
July 22, 2015
Last Updated
January 8, 2021
Sponsor
Ariane Park
Collaborators
MedMassager
1. Study Identification
Unique Protocol Identification Number
NCT02526277
Brief Title
A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Official Title
A Randomized Prospective Study on the Efficacy of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2016 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ariane Park
Collaborators
MedMassager
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
Keywords
RLS
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMF07 Foot Massager device
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Heat therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MMF07 Foot Massager device and heat therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Participants receiving no intervention will be asked to not alter their nighttime routine.
Intervention Type
Device
Intervention Name(s)
MMF07 Foot Massager
Intervention Type
Device
Intervention Name(s)
Heat Therapy
Primary Outcome Measure Information:
Title
The International Restless Legs Severity Scale
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The Restless Legs Quality of Life Questionnaire
Description
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).
Time Frame
4 weeks
Title
Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariane Park, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
12. IPD Sharing Statement
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A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
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