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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02526277
Recruitment Status : Completed
First Posted : August 18, 2015
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
MedMassager
Information provided by (Responsible Party):
Ariane Park, Ohio State University

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;

  1. MMF07 Foot Massager device
  2. Heat therapy
  3. Heat therapy and the MMF07 Foot Massage device
  4. 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects between 18-75 years old diagnosed with RLS according to the diagnostic criteria of the International Restless Legs Syndrome Study Group (11)
  2. Subjects should have bothersome RLS symptoms, despite best medical therapy
  3. Subjects should be stable on all RLS medication for at least 4 weeks prior to enrollment
  4. All subjects must have vision and be proficient in English for compliance with testing and surveys
  5. 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:

  1. RLS secondary associated with end stage renal disease, iron deficiency or pregnancy
  2. Concomitant sleep disorders
  3. Any other condition (other than the primary indications), which in the opinion of the investigators might contribute to difficulty complying with the protocol

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Ariane Park
MedMassager
Investigators
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Principal Investigator: Ariane Park, MD Ohio State University
  Study Documents (Full-Text)

Documents provided by Ariane Park, Ohio State University:
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Responsible Party: Ariane Park, MD, MPH, Ohio State University
ClinicalTrials.gov Identifier: NCT02526277    
Other Study ID Numbers: 2015H0107
First Posted: August 18, 2015    Key Record Dates
Results First Posted: February 18, 2020
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ariane Park, Ohio State University:
RLS
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders