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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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ClinicalTrials.gov Identifier: NCT02526277
Recruitment Status : Active, not recruiting
First Posted : August 18, 2015
Last Update Posted : October 12, 2018
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 Phase 3

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: Treatment
Official Title: A Randomized Prospective Study on the Efficacy of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Study Start Date : July 2015
Estimated Primary Completion Date : July 2019

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. Evaluating severity of RLS symptoms using the International Restless Legs Severity Scale. [ Time Frame: Baseline to 4 weeks ]
    Participants will be asked to 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.


Secondary Outcome Measures :
  1. Evaluating changes in quality of life using the Restless Legs Quality of Life Questionnaire. [ Time Frame: Baseline to 4 weeks ]
    Participants will be asked to answer a series of 18 questions that are scored such that lower scores indicate worse quality of life.

  2. Evaluating changes in sleep as measured by the Medical Outcomes Sleep Study scale. [ Time Frame: Baseline to 4 weeks ]
    Participants will be asked to answer a series of 12 questions assessing quality of sleep, with values ranging from 1 to 6.



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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

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Responsible Party: Ariane Park, MD, MPH, Ohio State University
ClinicalTrials.gov Identifier: NCT02526277     History of Changes
Other Study ID Numbers: 2015H0107
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Keywords provided by Ariane Park, Ohio State University:
RLS

Additional relevant MeSH terms:
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Syndrome
Psychomotor Agitation
Restless Legs 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