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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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)

Detailed Summary:

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.


Sponsor: Ariane Park

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: July 22, 2015
Date Started: July 2015
Date Completion:
Last Updated: September 26, 2016
Last Verified: September 2016