A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Completed · Not applicable
Conditions studied: Restless Legs Syndrome
In brief
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)
Key facts
- Study ID
- NCT02526277
- Run by
- Ariane Park
- People needed
- 28
- Starts
- 2016-01-06
- Expected to finish
- 2018-09-25
- Last updated by the study team
- 2021-01-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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