N/A
Completed N=28
A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Source: ClinicalTrials.gov NCT02526277 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: The International Restless Legs Severity Scale — 17.3; 12.3; 16.9; 21.3 score on a scale
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The International Restless Legs Severity Scale |
17.3; 12.3; 16.9; 21.3 | — |
| SECONDARY The Restless Legs Quality of Life Questionnaire |
82.4; 66.7; 74.2; 57.1 | — |
| SECONDARY Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4 |
26.6; 31.2; 37.0; 48.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT02526277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.