Clinical trial NCT02526277: A Study on the Use of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Official title: A Randomized Prospective Study on the Efficacy of the MMF07 Foot Massager and Heat Therapy Treatments for Restless Leg Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Keywords: RLS
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: MedMassager
First posted: 2015-08-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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 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.

Eligibility 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

Primary outcomes:
measure: The International Restless Legs Severity Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: The Restless Legs Quality of Life Questionnaire
timeFrame: 4 weeks
measure: Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ariane Park, MD
role: PRINCIPAL_INVESTIGATOR
References: