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

Ariane Park

Status: Completed

Conditions: Restless Legs Syndrome

Treatments: Device: MMF07 Foot Massager; Device: Heat Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02526277

2015H0107

Details and patient eligibility

About

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)

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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28 participants in 4 patient groups

MMF07 Foot Massager device

Active Comparator group

Description:

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.

Treatment:

Device: MMF07 Foot Massager

Heat therapy

Active Comparator group

Description:

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.

Treatment:

Device: Heat Therapy

MMF07 Foot Massager device and heat therapy

Active Comparator group

Description:

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.

Treatment:

Device: MMF07 Foot Massager

Device: Heat Therapy

No treatment

No Intervention group

Description:

Participants receiving no intervention will be asked to not alter their nighttime routine.