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

NCT ID: NCT02526277

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-06
• Study Completion Date: 2018-09-25

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.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

MMF07 Foot Massager device

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.

Group Type: ACTIVE_COMPARATOR

MMF07 Foot Massager

Intervention Type: DEVICE

Heat therapy

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.

Group Type: ACTIVE_COMPARATOR

Heat Therapy

Intervention Type: DEVICE

MMF07 Foot Massager device and heat therapy

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.

Group Type: ACTIVE_COMPARATOR

MMF07 Foot Massager

Intervention Type: DEVICE

Heat Therapy

Intervention Type: DEVICE

No treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MMF07 Foot Massager

Intervention Type: DEVICE

Heat Therapy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedMassager

UNKNOWN

Sponsor Role: collaborator

Ariane Park

OTHER

Sponsor Role: lead

Responsible Party

Ariane Park

MD, MPH

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ariane Park, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015H0107

Identifier Type: -

Identifier Source: org_study_id