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

NCT02526277 | Completed Results

• 1 other identifier: 2015H0107
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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. 1.MMF07 Foot Massager device
2. 2.Heat therapy
3. 3.Heat therapy and the MMF07 Foot Massage device
4. 4.Neither heat nor MMF07 Foot Massager device (no treatment group)

Conditions

Restless Legs Syndrome

Keywords

RLS

Outcome Measures

Primary Outcomes (1)

• The International Restless Legs Severity Scale

  Participants answer a series of 10 questions each of which have values ranging from 0 to 4, the points are then added together. Higher values are associated with more severe symptoms; up to a maximum severity score of 40 points and a minimum severity of 0 points.

  4 weeks

Secondary Outcomes (2)

• The Restless Legs Quality of Life Questionnaire

  4 weeks

• Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4

  4 weeks

Study Arms (4)

MMF07 Foot Massager device

ACTIVE COMPARATOR

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.

Device: MMF07 Foot Massager

Heat therapy

ACTIVE COMPARATOR

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.

Device: Heat Therapy

MMF07 Foot Massager device and heat therapy

ACTIVE COMPARATOR

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.

Device: MMF07 Foot Massager; Device: Heat Therapy

No treatment

NO INTERVENTION

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

Interventions

MMF07 Foot Massager DEVICE

MMF07 Foot Massager device; MMF07 Foot Massager device and heat therapy

Heat Therapy DEVICE

Heat therapy; MMF07 Foot Massager device and heat therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ariane Park: lead
• MedMassager: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Results Point of Contact

• Title: Ariane Park, MD
• Organization: The Ohio State University

Ariane.Park@osumc.edu

614.293.4969

Study Officials

• Ariane Park, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: August 18, 2015
• Study Start: January 6, 2016
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: January 28, 2021
• Results First Posted: February 18, 2020

Record last verified: 2021-01

Locations

US (1)