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RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome (RESTIFFIC)

Primary Purpose

Restless Leg Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RESTIFFIC™ Brand Pressure Application System

About this trial

This is an interventional treatment trial for Restless Leg Syndrome focused on measuring RLS, Willis-Ekbom

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Otherwise healthy adults between the ages of 18 and 75 years who were diagnosed with moderate to severe RLS were recruited from Erie and the surrounding regions. The patient was examined by the physician and screened using the medical history, the International RLS study group diagnostic criteria, and International RLS Study (IRLSS) Rating Scale.

To be included, patients had to have: (1) a total score of 15 or greater on the International RLS Rating Scale; (2) evening and nighttime symptoms with sleep impairment (by self-report) due to RLS; and (3) RLS for at least six months with symptoms at least two to three times per week. The potential was for at least 12 and as many as 42 episodes of RLS during the treatment period.

Exclusion Criteria:

The patient was excluded if he/she had any serious medical conditions or conditions that may have presented a safety concern or that may have impacted efficacy assessment, eg, taking drugs like antidepressants known to affect RLS. Medical conditions included, but were not limited to: claudication, nerve problems, fragile, thin skin, impaired wound healing; poor circulation, injury to feet or legs, movement problems, inability to sit still or remain motionless, involuntary movements similar to a tic, sleep disorders, parasomnias involving abnormal movements, narcolepsy, obstructive sleep apnea, nighttime discomfort not due to RLS, secondary RLS, or Parkinson's Disease. Patients on drug treatment for RLS must have been discontinued treatment for at least 30 days. (Note: None of our patients were on drug treatment for RLS.) Through history and physical examination, the physician distinguished RLS from other disorders such as periodic Limb Movement Disorder (footnote 5)

Sites / Locations

Baycity Associated in Podiatry Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RESTIFFIC

Arm Description

RESTIFFIC™ Brand Pressure Application System

Outcomes

Primary Outcome Measures

Change in International Restless Legs Syndrome Study Rating Scale

Secondary Outcome Measures

Clinical Global Impression Scale

Full Information

NCT ID

NCT02386423

First Posted

March 2, 2015

Last Updated

March 5, 2015

Sponsor

Lake Erie Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02386423

Brief Title

RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome

Acronym

RESTIFFIC

Official Title

Efficacy and Safety of the RESTIFFIC™ Brand Pressure Application System, the Restless Leg Relaxer to Reduce the Symptoms of Moderate to Severe Restless Leg Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lake Erie Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap that produces adjustable targeted pressure on specific muscles in the feet, to reduce the symptoms of moderate to severe primary Restless Legs Syndrome.

Detailed Description

Restless legs syndrome (RLS), or Willis-Ekbom Disease, is a neurologic disorder causing unpleasant sensations and an urge to move the legs when the person is at rest. The sensations are relieved by movement. Loss of sleep associated with RLS can cause extreme fatigue, affecting concentration, which may produce anxiety and depression, resulting in a poor quality of life. Prevalence in the general population is 5% to 10%. In approximately 3%, symptoms are so severe that treatment is sought. Potent drugs, such as opioids, central nervous system depressants, anticonvulsants, and dopamine agonists have been used to ease symptoms, each with several side effects. Anecdotal evidence suggested that pressure on specific foot muscles decreases symptoms of moderate to severe primary restless legs syndrome. In the RESTIFFIC™ study, patients served as their own negative controls, wearing the RESTIFFIC™ devices intermittently, while completing surveys related to RLS throughout the study. Physicians also completed surveys related to quality of life. Meta-analysis was used to compare RESTIFFIC™ to historic reports of ropinirole and placebo pill. Demographics, disease severity,inclusion/exclusion criteria, assessment tools were similar among studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Leg Syndrome

Keywords

RLS, Willis-Ekbom

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RESTIFFIC

Arm Type

Experimental

Arm Description

RESTIFFIC™ Brand Pressure Application System

Intervention Type

Device

Intervention Name(s)

RESTIFFIC™ Brand Pressure Application System

Other Intervention Name(s)

Restless Leg Relaxer

Intervention Description

The device, RESTIFFIC™, was administered intermittently through the course of the study: one-week baseline period without the device (days 1-7), three weeks of initial testing with the device (days 8-28), a subsequent one-week period without the device (days 29-35), and three weeks of subsequent testing with the device (days 36-56).

Primary Outcome Measure Information:

Title

Change in International Restless Legs Syndrome Study Rating Scale

Time Frame

Change in International RLS Study Group (IRLSS) Rating Scale from baseline to Day 56 Study end

Secondary Outcome Measure Information:

Title

Clinical Global Impression Scale

Time Frame

Four CGI Scales, one each on Days, 1, 29, 36, and 57

Other Pre-specified Outcome Measures:

Title

Meta-analysis used to compare change in IRLSS scores in RESTIFFIC to change in IRLSS scores for ropinirole and placebo pill (historic reports)

Time Frame

Baseline to end of study

Title

Number and type of adverse events as a measure of safety and tolerability of RESTIFFIC™ vs ropinirol and placebo (historic reports)

Time Frame

Baseline to study end.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Otherwise healthy adults between the ages of 18 and 75 years who were diagnosed with moderate to severe RLS were recruited from Erie and the surrounding regions. The patient was examined by the physician and screened using the medical history, the International RLS study group diagnostic criteria, and International RLS Study (IRLSS) Rating Scale. To be included, patients had to have: (1) a total score of 15 or greater on the International RLS Rating Scale; (2) evening and nighttime symptoms with sleep impairment (by self-report) due to RLS; and (3) RLS for at least six months with symptoms at least two to three times per week. The potential was for at least 12 and as many as 42 episodes of RLS during the treatment period. Exclusion Criteria: The patient was excluded if he/she had any serious medical conditions or conditions that may have presented a safety concern or that may have impacted efficacy assessment, eg, taking drugs like antidepressants known to affect RLS. Medical conditions included, but were not limited to: claudication, nerve problems, fragile, thin skin, impaired wound healing; poor circulation, injury to feet or legs, movement problems, inability to sit still or remain motionless, involuntary movements similar to a tic, sleep disorders, parasomnias involving abnormal movements, narcolepsy, obstructive sleep apnea, nighttime discomfort not due to RLS, secondary RLS, or Parkinson's Disease. Patients on drug treatment for RLS must have been discontinued treatment for at least 30 days. (Note: None of our patients were on drug treatment for RLS.) Through history and physical examination, the physician distinguished RLS from other disorders such as periodic Limb Movement Disorder (footnote 5)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phyllis J Kuhn, PhD

Organizational Affiliation

Lake Erie Research Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Daniel J Olson, DPM, AACFAS

Organizational Affiliation

Baycity Associates in Podiatry Inc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baycity Associated in Podiatry Inc

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16509

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16438474

Citation

Bogan RK, Fry JM, Schmidt MH, Carson SW, Ritchie SY; TREAT RLS US Study Group. Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial. Mayo Clin Proc. 2006 Jan;81(1):17-27. doi: 10.4065/81.1.17.

Results Reference

background

PubMed Identifier

14707315

Citation

Trenkwalder C, Garcia-Borreguero D, Montagna P, Lainey E, de Weerd AW, Tidswell P, Saletu-Zyhlarz G, Telstad W, Ferini-Strambi L; Therapy with Ropiunirole; Efficacy and Tolerability in RLS 1 Study Group. Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):92-7.

Results Reference

background

PubMed Identifier

15390050

Citation

Walters AS, Ondo WG, Dreykluft T, Grunstein R, Lee D, Sethi K; TREAT RLS 2 (Therapy with Ropinirole: Efficacy And Tolerability in RLS 2) Study Group. Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord. 2004 Dec;19(12):1414-23. doi: 10.1002/mds.20257.

Results Reference

background

PubMed Identifier

27367949

Citation

Kuhn PJ, Olson DJ, Sullivan JP. Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome. J Am Osteopath Assoc. 2016 Jul 1;116(7):440-50. doi: 10.7556/jaoa.2016.088.

Results Reference

derived

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RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome

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