RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Restless Leg Syndrome

Intervention / Treatment
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* Device: RESTIFFIC™ Brand Pressure Application System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RESTIFFIC<br>RESTIFFIC™ Brand Pressure Application System | Device: RESTIFFIC™ Brand Pressure Application System<br>* 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).<br>* Other names: Restless Leg Relaxer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Restless Legs Syndrome Study Rating Scale |  | Change in International RLS Study Group (IRLSS) Rating Scale from baseline to Day 56 Study end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale |  | Four CGI Scales, one each on Days, 1, 29, 36, and 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RLS, Willis-Ekbom