NCT02386423

RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Lake Erie Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Restless Leg Syndrome

Interventions

Type	Name	Description
DEVICE	RESTIFFIC™ Brand Pressure Application System	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).

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-04-01
• Completion: 2011-11-01
• First posted: 2015-03-11
• Last updated: 2015-03-11

Locations

1 site across 1 country: United States