RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome (RESTIFFIC)
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|ClinicalTrials.gov Identifier: NCT02386423|
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Restless Leg Syndrome||Device: RESTIFFIC™ Brand Pressure Application System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2009|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||November 2011|
RESTIFFIC™ Brand Pressure Application System
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).
Other Name: Restless Leg Relaxer
- 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 ]
- Clinical Global Impression Scale [ Time Frame: Four CGI Scales, one each on Days, 1, 29, 36, and 57 ]
- 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 ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386423
|United States, Pennsylvania|
|Baycity Associated in Podiatry Inc|
|Erie, Pennsylvania, United States, 16509|
|Study Director:||Phyllis J Kuhn, PhD||Lake Erie Research Institute|
|Principal Investigator:||Daniel J Olson, DPM, AACFAS||Baycity Associates in Podiatry Inc|