Restless Leg SyndromeRESTIFFICNCT02386423
RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome
A study testing RESTIFFIC™ Brand Pressure Application System in people with Restless Leg Syndrome, run by Lake Erie Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Restless Leg Syndrome
- What is being tested?
- RESTIFFIC™ Brand Pressure Application System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Baycity Associated in Podiatry Inc
Erie, Pennsylvania, 16509
About this study
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
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.
Read the 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
- Being tested
- RESTIFFIC™ Brand Pressure Application System
- Keywords
- RLS, Willis-Ekbom
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTIFFIC™ Brand Pressure Application SystemDevice
Also called Restless Leg Relaxer
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).
| Study group | Role | What they receive |
|---|---|---|
| RESTIFFIC | Experimental | RESTIFFIC™ Brand Pressure Application System Receives: Device: RESTIFFIC™ Brand Pressure Application System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Restless Legs Syndrome Study Rating Scale
Measured: Change in International RLS Study Group (IRLSS) Rating Scale from baseline to Day 56 Study end
Secondary outcomes (1)
Clinical Global Impression Scale
Measured: Four CGI Scales, one each on Days, 1, 29, 36, and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Restless Leg SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lake Erie Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phyllis J Kuhn, PhD, Study director, Lake Erie Research InstituteDaniel J Olson, DPM, AACFAS, Principal investigator, Baycity Associates in Podiatry Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386423
- Sponsor's protocol ID
- Sorg1
- Acronym
- RESTIFFIC
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16438474Trenkwalder 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.
PubMed 14707315Walters 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.
PubMed 15390050Kuhn 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.
PubMed 27367949
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02386423
- Acronym / sponsor ID
- RESTIFFIC / Sorg1
- Conditions
- Restless Leg Syndrome
- Keywords
- RLS, Willis-Ekbom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lake Erie Research InstituteUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RESTIFFIC | Experimental | Device: RESTIFFIC™ Brand Pressure Application SystemRESTIFFIC™ Brand Pressure Application System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESTIFFIC™ Brand Pressure Application SystemAlso: Restless Leg RelaxerThe 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). | Device | RESTIFFIC |
Primary outcome
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
1 secondary outcome
Clinical Global Impression Scale
Time frame: Four CGI Scales, one each on Days, 1, 29, 36, and 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Background: PubMed 16438474Bogan 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.
- Background: PubMed 14707315Trenkwalder 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.
- Background: PubMed 15390050Walters 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.
- Derived from this study: PubMed 27367949Kuhn 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.
Related trials for Restless Leg Syndrome
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis J Kuhn, PhD study director
Lake Erie Research Institute
Daniel J Olson, DPM, AACFAS principal investigator
Baycity Associates in Podiatry Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTIFFIC™ Brand Pressure Application System in people with Restless Leg Syndrome, run by Lake Erie Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386423, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.