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ID
Source
Brief title
Health condition
Restless Legs Syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
Visual Analog Scale on RLS symptoms (VAS).
Secondary outcome
RLS severity (IRLS), Sleep (MOS-sleep), Quality of Life (RLS-QoL) and Safety (Registering adverse reactions and serious adverse events).
Background summary
Restless Legs Syndrome (RLS) is a sensorimotor disorder characterized by an irresistible urge to move the legs to stop unpleasant sensations. These unpleasant sensations are usually experienced in the calves and range in severity from discomfort to painful. The exact cause of RLS remains unknown and there is no cure. Treatment is directed at symptom relief only, which can be achieved with pharmaceuticals or conservatively. Existing pharmacotherapy can only be administered to target specific patients, is not practical in every RLS triggering situation, and is not very popular due to the related adverse effects. Transcutaneous electrical nerve stimulation (TENS) is a safe non-pharmacological treatment modality for a variety of pain conditions and it has been shown that TENS can reduce symptoms of RLS. Therefore, to treat RLS with TENS could offer additional efficacy and improve the therapeutic repertoire for RLS, with fewer side effects. LEX0 is a novel TENS device designed to place on the calf, specifically for the treatment of RLS.
Study objective
LEX0 reduces symptoms of Restless Legs.
Study design
Before and after each treatment with LEX0: VAS
Visit 1 (begin study) : IRLS, MOS-sleep, RLS-QoL
Visit 2 (end study) : IRLS, MOS-sleep, RLS-QoL
Intervention
Subjects are instructed to use LEX0 for 4 weeks in home environment for their restless legs, as needed. An user manual is handed. In the event of an RLS attack, LEX0 is placed with the electrode patch on the skin of the calf and the preset treatment program of 30 minutes is started. There are three levels of intensity and the most comfortable intensity level below painful threshold must be chosen. Subjects can stop treatment any time. In case of a prolonged attack treatment can be continued. Before and after each treatment session a VAS on RLS symptoms is scored. During the four-week study subjects keep a diary. Subjects have to visit the clinic at the begin and end of the study, and fill in questionnaires related to RLS and LEX0 usability.
casper van waveren Hogervorst
0619626021
c.vanwaverenhogervorst@centrum-oosterwal.nl
casper van waveren Hogervorst
0619626021
c.vanwaverenhogervorst@centrum-oosterwal.nl
Inclusion criteria
- age >18 < 80 yrs;
- 5 essential diagnostic criteria RLS according IRLSSG;
- RLS attack ≥ once a week.
IRLSSG: International Restless Legs Syndrome Study Group
Exclusion criteria
- RLS medication
- Cardiac pacemaker, Implanted defibrillator, Transdermal drug delivery system
- Open wounds, skin eruptions or infected areas on legs
- Lack of normal sensation in legs
- Deep vein thrombosis during last 6 months
- Another sleep disorder
- Another movement disorder (e.g. Parkinson disease, dyskinesia, or dystonia)
- Epilepsy
- Pregnancy
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7672 |
| CCMO | NL68957.098.19 |
| OMON | NL-OMON48228 |