The effect of local vibration on restless legs syndrome

Phase 2

Recruiting

Conditions: Restless leg syndrome.
Restless legs syndrome
G25.81

Registration Number: IRCT20190306042945N4

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

Age 18 to 60 years
Having symptoms for at least 15 days during the 30 days leading up to the start of the intervention
Satisfaction with the completion of the project
Having 4 criterias
Patients with at least moderate symptoms
Stop taking any medication for the treatment of restless leg syndrome at least two weeks before

Exclusion Criteria

Pregnancy or breastfeeding
Reluctance to treat local vibration
The presence of a pacemaker or ICD
Existence of active malignancy
Existence of fracture, open wound, abscess, cellulitis or infection at the place of vibration
CKD (GFR<60)
Iron deficiency anemia (ferritin less than 20)
Vitamin deficiency (Vit D level < 30)
Deep vein thrombosis (DVT)
Evidence of radicular pain, radiculopathy or neuropathy (clinical or paraclinical evidence)
Background diseases such as diabetes, thyroid diseases, Parkinson's, rheumatological diseases and...
The history of the company in research projects for the treatment of restless legs syndrome at least during the last month.
History of drug or alcohol abuse
Psychological disorders (such as depression, anxiety disorder, etc.) or any cognitive disorder
Movement disorders (tremor, dystonia, etc.)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of symptoms and restlessness of the legs. Timepoint: Before the beginning, after the last session and one month after the end of the intervention. Method of measurement: International Restless Leg Syndrome Study Group Rating Scale (IRLSRS).

Secondary Outcome Measures

Name	Time	Method
Sleep quality. Timepoint: Before the beginning, after the last session and one month after the end of the intervention. Method of measurement: Standardized questionnaire Pittsburg in Farsi.