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The effect of local vibration on restless legs syndrome

The effect of local vibration on restless legs syndrome

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190306042945N4
Enrollment
36
Registered
2023-08-30
Start date
2023-09-23
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless leg syndrome. Restless legs syndrome

Interventions

Intervention 1: Intervention group: under treatment with local vibration with a vibrator device with the trade name VBA (which is delivered to them) with low voltage (3 volts) and frequency in the ran

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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.)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Ansari

Iran University of Medical Sciences

Hamida2091@gmail.com+98 21 8214 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jul 29, 2026