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IRCT20190306042945N4 IRCT 2023-08-30 Iran University of Medical Sciences The effect of local vibration on restless legs syndrome The effect of local vibration on restless legs syndrome 2023-09-23 anticipated 36 Complete https://irct.ir/trial/71705 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are randomly divided into two groups for local vibration intervention (first group) and gabapentin treatment (second group). The randomization method is done in the form of restricted randomization and random allocation rule. In this method, numbers 1 and 2 (representative of the first and second groups) are written on papers of the same size and design and placed inside the envelope. And after moving the envelopes, the sufferers are asked to choose one of them randomly, Blinding description: Blinding method: After collecting the data, their analysis is done by another person (other than the main researcher) who does not know how to group the data. 2 Restless leg syndrome. 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 range of 80-120 Hz for 35 minutes every night before going to bed. On the calf muscles and also during attacks of restlessness and unpleasant feelings for a period of one month. Intervention 2: Intervention group: under treatment with 300 mg gabapentin daily (at night one hour before sleep) for one month. Yes - There is a plan to make this available What will be shared: Individual data: All data can be shared after de-identifying individuals. Study protocol: The entire protocol can be shared after de-identifying people. Statistical analysis map: The whole map can be shared after de-identifying people. Informed Consent Form: Can be shared after de-identifying individuals. Clinical Study Report: The entire report can be shared after de-identifying individuals. Codes used in the analysis: All codes can be shared after de-identifying people. Data classification system: It can be shared after de-identifying people. When: The access period starts from 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: In case of research on a similar topic, he/she can use the data of this research. Where to obtain: 1- Email: hamida2091@gmail.com 2- Postal address: Firouzgar Hospital, Beh Afarin St., Valiasr Square, Tehran How to obtain: After correspondence via e-mail or postal address, it is possible to receive data and documents within a period of two months at the discretion of the researcher. Comments:
public Hamid Ansari
Firouzgar Hospital, Beh Afarin St., Valiasr Square
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ +98 21 8214 1000 Hamida2091@gmail.com Iran University of Medical Sciences scientific Bijan Forogh
Firouzgar Hospital, Beh Afarin St., Valiasr Square
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ +98 21 8214 1000 Forogh.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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.) G25.81 Restless legs syndrome Treatment - Devices Treatment - Drugs 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 range of 80-120 Hz for 35 minutes every night before going to bed. On the calf muscles and also during attacks of restlessness and unpleasant feelings for a period of one month. Intervention group: under treatment with 300 mg gabapentin daily (at night one hour before sleep) for one month. 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). 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. Iran University of Medical Sciences Approved 2022-10-29 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Iran University of Medical Sciences, Central Headquarters Building, Research and Technology Vice-Chancellor, next to Milad tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)