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IRCT20191217045764N1 IRCT 2020-01-01 Esfarayen University of Medical Sciences The effect of Transcutaneous Electrical Nerve (TENS) on the restless leg syndrome (RLS) The effect of Transcutaneous Electrical Nerve (TENS) on the restless leg syndrome (RLS) In patients with this complaint 2020-02-18 anticipated 80 Complete https://irct.ir/trial/44369 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Permissive blocks will be used for random allocation of patients, Blinding description: Patients will be unaware of being in the control and intervention groups. In order to not exchange information between the patients in the two groups; patients will be considered for interview and training in the separate room. Patients are reminded to not exchange information with other patients during the study. 3 Restless Legs Syndrome. Intervention 1: In this study, the TENS electric current is used at a frequency of 100 Hz, twice a week (Twice in total), and each time an intervention, for 20 minutes. Due to the location of the complication, the electrodes are attached to the extremities (legs). The efficacy of TENS is evaluated according to the patient's condition. In the intervention group, the TENS device with HZ100 frequency will be used. Intervention 2: Control group: in this group placebo TENS will be used. The leads connect to the lower extremities, but the device is off. No - There is not a plan to make this available Justification or reason for not sharing IPD is The required data will appear in the article.
public Moosa Reza Tadayonfar
Tohid Shahr Blvd, University Campus Building, Departmment of Education, Sabzevar
Sabzevar Iran (Islamic Republic of) 9613873136 05144011300-6 mtadayonfar@yahoo.com Sabzevar University of Medical Sciences scientific Ali Abedi
No.70, Imam Reza Alley12 , Imam Reza Ave
Sabzevar Iran (Islamic Republic of) 9661876981 +98 58 3155 0000 Abedia1371@gmail.com Esfarayen University of Medical Sciences Iran (Islamic Republic of) People over 35 years old Restless leg syndrome based on patient self-report Restless leg syndrome based on a doctor's diagnosis And in the final step, score higher than 4 based on the standard questionnaire 35 days no limit Both There is a history of psychiatric illness except restless leg syndrome Vascular diseases except restless leg syndrome according to physician Neuromuscular Disorders (Technique Problem) Experience the crisis over the past 3 months Patient's unwillingness to cooperate in design Severe stress to the individual or family over the past two weeks(death of a family member, ...) Intensify of RLS Use of antispasmodics over the past two weeks Use of anticonvulsants in the past two weeks Use of antidepressants over the past two weeks Use of sedatives over the past two weeks Using herbal remedies or any non-pharmacological treatments for treating restless legs syndrome over the past two weeks G25.81 Restless legs syndrome Treatment - Devices Placebo In this study, the TENS electric current is used at a frequency of 100 Hz, twice a week (Twice in total), and each time an intervention, for 20 minutes. Due to the location of the complication, the electrodes are attached to the extremities (legs). The efficacy of TENS is evaluated according to the patient's condition. In the intervention group, the TENS device with HZ100 frequency will be used. Control group: in this group placebo TENS will be used. The leads connect to the lower extremities, but the device is off. Severity of restless leg syndrome. Timepoint: At the beginning of the study (before the intervention). Immediately after intervention on two occasions, twice a week (Twice in total), in each time an intervention. Method of measurement: Using the International Restless Legs Syndrome Study Group (IRLSS) questionnaire. Esfarayen University of Medical Sciences Approved 2019-12-17 Ethics Committee of Esfarayen University of Medical Sciences No. 70, Imam Reza Alley12 , Imam Reza Ave Esfarayen North Khorasan Iran (Islamic Republic of)