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IRCT20191217045764N2 IRCT 2021-02-01 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 2020-02-24 anticipated 30 Complete https://irct.ir/trial/53150 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Permissive blocks will be used for random allocation of patients. So we have 5 blocks with two repetitions in each block (BABA, BAAB, ABAB, AABB, ABBA) and we selected 10 numbers from the table of random numbers, so that if the numbers 1 and 0 were selected, the first block, the number 3 and 2, the second block, the number 5 and 4, the third block, 6 and 7 Blocks , the forth block, 8 and 9, the fifth block, were selected and the final allocation of samples was calculated from the sequence of these blocks, 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: Intervention group: In this study, the transcutaneous electrical nerve stimulation (TENS) electric current is used at a frequency of 100 Hz, three times in three consecutive days, 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 Ali Abedi
No. 70, Imam Reza Alley12, Imam Reza Ave
Esfarayen Iran (Islamic Republic of) 9613873136 05144011300-6 mtadayonfar@yahoo.com Esfarayen University of Medical Sciences scientific Ali Abedi
No.70, Imam Reza Alley12 , Imam Reza Ave
Esfarayen 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 in the final step, score higher than 4 based on the standard questionnaire 35 years no limit Both History of neurological disease other than Restless Legs Syndrome Presence of vascular diseases other than restless legs syndrome according to the doctor's opinion 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, ...) Intensification 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 Intervention group: In this study, the transcutaneous electrical nerve stimulation (TENS) electric current is used at a frequency of 100 Hz, three times in three consecutive days, 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: Before the start of the first stage intervention, before the start of the second stage intervention, before the start of the third stage intervention, the day after the third stage 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)