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IRCT20180416039324N3 IRCT 2021-09-02 Artesh University of Medical Sciences Comparison of tDCS and Sham tDCS in reducing pain and improving patient symptoms with shoulder tendinopathy referred to Imam Reza Hospital Comparison of tDCS and Sham tDCS in reducing pain and improving patient symptoms with shoulder tendinopathy 2021-08-11 anticipated 40 Complete https://irct.ir/trial/55478 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to tDCS or Sham by block randomization in one of two groups. To randomly assign two groups with 20 participants in each group (40 patients in total), we use block randomization with different block sizes. The size of the blocks is a multiple of 2 and a divisor of 40 (2,4,8). Initially, the size of the blocks is randomly selected. Then for each block, different permutations are determined for the size of the equal group. Finally, one of the permutations is randomly selected. Random numbers are generated using a computer in an independent statistical unit, Blinding description: The tDCS electrodes are placed at the predefined locations for the two groups in a similar manner for 20 minutes. In the tDCS group the active current time will be 20 minutes and in the SHAM group, it will be 30 seconds. Evaluators will also be unaware of the group allocations. N/A shoulder tendinopathy. Intervention 1: Intervention group: The treatment is in 5 sessions using a 35 cm square electrode with a current of 2 miliAmp. During this intervention, the anode electrode is placed on the primary motor cortex on the opposite side of the most painful side and the cathode is placed on the opposite super-orbital side, which of course has a protective sponge and the width of the sponges is 16 square centimeters on the skin. The patient is placed and electrode contact is made with the patient. In the tDCS group, the excitation rate reaches 2.5 miliAmp from zero in the first 10 seconds, and this excitation lasts for 20 minutes and then reaches zero in 10 seconds. Intervention 2: Control group: In the control group, in the initial 10 seconds, the excitation rate reaches 2.5mA from zero, and this excitation continues for 30 seconds, and then reaches zero in 10 seconds. The duration of use of tDCS will be 20 minutes and the duration of use will be only 30 seconds. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Leyla Yarmohammadi
Imam Reza hospital, Etemad zade street, Fatemi street
tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 Smt.1368@gmail.com Artesh University of Medical Sciences scientific Leyla Yarmohammadi
Imam Reza hospital, Etemad zade street, Fatemi street
tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 Smt.1368@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Adult patients aged 20-65 years Pain at least 6 weeks MRI-confirmed shoulder tendonitis 20 years 65 years Both Pregnancy and lactation Complete rotator cuff rupture History of tumor and malignancy Active infection in the shoulder joint or surrounding tissues Coagulation disorders and using anticoagulant drugs cervical radiculopathy Systemic rheumatic disorders Contraindications to tDCS such as metal or electronic implants, pacemakers, pregnancy and history of epilepsy S46.0 Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder Treatment - Devices Placebo Intervention group: The treatment is in 5 sessions using a 35 cm square electrode with a current of 2 miliAmp. During this intervention, the anode electrode is placed on the primary motor cortex on the opposite side of the most painful side and the cathode is placed on the opposite super-orbital side, which of course has a protective sponge and the width of the sponges is 16 square centimeters on the skin. The patient is placed and electrode contact is made with the patient. In the tDCS group, the excitation rate reaches 2.5 miliAmp from zero in the first 10 seconds, and this excitation lasts for 20 minutes and then reaches zero in 10 seconds. Control group: In the control group, in the initial 10 seconds, the excitation rate reaches 2.5mA from zero, and this excitation continues for 30 seconds, and then reaches zero in 10 seconds. The duration of use of tDCS will be 20 minutes and the duration of use will be only 30 seconds. Visual analogue scale. Timepoint: before intervention, 1 month after intervention, 3 months after intervention. Method of measurement: A 10-point VAS scale that the patient should give a score from 0 to 10. The Disabilities of the Arm, Shoulder and Hand (DASH). Timepoint: before intervention, 1 month after intervention, 3 months after intervention. Method of measurement: DASH Questionnaire with 21 questions. World health organization quality of life questionnaire (WHOQOL-BREF). Timepoint: before intervention, 1 month after intervention, 3 months after intervention. Method of measurement: world health organization quality of life (WHOQOL-BREF) with 30 items. Artesh University of Medical Sciences Approved 2020-12-19 Ethics Committees of AJA University of Medical Sciences Imam Reza hospital, Etemad zade street, Fatemi street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)