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IRCT20231217060447N1 IRCT 2024-01-22 Semnan University of Medical Sciences Study the Effect of Extracorporeal Shockwave Therapy on Iliotibial Band Thickness, Pain and lower limb function in Athletes with Iliotibial Band Friction Syndrome Study the Effect of Extracorporeal Shockwave Therapy on Iliotibial Band Thickness, Pain and lower limb function in Athletes with Iliotibial Band Friction Syndrome 2024-02-20 anticipated 42 Complete https://irct.ir/trial/74563 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples are assigned (to two groups) randomly and using the method of random permutation blocks with 6 blocks of 6, assigned to the two groups. In this method, A will represent the intervention group and B will represent the control group. In this way, the order of A and B interventions in the form of blocks from 1 to 6 is determined by the methodological consultant of the project, and is provided to the executive supervisor of the project, and the researcher obtains an assignment from the executive supervisor to assign each qualified person. The supervisor first selects the block using a random number generator (or dice roll) and then the eligible individuals are assigned to one of the two groups A or B in the order specified in the table (top to bottom). And the sequence of each item will be crossed out. It should be noted that if a block is selected based on random numbers that have already filled all 6 sequences, another random number will be selected again for that person, Blinding description: After completing the informed consent form, the participants enter the research and are placed in two groups. At this stage, the machine operator knows about the people in the treatment groups, and the participants, the researcher, do not know about the people in the studied groups to avoid bias in the study. ​. N/A Iliotibial Band Syndrome. Intervention 1: Intervention group: In the intervention group, shock wave ESM device model EMS SWISS DOLORCLAST will be performed. First, the most painful area of the external femoral condyle of the patient will be evaluated using point touch. Then RSWT with 500 pulses in mJ/mm2 (2 Bar) 0.10 with a frequency of 15 Hz will be applied in the selected area. Depending on the level of pain tolerance, it will increase up to 2000 mJ/mm2 pulse (2 Bar) 0.10 to 0.40 mJ/mm2 (4 Bar). No local anesthesia will be used. Intervention 2: Control group: All people in the control group will receive the shockwave in the same position with the device turned on but in such a way that it does not shock their body. First, a few shocks below the receiving threshold and then the device turns off. 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 further information
public Dr Atefeh Aminianfar
Semnan University of Medical Sciences , Semnan-Damghan Road 5th km
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 aminfar@semums.ac.ir Semnan University of Medical Sciences scientific Dr Atefeh Aminianfar
Semnan University of Medical Sciences and Health Services , Basij Boulevard , Semnan , Iran
semnan Iran (Islamic Republic of) 3514799442 +98 23 3344 1022 aminfar@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Age between 18_50 years Runners with experience of more than one year and regular weekly training and participation in running competitions Having pain at least 4 weeks in the lateral of the knee Pain intensity between 4_7 18 years 50 years Both Symptoms of knee injury Previous treatment of Iliotibial band syndrome within the last six months Pain intensity more than 7 Using of NSAIDs during the last two weeks Using of hot pack and ice pack Stretching or weight lifting for the previous two days History of knee surgery Pregnancy Broken Leg bones affected in the last 12 months History of treatment with Shock Wave Tumor Diabetes Rheumatic disease Severe Heart disease Psychiatric disease Unwillingness to accept any intervention in the study M76.3 Iliotibial band syndrome Treatment - Devices Treatment - Devices Intervention group: In the intervention group, shock wave ESM device model EMS SWISS DOLORCLAST will be performed. First, the most painful area of the external femoral condyle of the patient will be evaluated using point touch. Then RSWT with 500 pulses in mJ/mm2 (2 Bar) 0.10 with a frequency of 15 Hz will be applied in the selected area. Depending on the level of pain tolerance, it will increase up to 2000 mJ/mm2 pulse (2 Bar) 0.10 to 0.40 mJ/mm2 (4 Bar). No local anesthesia will be used Control group: All people in the control group will receive the shockwave in the same position with the device turned on but in such a way that it does not shock their body. First, a few shocks below the receiving threshold and then the device turns off Pain. Timepoint: Before starting the study and immediately after treatment. Method of measurement: According to Visual Analogue Scale (VAS ). Lower Limbs Function. Timepoint: Before starting the study and immediately after treatment. Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS ) Questionnaire. Iliotibial Band Thickness. Timepoint: Before starting the study and immediately after treatment. Method of measurement: Sonography. Semnan University of Medical Sciences Approved 2024-01-01 Ethics Committee of Semnan University of Medical Sciences Semnan University of Medical Sciences and Health Services, Basij Boulevard ,Semnan, Iran Semnan Semnan Iran (Islamic Republic of)