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IRCT20210210050317N1 IRCT 2021-04-01 Tehran University of Medical Sciences the effect of Blood Flow Restriction Exercises on tendinopathy BFR : Effects of Blood Flow Restriction Exercises on Strength and Thickness of Supraspinatus Muscle and Level of Shoulder Pain at the Patients with Sub Acute Tendinopathy 2021-01-27 anticipated 30 Complete https://irct.ir/trial/54353 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using the envelope method in such a way that 30 envelopes are prepared and 15 numbers 1 (control group) and 15 numbers 2 (intervention group) are written on paper and placed inside the envelopes, after the sequence of envelopes is mixed, to select an envelope, all the envelopes are placed on the table to select them. After selecting the patient, the desired envelope is separated from the envelopes. This method is repeated for all patients. For the last patient, due to the fact that one envelope remains and according to the effect of the choice of others on the number of this envelope, a random state is maintained, Blinding description: for blinding the researcher we will use another therapist for treatment in control and intervention group . patient blinding also will be doing with BFR cuff with minimal pressure. 3 Sub-acute Supraspinatus Tendinopathy. Intervention 1: Intervention group: Using low load exercises with blood flow restriction device using strength training protocol in such a way that in the upper limb 50% of the pressure that causes the pulse to be cut is used and in the lower limb 80% of this pressure is used. The sports version is in 4 sets with 30 repetitions in the first set and 15 times in the other three sets. Exercises with low load (15-40% of the maximum weight that a person can lift once). The device used is the standard model of the blood flow restriction device, which has vascular Doppler, which has the Smart Tools brand from the United States. Intervention 2: Control group: Exercises with low load using the cuff of the same device with minimal pressure to prevent the effects of placebo. The number of repetitions and sets as well as the amount of exercise load is similar to the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no additional information
public Zahra Poursaleh Begi
No. 8, Block 14, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran
Tehran Iran (Islamic Republic of) 1955743494 +98 21 2244 6831 poursalehzahra@gmail.com Tehran University of Medical Sciences scientific Zahra Poursaleh Begi
No. 8, Block 1, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran
Tehran Iran (Islamic Republic of) 1955743494 +98 21 2244 6831 poursalehzahra@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) male and female with age limit 30-65 years old that have shoulder pain at least 1,5 month ago and at most 3 month ago the patient should have at least Positive 2 tests of these test: Painful Arch, Full Can, Empty Can and Hawkins patient that refer from orthopedic Doctors with sign and symptom of supraspinatus thendinopathy or if the patient have any evidence for tendinopathy with ultrasound and MRI 30 years 65 years Both All contraindications of BFR( Blood Flow Restriction) , including history of blood clots, hypertension above 100/180, acute infection, peripheral vascular problems and varicose veins, cancer, Hemorrhagic or Thrombotic stroke, history of DVT( Deep Veins Thrombosis), Arterial fibrillation. Body Mass Index over 30 People taking medication for high blood pressure and blood sugar. People with a history of surgery, fractures or osteoarthritis in the shoulder area People who are suspected of having symptoms of COVID 19, such as fever, cough, runny nose, etc. M75.80 Other shoulder lesions, unspecified shoulder Rehabilitation Rehabilitation Intervention group: Using low load exercises with blood flow restriction device using strength training protocol in such a way that in the upper limb 50% of the pressure that causes the pulse to be cut is used and in the lower limb 80% of this pressure is used. The sports version is in 4 sets with 30 repetitions in the first set and 15 times in the other three sets. Exercises with low load (15-40% of the maximum weight that a person can lift once). The device used is the standard model of the blood flow restriction device, which has vascular Doppler, which has the Smart Tools brand from the United States. Control group: Exercises with low load using the cuff of the same device with minimal pressure to prevent the effects of placebo. The number of repetitions and sets as well as the amount of exercise load is similar to the intervention group. Supraspinatus strength. Timepoint: measurement of supraspinatus strength will do in first session and after 12 session ( 4 month later ,tree time a week). Method of measurement: the approach of measurement the strength is using fixed Dynamometer. Serratus - Anterior Strength. Timepoint: measurement of serratus anterior strength will do in first session and after 12 session ( 4 month later ,tree time a week). Method of measurement: the approach of measurement the strength is using fixed Dynamometer. Middle and lower trapezius strength. Timepoint: measurement of Strength of Middle and Lower Trapezius Muscle will do in first session and after 12 session ( 4 month later ,tree time a week). Method of measurement: the approach of measurement the strength is using fixed Dynamometer. Supraspinatus Strength. Timepoint: measurment of supraspinatus thickness will do in first session and after 12 session ( 4 month later ,tree time a week). Method of measurement: the approach of measurement the thickness is using Ultrasound devise. Pain Pressure Threshould. Timepoint: measurement of pain pressure threshold will do in first session and after 12 session ( 4 month later ,tree time a week). Method of measurement: the approach of measurement the Pain Pressure Threshold is using Algometer. Pain Report in every session based on Pain Numeric Scale Approach. Timepoint: measurement the amount of pain will do at before and after of every session. Method of measurement: the approach of measurement the Pain is using Pain Numeric Scale. Tehran University of Medical Sciences Approved 2021-01-23 Ethics committee of Tehran University of Medical Sciences No. 8, Block 14, Entrance One, Nasr Alley, Nasr St , Shahid Mahallati Town , Aghdasiyeh Ave, Tehran Tehran Tehran Iran (Islamic Republic of)