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IRCT20160422027520N17 IRCT 2020-04-14 Tabriz University of Medical Sciences Treatment of cuff tendinopathy with platelet lysis The effects of platelet lysate therapy on cuff tendinopathy 2020-05-19 anticipated 40 Complete https://irct.ir/trial/46947 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Cuff tendinopathy. Intervention 1: Intervention group: In this group of patients, 10 ml of blood will be taken by PRP-specific syringe manufactured by Noavaran Salamat Arjang CO. and according to kit protocol, we will separate the PRP and then produce Platelet lysate. The Platelet lysate will then be injected by a physician into the cuff tendon of the patient with cuff tendinopathy. The Platelet lysate injection volume will be 2 cc.The injection will be repeated with a 21 days apart. Intervention 2: Control group: No drugs will be injected into patients in this group. 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 No more information
public Mehdi Yousefi
Department of Immunology, Tabriz University of Medical Sciences,
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 1336 4665 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mehdi Yousefi
Department of Immunology, Tabriz University of Medical Sciences,
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 1336 4665 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Men and women between the ages of 18 and 75 with cuff tendinopathy The availability of individual during the study period 18 years 75 years Both People under the age of 18 and over 75 years Pregnant women or women who are breastfeeding People with malignancy,People with severe heart disease, uncontrolled diabetes mellitus, hemorrhagic diseases, history of anemia, arthritis, fibromyalgia and chronic fatigue syndrome Those linked to acetaminophen or Vicodin or a history of drug misuse History of cortisone injections in the last 6 weeks The use of non-steroidal anti-inflammatory drugs 1 week ago Having hemoglobin less than 11 g / dl and platelet count less than 150000 / mμ The use of inhibitors of platelet aggregation and anti-coagulation such as heparin History of cuff surgery in the last 3 months M75.101 Unspecified rotator cuff tear or rupture of right shoulder, not specified as traumatic Treatment - Drugs Treatment - Drugs Intervention group: In this group of patients, 10 ml of blood will be taken by PRP-specific syringe manufactured by Noavaran Salamat Arjang CO. and according to kit protocol, we will separate the PRP and then produce Platelet lysate. The Platelet lysate will then be injected by a physician into the cuff tendon of the patient with cuff tendinopathy. The Platelet lysate injection volume will be 2 cc.The injection will be repeated with a 21 days apart. Control group: No drugs will be injected into patients in this group Determining cuff pain by VAS in all phases of clinical trial. Timepoint: 1 and 3 months after the first injection. Method of measurement: Questionnaire (VAS). Determination of cuff function by Shoulder Pain and Disability Index (SPADI) in all phases of clinical trial. Timepoint: 1 and 3 months after the first injection. Method of measurement: Questionnaire (SPADI). Determine the range of cuff motion by manual joiniometry in all phases of clinical trial. Timepoint: 1 and 3 months after the first injection. Method of measurement: Range of motion (Degree). Tabriz University of Medical Sciences Approved 2020-01-20 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences , Daneshghah st, Tabriz, Tabriz East Azarbaijan Iran (Islamic Republic of)