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IRCT20190903044677N2 IRCT 2022-03-25 Iranshahr University of Medical Sciences Evaluation of the effect of platelet-rich plasma in the treatment of frozen shoulder disease Comparison of the efficacy of platelet-rich plasma with corticosteroid in the Treatment of patients with frozen shoulder 2022-02-21 anticipated 75 Complete https://irct.ir/trial/61006 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with Excel RAND function will be implemented. To create a random chain of 3 groups of 25, in a column, 25 letters A, 25 letters B, ‎and 25 letters C, and in the adjacent column, 75 random numbers are made by order of RAND. The ‎composition of both columns is arranged based on the random numbers from large to small. The ‎sequence of letters A, B, and C is used‏.‏ These numbers are placed in opaque envelopes, and one envelope is assigned to each patient. Finally, the envelope is opened and the assigned treatment group is identified, Blinding description: Participating patients and injectors will be blind to the type of treatment used for each patient. To ‎blind patients, they will be told that they will receive one of three treatments: corticosteroids, ‎platelet-rich plasma, or normal saline. To blind the injector, the solution is first drawn into a syringe in ‎another room by a trained nurse and covered with a label on the syringes so that the difference of ‎liquid inside is not clear. The ready for injection syringe is then handed to the doctor for injection.‎. 3 Frozen Shoulder. Intervention 1: First intervention group (injection of platelet-rich plasma): 20 ml of blood will be taken from patients and poured into two tubes for separation of platelet-rich plasma (Noavaran Salamat Arjang Co. with a volume of 10 cc). Then, it will be centrifuged at1800 rpm for 14 minutes. 4 ml of platelet-rich plasma is extracted from each tube and a total of 8 ml of platelet-rich plasma is injected intra-articularly to the patient's shoulder within a maximum of half an hour after blood sampling. Intervention 2: Second intervention group (corticosteroid injection group): 2 ml of methylprednisolone acetate (40 mg) is combined with 2 ml of 2% lidocaine and 11 ml of normal saline and the resulting solution will be injected intra-articularly into the patient's shoulder. Intervention 3: Control group: 13 ml of normal saline in combination with 2 cc of 2% lidocaine will be injected intra-articularly into the patient's shoulder. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Start of access period from 1402 To whom: The data of this study will be available only to researchers working in academic and scientific institutions Conditions: The data will be available if the request is sent to the email of the project manager, and any kind of analysis of the data is allowed. Where to obtain: To receive the data, Dr. Pouria Tabrizian should be contacted through the following ways: Postal Address: ddressShafa Yahyaeian Hospital, In front of the gas station, Mojahedine-Islam Ave, Shohada Sq P.O BOX:1157637131‎ Telephone: 0098 21 33542041 Fax: 0098 21 33542020 Mobile: 0098 9155216214‎ Email: tabrizian.pouria@gmail.com How to obtain: After sending an email to request the documents and reviewing the request by the project executor, the applicant will refer to the introduced center with the identification documents on the specified date and receive the documents. Comments:
public Pouria Tabrizian
Shafa Yahyaeian Hospital, In front of gas station, Mojahedine-Islam Ave, Shohada Sq
Tehran Iran (Islamic Republic of) ‎1157637131‎ +98 21 3354 2041 tabrizian.pouria@gmail.com Iranshahr University of Medical Sciences scientific Pouria Tabrizian
Shafa Yahyaeian Hospital, In front of gas station, Mojahedine-Islam Ave, Shohada Sq
Tehran Iran (Islamic Republic of) ‎1157637131‎ +98 21 3354 2041 tabrizian.pouria@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of frozen shoulder disease by an orthopedist Providing informed consent to participate in the study 18 years 80 years Both History of frozen shoulder Other shoulder-related diseases include calcified tendonitis, rotator cuff arthropathy, severe osteoarthritis of the shoulder, or a history of recurrent or late shoulder dislocation History of shoulder surgery Accompanying musculoskeletal patients including severe osteoarthritis, rheumatoid arthritis, fibromyalgia, etc. Recent development of severe psychiatric disorders such as psychosis, mania, suicide and major cognitive impairment depression such as mental retardation or dementia M75.0 Periarthritis of shoulder Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group (injection of platelet-rich plasma): 20 ml of blood will be taken from patients and poured into two tubes for separation of platelet-rich plasma (Noavaran Salamat Arjang Co. with a volume of 10 cc). Then, it will be centrifuged at1800 rpm for 14 minutes. 4 ml of platelet-rich plasma is extracted from each tube and a total of 8 ml of platelet-rich plasma is injected intra-articularly to the patient's shoulder within a maximum of half an hour after blood sampling. Second intervention group (corticosteroid injection group): 2 ml of methylprednisolone acetate (40 mg) is combined with 2 ml of 2% lidocaine and 11 ml of normal saline and the resulting solution will be injected intra-articularly into the patient's shoulder. Control group: 13 ml of normal saline in combination with 2 cc of 2% lidocaine will be injected intra-articularly into the patient's shoulder. Shoulder pain. Timepoint: Before the start of intervention and weeks 3, 6 and 12 after the intervention. Method of measurement: Visual Analogue Scale. Shoulder function. Timepoint: Before the intervention and weeks 3, 6 and 12 after the intervention. Method of measurement: Disabilities of the arm, shoulder and hand Questionaire. Iranshahr University of Medical Sciences Approved 2020-12-13 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Next to Milad Tower, Hemat Highway Tehran Tehran Iran (Islamic Republic of)