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IRCT20221029056333N3 IRCT 2023-04-28 Babol University of Medical Sciences Effect of ultrasound guided intra-articular injection of corticosteroids and platelet-riched plasma in the treatment of rotator cuff tendinopathy Comparison of the effect of ultrasound guided intra-articular injection of corticosteroids and platelet-riched plasma in the treatment of rotator cuff tendinopathy 2023-04-10 anticipated 60 Complete https://irct.ir/trial/69731 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People included in the study will be randomized by simple random method. Tables of random numbers found in many statistical reference books will be used to randomize the numbers. Numbers between 0 and 24 are assigned to the first group, numbers between 25 and 49 are assigned to the second group. The study group includes Cortone and PRP. Concealment is done in consecutively numbered, sealed, opaque envelopes and is kept by the department secretary, Blinding description: This study is a double-blind clinical trial in which the participant, the outcome assessor and the data analyst will be unaware of the treatment process. After randomization, the patients of each treatment group are introduced by researcher 1 (one of the executive residents) to researcher 2 to evaluate the outcome. Researcher 2 (one of the supervisors) is only an outcome assessor and records the results without knowing the type of treatment and its effects. A person who is an information analyst (statistician) also receives the recorded information at the end of the work and is not in the process of the intervention groups in any way. Patients also do not know about the injectable substance. Blood is taken from all patients. Plasma in two intervention groups is drawn in a covered syringe. 3 Rotator cuff tendinopathy. Intervention 1: Intervention group: For this group, PRP injection is performed. In this method, the patient had one PRP injection. In this group, 35 cc of venous blood was taken along with 5 cc of EDTA (Ethylenediaminetetra-acetic acid) and divided equally into 4 tubes. And by Royagen centrifuge machine, the first round is done for 10 minutes at a speed of 1600 rpm and then the obtained plasma enters two tubes and the second round will be done at a speed of 3500 rpm for 6 minutes. In this case, 6 cc of liquid containing platelets with 5 to 6 times concentration will be obtained. The samples will be sent to the laboratory before and after centrifugation to prove platelet concentration. Then, 6 cc of the obtained liquid is divided into two syringes with 3 cc each. 3 cc of that injection is performed by a resident project manager intra-articularly with an angle of 30-45 degrees from posterolateral. Intervention 2: Control group: This group receives corticosteroid injection in the form of methylprednisolone (depomedrol) 40 mg intra-articularly. No - There is not a plan to make this available Justification or reason for not sharing IPD is .
public Dr. Mehrdad Mostafalo
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
Babol Iran (Islamic Republic of) 4716681451 +98 11 3225 6285 mostafa_mehrdad@yahoo.com Babol University of Medical Sciences scientific Dr. Mehdi Tavasoli
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
Babol Iran (Islamic Republic of) 4716681451 +98 11 3225 6285 Mehdi.tavasolii@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Shoulder pain that lasts more than three months Tendinopathy and partial rupture of rotator cuff tendons MRI findings of tendinopathy or incomplete rotator cuff tear 40 years 60 years Both Complete rupture of rotator cuff tendons History of shoulder surgery in the last 6 months Presence of rheumatological inflammatory diseases Shoulder instability is based on examinations The history of corticosteroid injection in the shoulder joint in the last 3 months History of PRP treatment in the last 6 months Dissatisfaction of patients M75.1 Rotator cuff tear or rupture, not specified as traumatic Treatment - Drugs Treatment - Drugs Intervention group: For this group, PRP injection is performed. In this method, the patient had one PRP injection. In this group, 35 cc of venous blood was taken along with 5 cc of EDTA (Ethylenediaminetetra-acetic acid) and divided equally into 4 tubes. And by Royagen centrifuge machine, the first round is done for 10 minutes at a speed of 1600 rpm and then the obtained plasma enters two tubes and the second round will be done at a speed of 3500 rpm for 6 minutes. In this case, 6 cc of liquid containing platelets with 5 to 6 times concentration will be obtained. The samples will be sent to the laboratory before and after centrifugation to prove platelet concentration. Then, 6 cc of the obtained liquid is divided into two syringes with 3 cc each. 3 cc of that injection is performed by a resident project manager intra-articularly with an angle of 30-45 degrees from posterolateral. Control group: This group receives corticosteroid injection in the form of methylprednisolone (depomedrol) 40 mg intra-articularly. Pain. Timepoint: Before treatment and 1, 2, 3, and 6 months after the start of treatment. Method of measurement: Using the VAS scale & record severe pain intensity. Shoulder range of motion. Timepoint: Before treatment and 1, 2, 3, and 6 months after the start of treatment. Method of measurement: By goniometer. Patients' performance. Timepoint: Before treatment and 1, 2, 3, and 6 months after the start of treatment. Method of measurement: Disabilities of the Arm, Shoulder and Hand Outcome یا DASH. Babol University of Medical Sciences Approved 2023-03-12 Health Research Institute - Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)