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IRCT20220803055610N1 IRCT 2022-12-22 Tehran University of Medical Sciences PRP in tendonitis Evaluation of the effect of platelet-rich plasma in the treatment of shoulder tendonitis 2023-01-19 anticipated 200 Complete https://irct.ir/trial/66563 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple random allocation method is that from the beginning, the intervention group (platelet-rich plasma) will be given odd numbers and the control group (Corton) will be given even numbers. Then, according to the number of the studied sample, the corresponding numbers are extracted using the computer, each number is written on a card and placed in an envelope, the envelopes are sealed, and the patient's name is written on each envelope. An envelope is given in order of numbers. In order to maintain randomization, the person who prepares the envelopes is different from the person who registers the patients and provides the envelopes to the patients. Registration of patients and their allocation in each of the groups is done by someone other than the doctor, Blinding description: For one group, PRP injection was performed, and in this method, the patient had one PRP injection. In this group, 20 cc of venous blood was takenIn this case, 3 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, with another syringe, the remaining 3 cc is injected under ultrasound guidance at the tendon tear site. In the other group, corten injection is done intra-articularly. In order to blind the patients, a blood sample is taken from this group before the injection, and in order to maintain medical ethics, the blood sample is sent to the laboratory to count the blood cells. Also, when injecting, adhesive tape is used around the syringe so that the patient does not notice the injected substance. 3 shoulder tendonitis. Intervention 1: After confirming the diagnosis and referring to the orthopedic department, the patients are randomly divided into two groups. For one group, PRP injection was performed, and in this method, the patient was injected with PRP once every one month, and the changes made during this period were measured up to one year after the end of the injection. In people of this group, 20 cc of venous blood is taken and by Selex centrifuge machine under RCF protocol, the blood sample is separated from platelet-rich plasma in patients and injected by sono guide.After 8 weeks, all investigations, including the amount of pain, function and ultrasound changes, are repeated and a comparison is made between the clinical and paraclinical symptoms of the patient before and after the intervention. Intervention 2: The second group receives corticosteroid injection in the form of methylprednisolone 40 mg once according to the diagnosis of the orthopedic specialist. After 8 weeks, all investigations, including the amount of pain, function, and ultrasound changes, are repeated and a comparison is made between the clinical and paraclinical symptoms of the patient before and after the intervention. Yes - There is a plan to make this available What will be shared: Data will be shared after de-identifying individuals on pain, range of motion, shoulder function, and tendon thickness. When: 6 months after the results are published To whom: For researchers and workers in academic centers Conditions: For use in research or essays Where to obtain: by e-mail or mobile and request on the research gate website How to obtain: It will be sent to the applicant by email 3 months after the request Comments:
public Nima Bagheri
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1690 mahdieh.ghiasi@yahoo.com Tehran University of Medical Sciences scientific Nima Bagheri
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1690 nimab1360@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Pain is the most common symptom. Physical examination findings include pain on movement, weakness and positive tests Diagnosis of rotator cuff tendinopathy with musculoskeletal ultrasound Symptoms have been persistent for more than 3 months and conservative treatment has failed for at least 4 weeks of formal medical treatment and physical therapy. 30 years 60 years Both Full-thickness rotator cuff tear Current treatment with anticoagulation Steroid injection in the past 6 months in the injuredshoulder Prior PRP treatment to the injured shoulder Bleeding disorders or preoperative platelet countless than 50,000 Presence of another disease that may causeshoulder pain and dysfunction as rheumatoidarthritis Prior surgery to the injured shoulder M75.1 Rotator cuff tear or rupture, not specified as traumatic Treatment - Drugs Treatment - Drugs After confirming the diagnosis and referring to the orthopedic department, the patients are randomly divided into two groups. For one group, PRP injection was performed, and in this method, the patient was injected with PRP once every one month, and the changes made during this period were measured up to one year after the end of the injection. In people of this group, 20 cc of venous blood is taken and by Selex centrifuge machine under RCF protocol, the blood sample is separated from platelet-rich plasma in patients and injected by sono guide.After 8 weeks, all investigations, including the amount of pain, function and ultrasound changes, are repeated and a comparison is made between the clinical and paraclinical symptoms of the patient before and after the intervention. The second group receives corticosteroid injection in the form of methylprednisolone 40 mg once according to the diagnosis of the orthopedic specialist. After 8 weeks, all investigations, including the amount of pain, function, and ultrasound changes, are repeated and a comparison is made between the clinical and paraclinical symptoms of the patient before and after the intervention. Pain. Timepoint: Every 2 weeks to eight weeks. Method of measurement: VAS score. Range of motion. Timepoint: Every two weeks to three months. Method of measurement: Goniometer. Ultrasound Findings. Timepoint: At the beginning of the study and after 3 months. Method of measurement: Ultrasound probe. Tehran University of Medical Sciences Approved 2022-10-30 Ethics committee of Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran,Tehran Medical sciences, Tehran Tehran Iran (Islamic Republic of)