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IRCT201302174251N9 IRCT 2013-05-03 Iran University of Medical Sciences Comparing the effect of corticosteroid injections and platelet rich plasma on the treatment of shoulder tendinopathy PRP Comparative study of corticosteroid injections and platelet rich plasma in the treatment of patients with shoulder tendinopathy compare sonographic findings 2013-04-21 anticipated 56 Complete https://irct.ir/trial/4514 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups based on random number table after confirming the diagnosis with MRI and referring to the sports medicine department, Blinding description: The platelet rich plasma group is injected one time. In this group, 35 ml of venous blood was taken and by the Selex centrifuge under the RCF protocol, the blood sample is separated from rich plasma platelet by 1700 and 3200 rpm. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. The injection is performed by a sports medicine specialist in the form of intraarticular with an angle of 30-45 degrees from the posterolateral. And if there is a partial rupture in tendon, 3 cc PRP injection is performed under ultrasound guidance at the tendon rupture site. One week after the injection, the patient is visited, examined, given the necessary advice and also exercise prescription. Exercise is divided to scapula rehabilitation and shoulder muscles training. After one and three months, repeated examinations, including pain, function, Completion of WORC, DASH questionnaire and ultrasound changes was achieved , and a comparison between the patient's clinical and Para clinical symptoms within these periods was performed. The injection for corticosteroid group, however, is applied Methylprednisolone 40 mg once. For patients, one cc of Depomedrol and one cc of 2% lidocaine solution are injected into the intra articular joint in the same PRP manner. In this group, due to the blindness of the study, blood sampling of the patient is performed before corticosteroid injection. N/A Shoulder Tendinopathy. Intervention 1: The platelet rich plasma group is injected twice within a month. In this group, 20 ml of venous blood was taken by centrifuges Selex protocol RCF, blood samples from the men with the 1800 and 2000 cycles and women with 1600 and 2000 cycle. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. Under ultrasound Guide, in collaboration with a radiologist and a sports medicine specialist in the area of sub-45 degree lateral Acromion is injected (based on Sonographic Guide). Assessment of clinical sing such as pain (based on VAS measurement), shoulder range of motion and its function is occurred. Moreover, musculoskeletal sonography is applied by two clinician experts. These (findings are) recorded and compared. Intervention 2: The injection for corticosteroid group, however, is applied MethylPrednisolone 40 mg once or twice within a month based on the Rheumatologist decision. At the baseline, after four weeks and also eight weeks after intervention, all the studies including pain, range of motion, function, and Sonographic findings changes are evaluated and compared with the data which is recorded before intervention. Yes - There is a plan to make this available What will be shared: After deidentifing participants, sharing data related to pain, ROM, function and thickness of tendon will be happened When: starting 6 months after publication To whom: Researchers and people working in Academic institution Conditions: To applied in research or manuscript Where to obtain: Personal email, Mobile phone , research gate How to obtain: 3 months after applying, the document will send through email Comments:
public Haleh Dadgostar MD
Shahr Ara street Sattar khan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2446 hldadgostar@gmail.com sports medicine department Rasoul e Akram hospital scientific Haleh Dadgostar MD
Shahr Ara street Sattar khan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2446 hldadgostar@gmail.com Sports Medicine Research Center Tehran University of Medical Sciences Tehran Iran Iran (Islamic Republic of) Iran (Islamic Republic of) Shoulder pain that lasts for more than 3 months limited shoulder range of motion Absence of radicular pain Inflammatory disorders such as rheumatoid arthritis Fibromyalgia lack of complete rotator cuff tear The ligament laxity Non-corticosteroid injections in the past three months 40 years no limit Both Unwillingness of the patient to continue treatment shoulder joint surgery The presence of other disorders that limit joint motion such as frozen shoulder M75.1 rotator cuff syndrome rotator cuff or supraspinatous tear or rupture (complete ) ( incomplete ) not specified as traumatic Treatment - Drugs Treatment - Drugs The platelet rich plasma group is injected twice within a month. In this group, 20 ml of venous blood was taken by centrifuges Selex protocol RCF, blood samples from the men with the 1800 and 2000 cycles and women with 1600 and 2000 cycle. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. Under ultrasound Guide, in collaboration with a radiologist and a sports medicine specialist in the area of sub-45 degree lateral Acromion is injected (based on Sonographic Guide). Assessment of clinical sing such as pain (based on VAS measurement), shoulder range of motion and its function is occurred. Moreover, musculoskeletal sonography is applied by two clinician experts. These (findings are) recorded and compared The injection for corticosteroid group, however, is applied MethylPrednisolone 40 mg once or twice within a month based on the Rheumatologist decision. At the baseline, after four weeks and also eight weeks after intervention, all the studies including pain, range of motion, function, and Sonographic findings changes are evaluated and compared with the data which is recorded before intervention Pain. Timepoint: every 2 weeks up to 8 weeks. Method of measurement: VAS scale. Range of motion. Timepoint: every 2 weeks up to 3 months. Method of measurement: Goniameter. Sonographic finding. Timepoint: at base line and 3 months later. Method of measurement: Sonographic prob. Iran University of Medical Sciences Approved 2012-07-20 Tehran University of Medical Sciences Ghods street Keshavars Blv Tehran Tehran Iran (Islamic Republic of)