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IRCT20151017024572N21 IRCT 2020-01-09 Iran University of Medical Sciences Effect of Mesenchimal Stem Cell in Rotator Cuff Tendinopathy Comparison of Ultrasound-Guided Local Corticosteroid Injection versus Mesenchymal Stem Cell Origin of Adipocytes ( Allogeneic ) in patient with Rotator Cuff Tendinopathy 2020-01-21 anticipated 30 Complete https://irct.ir/trial/44349 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Block randomization, Randomization description: Method of randomization: block, Unit of randomization: individual, Tools used in randomization: table of random numbers, Blinding description: This is a double-blind study in which patients and outcomes analyzer are blinded. In order to blind the patient, it is said that both materials are effective for treatment, but the type of substance is not mentioned for patients when its injected. In order to blind the analyzer, the persons responsible for injection and data collection are different from the outcome assessors. 2-3 Shoulder tendinopathy. Intervention 1: Intervention group: Allogeneic Stem Cell Injection in the area with partial rupture with Ultrasound-guided Lateral Approach. Intervention 2: Control group: Ultrasound-guided injection of corticosteroid in the subacromial space with the lateral approach. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Nariman samadaeian
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1201 nariman.samadaeian@gmail.com Iran University of Medical Sciences scientific Dr. Arash Babaei
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
Tehran Iran (Islamic Republic of) 1593747811 +98 82141229 babaei-ghazani.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) The presence of tendinopathy in patients with positive shoulder specific tests including: Neer test, Hawkins test Visual Analogue Scale more than 4 Lack of history of poor control Diabetes, coagulopathy, fractures, rheumatologic diseases, tumors and systemic disease infection No history of shoulder injections in the last 4 months Patient's age 18 to 65 years No pregnancy or decision to become pregnant Lack of risk factor for intra articular injection such as coagulation disorders or Use of anticoagulants Lack of mental disorder Patient willingness to participate in research project 18 years 65 years Both Patients who have not been followed for any reason Changes in the patient's treatment according to the physician or Other treatment by the patient during the study History of shoulder surgery Complete rotator cuff rupture History of cervical radiculopathy Myofascial trigger points M75.4 Impingement syndrome of shoulder Treatment - Other Treatment - Other Intervention group: Allogeneic Stem Cell Injection in the area with partial rupture with Ultrasound-guided Lateral Approach Control group: Ultrasound-guided injection of corticosteroid in the subacromial space with the lateral approach. The severity of symptoms. Timepoint: Zero, two weeks , three months , six months later (Since the injection). Method of measurement: Visual Analog Scale (VAS). Shoulder Pain and Disability. Timepoint: Zero, two weeks , three months , six months later (Since the injection). Method of measurement: Quick Disabilities of Arm, Shoulder & Hand (Quick DASH). Side effects. Timepoint: 30 minutes and tow weeks (Since the injection). Method of measurement: Physical examination. Iran University of Medical Sciences Approved 2019-04-07 Ethics Committee of Iran Universiy of Medical Science Medical faculty, Iran University of Medical Sience, Hemmat High way Tehran Tehran Iran (Islamic Republic of)