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IRCT20100718004409N12 IRCT 2019-09-28 Iran University of Medical Sciences The comparison of effectiveness of high leukocyte and low leukocyte PRP in tendinopathy and partial tear of rotator cuff The comparison of the effectiveness of high leukocyte PRP, low leukocyte PRP & placebo in treatment of the patients having rotator cuff tendinopathy or partial tear 2019-01-21 anticipated 75 Complete https://irct.ir/trial/39660 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The included patients will be randomized in a simple randomization method. The random number tables found in the most statistical text books will be used for the random numbers. The numbers between 0-24 are considered for the first group, 25-49 for the second group and 50 -75 for the third group. The 3 groups are 1- high leukocyte-PRP, 2- low leukocyte PRP & 3- the placebo group. concealment is performed in sequentially numbered, sealed & opaque envelopes, and will be kept by the department secretory, Blinding description: After randomization the patients of the each group will be introduced to the researcher 2 by the researcher 1 for evaluation of the outcomes. The researcher 2 only evaluates the outcomes and records the findings without being informed of the intervention and its effects. The analyzer receives the data at the end of the study and is not informed of the intervention groups at all. The patients are not informed about the injected syringe. Blood of the patients in the three groups will be centrifuged then the plasma in the groups 1 and 2 and the normal saline of the control group will be pulled in a covered syringe injected will be covered. 3 Condition 1: rotator cuff tendinopathy, partial tear of rotator cuff. Condition 2: Shoulder impingement. Intervention 1: Intervention group 1: Platelet rich plasma with high leukocyte 20 cc blood will be centrifuged in two 10- minute steps by Rooyagen kit then the 2 cc of the plasma will be drained. Intervention 2: Intervention group: Platelet rich plasma with low leukocyte in this group the 2 cc of plasma will not be drained. Intervention 3: Intervention group 3 or control group: placebo injection 0.5 cc normal saline will be injected in the shoulder. No - There is not a plan to make this available Justification or reason for not sharing IPD is Unawareness of this item
public Parisa Nejati
Rasool hospital, Niayesh st.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 5001 parisanejati2@gmail.com Iran University of Medical Sciences scientific Parisa Nejati
Rasool hospital, Niayesh street, Sattarkhan street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 5001 parisanejati@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Shoulder pain lasted more than 6 weeks At least 3 positive specific shoulder tests MRI findings implying tendinopathy or partial tear of rotator cuff 40 years no limit Both Shoulder pain that lasted less than six weeks The presence of sensory or motor disturbances caused by the cervical radiculer pain Evidence from other pathologies that can lead to shoulder pain. For example, the presence of calcified tendonitis or adhesive capsulitis and ... History of shoulder surgery in the last 6 months The presence of inflammatory rhomatologic diseases such as rheumatoid arthritis, fibromyalgia, poly mialia rheumatica and ... Complete rupture of rotator cuff tendons based on MRI findings The presence of ligamentous laxity or shoulder instability based on physical examination History of corticosteroid, analgesic or hyaluronic acid injection in the shoulder joint over the past 3 months History of exercise therapy and physiotherapy modalities over the past 6 weeks The history of treatment with PRP in the last 6 months Use of other therapies during the intervention period Patients request for discontinuing the treatment Contraindications for performing MRI or PRP in patients Any non-rheumatologic inflammatory disease and severe acute infection in patients Thrombocytopenia in patients M75.1 M75.40 Rotator cuff tear or rupture, not specified as traumatic Impingement syndrome of unspecified shoulder Treatment - Other Treatment - Other Placebo Intervention group 1: Platelet rich plasma with high leukocyte 20 cc blood will be centrifuged in two 10- minute steps by Rooyagen kit then the 2 cc of the plasma will be drained Intervention group: Platelet rich plasma with low leukocyte in this group the 2 cc of plasma will not be drained Intervention group 3 or control group: placebo injection 0.5 cc normal saline will be injected in the shoulder Pain amount. Timepoint: Before intervention, 1 ,3 ,6 months after intervention. Method of measurement: Visual Analog Scale. Function of the patients. Timepoint: Before intervention, 1 ,3 ,6 months after intervention. Method of measurement: WORC & DASH questionnaires. Shoulder range of motion. Timepoint: Before the intervention, 1,3,6 months after intervention. Method of measurement: Goniometry. Rotator cuff strength. Timepoint: Before the intervention, 1,3,6 months after intervention. Method of measurement: Muscle Manual Test. Iran University of Medical Sciences Approved 2019-05-22 Ethic committee of Iran university of medical sciences Iran University of Medical Sciences, Near the Milad Tower,Hemmat highway Tehran Tehran Iran (Islamic Republic of)