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IRCT20130523013442N34 IRCT 2023-09-23 Shahid Beheshti University of Medical Sciences Comparison of intra-articular injection of hydrolyzed type 1 collagen, platelet-rich plasma and hyaluronic acid on pain, stiffness and performance of patients with knee osteoarthritis Comparison of intra-articular injection of hydrolyzed type 1 collagen, platelet-rich plasma and hyaluronic acid on pain, stiffness and performance of patients with knee osteoarthritis 2023-09-23 anticipated 120 Complete https://irct.ir/trial/72564 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: in this clinical trial study, 60 patients with a diagnosis of frozen shoulder will be included in the study randomly .For random allocation of individuals in the study groups, the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including two people in in each of the three groups) with a ratio of 1:1:1 will be used. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with three types of cards which are identified by the letters A (hydrolyzed collagen recipient group), B (PRP recipient group) and C (hyaluronic acid recipient group). Cards will be recorded and these cards will be placed in sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined, Blinding description: In this study, the researcher, the patient, the data analyst and the outcome evaluator are kept blind and are not aware of the intervention performed on each group of patients, and only the final data are assigned to the first, second, and third groups of random numbers. 3 Osteoarthritis of knee. Intervention 1: Intervention group: includes 40 patients who are treated with CHondroGrid (Bioteck) made of hydrolyzed collagen diluted in 2 cc of normal saline هn three injections with two-week intervals. Intervention 2: Intervention group: Includes 40 patients who are treated with intraarticular injection of 5 cc of PRP in three injections with two-week intervals. Intervention 3: Intervention group: includes 40 patients who are treated with 2 cc of hyaluronic acid (Hyalgan) with a molecular weight of 500000-730000 daltons in three injections with two-week intervals intra-articularly. Yes - There is a plan to make this available What will be shared: All the data of people participating in this study can be shared after deidentifying people When: The access period starts one year after the results are published To whom: Data of this study will be available to researchers working in academic and scientific institutions Conditions: If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers. Where to obtain: By sending an email to alin7093@gmail.com How to obtain: The given request should contain information about his/her affiliation, phone number, e-mail and the reason for his/her request. If these items are presented and the information related to the applicant's plan is registered and confirmed in the PROSPERO system, the information will be provided to the applicant. Comments:
public Ali Nazari Nodoushan
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 alin7093@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Ahmad Raeissadat
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 a_raeissadat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People aged 40 to 70 years who are diagnosed with knee osteoarthritis based on history and physical examination. Duration of symptoms is more than 3 months. Confirmation of diagnosis using knee x-ray (Kellgren-Lawrence grade 2-3) The patient's BMI should be between 18 and 30. Willingness of the patient to participate in the study 40 years 70 years Both History of immunodeficiency and collagen disorders and uncontrolled diabetes History or presence of malignant disorders, infection or active wound in the knee area Recent history of severe knee injury Autoimmune and platelet disorders Treatment with anticoagulant and antiplatelet drugs within 10 days before injection Use of NSAIDs within 2 days before injection History of intramuscular injection or oral use of systemic corticosteroids 2 weeks before injection History of any intra-articular injection of the knee during the last 6 months Hemoglobin less than 11 g/dL Platelet count less than 150,000/ml History of vasovagal shock Pregnancy or breastfeeding Geneva valgum/varum more than 20 degrees Hypersensitivity to hyaluronate Allergy to bovine proteins, poultry products, eggs and collagen Hemarthrosis, erythema and psoriatic lesions Clinical or para-clinical symptoms in favor of spinal canal narrowing, neuropathy or active lumbar radiculopathy M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: includes 40 patients who are treated with CHondroGrid (Bioteck) made of hydrolyzed collagen diluted in 2 cc of normal saline هn three injections with two-week intervals. Intervention group: Includes 40 patients who are treated with intraarticular injection of 5 cc of PRP in three injections with two-week intervals. Intervention group: includes 40 patients who are treated with 2 cc of hyaluronic acid (Hyalgan) with a molecular weight of 500000-730000 daltons in three injections with two-week intervals intra-articularly. Assessment of knee pain. Timepoint: At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Visual analogue scale (VAS), WOMAC and Lequesne index questionnaire. Assessing the patient's performance in daily tasks. Timepoint: At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Using the WOMAC questionnaire. Assessment of morning stiffness. Timepoint: At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Using the WOMAC and Lequesne index questionnaire. The degree of patient's satisfaction with the treatment. Timepoint: At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: 5-items questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-09-10 Research Ethics Committees of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)