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IRCT20240126060813N1 IRCT 2024-03-04 Shahid Beheshti University of Medical Sciences Comparison of the Effect of Collagen and Corticosteroid Intra-articular Injection on Function and Pain in Patients with First Carpometacarpal Joint Osteoarthritis Comparison of the Effect of Collagen and Corticosteroid Intra-articular Injection on Function and Pain in Patients with First Carpometacarpal Joint Osteoarthritis 2024-04-20 anticipated 50 Complete https://irct.ir/trial/75386 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, 50 patients with a diagnosis of first Carpometacarpal Joint Osteoarthritis will be included in the study randomly For random allocation of individuals in the study groups (intervention or intervention group and comparison or comparison group), the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 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 two type of cards which are including group a (intervention group) and b (comparison group) and these cards are placed inside the 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: The researcher, patients and the collaborator of the project who will perform the statistical analysis will not be aware of the study. grouping of patients will be noted and will be shared to one of the partners. 3 Condition 1: First Carpometacarpal Joint Osteoarthritis. Condition 2: First Carpometacarpal Joint Osteoarthritis. Intervention 1: Intervention group: 25 patients with osteoarthritis of the first carpometacarpal joint who will be treated with intra-articular injection of collagen. Intervention 2: Control group: 25 patients with osteoarthritis of the first carpometacarpal joint who will be treated with intra-articular injection of Corticosteroids. 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 dmfk.pmr@gmail.com How to obtain: Sending an email of requesting information and explaining the purpose and how to use the data Comments:
public Mohammad Faghihi Kashani
Physical Medicine and Rehabilitation Research Center, Shohada Tajrish hospital, Qods square, Tajrish Square, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2272 4210 dmfk.pmr@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Mansoor Rayegani
Physical Medicine and Rehabilitation Research Center, Shohada Tajrish hospital, Qods square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2272 4210 Rayegani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with first carpometacarpal osteoarthritis based on radiographic criteria grade 2 and 3 and have moderate to severe pain (VAS>=5) in the first carpometacarpal joint for at least 3 months, which is resistant to drug treatment. 40 years 70 years Both The patient's willingness to withdraw from the study at any stage of the design The presence of any acute or chronic infection of the joint or around the joint Pregnancy Any intra-articular injection of the first carpometacarpal joint was performed during the last three months. History of oral and systemic corticosteroid use in the last two weeks Use of NSAIDs within 2 weeks prior to injection Existence of inflammatory joint diseases such as rheumatoid arthritis, spondyloarthropathies, connective tissue diseases, gout, Paget's, septic arthritis History of neurological syndromes caused by entrapment of the peripheral nerves of the hands, such as carpal tunnel syndrome History of surgery in the hand Recent history of severe trauma to the hand Having a severe underlying disease such as uncontrolled diabetes Autoimmune and platelet disorders, treatment with anticoagulant and antiplatelet drugs within 10 days before injection Daily use of opioid and non-opioid analgesics Taking topical painkillers Hemarthrosis Erythema or psoriatic lesions at the injection site M18.1 M18.0 Unilateral primary osteoarthritis of first carpometacarpal joint Bilateral primary osteoarthritis of first carpometacarpal joints Treatment - Drugs Treatment - Drugs Intervention group: 25 patients with osteoarthritis of the first carpometacarpal joint who will be treated with intra-articular injection of collagen. Control group: 25 patients with osteoarthritis of the first carpometacarpal joint who will be treated with intra-articular injection of Corticosteroids. Pain in base of thumb. Timepoint: At the beginning of the study (before the start of the intervention) and one month and three months after the intervention. Method of measurement: Visual analogue scale (VAS). Patient 's function. Timepoint: At the beginning of the study (before the start of the intervention) and one month and three months after the intervention. Method of measurement: FIHOA questionnaire scores. The strength of the thumb. Timepoint: At the beginning of the study (before the start of the intervention) and one month and three months after the intervention. Method of measurement: Dynamometer. The need for painkillers. Timepoint: At the beginning of the study (before the start of the intervention) and one month and three months after the intervention. Method of measurement: questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-07-01 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)