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IRCT20250305064943N1 IRCT 2025-05-02 Tehran University of Medical Sciences Evaluation of the effects of intra-articular injection of platelet-rich plasma (PRP) on patients with knee osteoarthritis Evaluation of the effects of intra-articular injection of platelet-rich plasma (PRP) on pain and function of patients with knee osteoarthritis and comparison of the efficacy between moderate and severe degrees of knee osteoarthritis based on the Kellgren Lawrence classification 2025-05-22 anticipated 82 Complete https://irct.ir/trial/82337 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 4 Knee osteoarthritis. Intervention group: intraarticlar injection of PRP in knee. Yes - There is a plan to make this available What will be shared: The present research has been registered as a proposal for the thesis of the Sports Medicine Residency Program. The resulting thesis from this proposal, including all participant data, study protocol, statistical analyses, and the full study report encompassing all variables, will be submitted to Tehran University of Medical Sciences and the Department of Sports Medicine. It is noteworthy that, upon approval of the thesis, an article containing all the mentioned elements will be published in a journal relevant to the topic of the research. Please note that access to raw data not included in the final report or published article requires direct communication with the principal investigator of the stud When: A period of two years has been estimated for all stages of the study until its submission as a thesis. The data obtained from this research will be submitted for publication as an article after the thesis has been approved at the end of the two-year period. Access to the raw data not included in the final report or the published article will be possible after the article's publication through direct communication with the principal investigator of the study. To whom: The data obtained from this research will be available to all interested individuals, and there will be no restrictions on access. Conditions: There are no restrictions on the use, publication, or further processing of the data from this study, provided that prior communication is established with the principal investigator via email or other means, and the necessary permission is granted by the principal investigator. Where to obtain: To access the information of this study, the interested individual may contact the principal investigator via email or phone. How to obtain: The permission to use the information will be granted to the interested individual as soon as the email is received or the phone contact is made, and the requested information will be promptly sent to the individual via email. Comments:
public Saeideh Soltani
keshavarz Blvd
tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 5270 ss.soltaniiii@gmail.com Tehran University of Medical Sciences scientific Farzin Halabchi
Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 5270 fhalabchi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) People between 40 and 80 years old. People with knee pain who have a VAS score of at least 4 on a standing knee radiograph and at least grade 2 osteoarthritis according to the Kellogg-Lawrence criteria, and who have received supportive treatment for at least 3 months and have not responded to treatment. 40 years 80 years Both Pregnancy or breastfeeding Active cancer active infectious disease Drug or drug addiction History of any knee surgery or major trauma (leading to traumatic injury to the ligaments or meniscus or articular cartilage) Blood and coagulation diseases and use of anticoagulants Known rheumatological disease and fibromyalgia Use of anti-inflammatory medications and supplements (NSAIDs, corticosteroids, vitamins E and C, curcumin, and omega-3) within a week before and after the injection Having a significant physical or mental illness that increases the risk of disruption to the study process History of receiving corticosteroids or PRP in the knee for at least the past 6 months Use of any analgesics and physiotherapy modalities within 72 hours prior to outcome assessment M17 Osteoarthritis of knee Treatment - Drugs Intervention group: intraarticlar injection of PRP in knee WOMAC questionnaire score. Timepoint: First visit, two months, and 6 months after the second injection. Method of measurement: WOMAC questionnaire. Pain(VAS). Timepoint: First visit, two months, and 6 months after the second injection. Method of measurement: Patients are asked to rate the overall pain intensity they experienced over the past 48 hours on a Visual Analogue Scale (VAS) from 1 to 100. The 30 Second Sit to Stand Test. Timepoint: First visit and two months after the second injection. Method of measurement: the number of times a person can stand and sit without using the arm of a chair in 30 seconds. 40 metre fast-paced walk test. Timepoint: First visit and two months after the second injection. Method of measurement: The time it takes for a person to walk a distance of 40 meters at maximum speed without running. Tehran University of Medical Sciences Approved 2025-02-23 Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)