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IRCT20130523013442N38 IRCT 2026-04-22 Shahid Beheshti University of Medical Sciences Study and comparison of the effectiveness of high-intensity laser and intra-articular laser treatment followed by ultrasound-guided platelet-rich plasma (PRP) injection on improving symptoms in patients with knee osteoarthritis Study and comparison of the effectiveness of high-intensity laser and intra-articular laser treatment followed by ultrasound-guided platelet-rich plasma (PRP) injection on improving symptoms in patients with knee osteoarthritis 2025-11-26 anticipated 40 Complete https://irct.ir/trial/89203 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial, 40 patients diagnosed with knee osteoarthritis will be randomly enrolled in the study. Block Randomization will be used to randomly assign individuals to the study groups. In this method, blocks of 4 will be used with a 1:1 ratio. Random Allocation software will be used to generate random sequences. Random Allocation software will be used to generate random sequences. The random sequences generated in this method, which are identified by the letters A (group receiving high-intensity laser followed by PRP) and B (group receiving intra-articular laser followed by PRP), will be recorded on cards and these cards will be placed in sealed envelopes in order.Finally, the numbered envelopes will be placed in a folder. Then, based on the order of entry of the eligible participants, the envelopes will be opened and the assigned group of that participant will be determined, Blinding description: In this study, due to the nature of the study, it was not possible to blind the patient and the researcher. Only the data analyst will be kept blind and will not be informed of the intervention performed on each group of patients. Only the final data in the form of the first and second groups of random numbers assigned to each patient will be made available to them. 3 Knee osteoarthritis. Intervention 1: Intervention group: Includes 20 patients who undergo intra-articular injection of 5 cc PRP in three injections at two-week intervals along with 10 high-intensity laser sessions, two sessions per week. Intervention 2: Intervention group: Includes 20 patients who undergo intra-articular injection of 5 cc PRP in three injections at two-week intervals, along with 3 intra-articular laser sessions immediately after each PRP session. Yes - There is a plan to make this available What will be shared: All data from study participants can be shared after de-identifying individuals. When: Access period begins one year after results are published. To whom: The data from this study will be available to researchers working in academic and scientific institutions. Conditions: If the researchers' goal is to conduct a systematic review and meta-analysis of the data, non-identifiable patient data will be made available to the researchers. Where to obtain: By sending an email to s.mohammadabusaeedi@gmail.com How to obtain: The request must include information about the applicant, their place of work, phone number, email, and the reason for their request. If these items are provided and the applicant's plan information is registered and approved in the PROSPERO system, the information will be made available to the applicant. Comments:
public Mohammad eyed abusaeedi
Saadat Abad, Kaj Square, Shahid Modarres Hospital
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 s.mohammadabusaeedi@gmai.com Shahid Beheshti University of Medical Sciences scientific Seyyed Ahmed Raeis Sadat
Saadat Abad, Kaj Square, Shahid Modarres Hospital
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) Individuals 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. Diagnosis is confirmed using knee radiography (Kellgren–Lawrence grade 2-3). Patient's BMI is between 18 and 30. Patient's willingness 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 ulcer in the knee area Recent history of severe knee injury Autoimmune and platelet disorders Treatment with anticoagulant and antiplatelet drugs within 10 days prior to injection Use of NSAIDs within 2 days prior to injection History of intramuscular injection or oral administration of systemic corticosteroids 2 weeks prior to injection History of any intra-articular knee injection within the past 6 months Hemoglobin less than 11 g/dL Platelet count less than 150,000/mL History of vasovagal shock Pregnancy or breastfeeding Genu valgum/varum greater than 20 degrees Hemarthrosis, erythema, and psoriatic lesions Clinical or paraclinical signs in favor of spinal canal stenosis, neuropathy, or active lumbar radiculopathy M17 Osteoarthritis of knee Treatment - Other Treatment - Other Intervention group: Includes 20 patients who undergo intra-articular injection of 5 cc PRP in three injections at two-week intervals along with 10 high-intensity laser sessions, two sessions per week. Intervention group: Includes 20 patients who undergo intra-articular injection of 5 cc PRP in three injections at two-week intervals, along with 3 intra-articular laser sessions immediately after each PRP session. Assessment of knee pain. Timepoint: At the beginning of the study (before the intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Based on the visual pain index, WOMAC questionnaire, and Lequesne index. Assessing the patient's performance in performing daily tasks. Timepoint: At the beginning of the study (before the intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Using the WOMAC questionnaire. Assessing morning dryness. Timepoint: At the beginning of the study (before the intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: Using the WOMAC questionnaire and Lequesne index. Patient satisfaction with treatment. Timepoint: At the beginning of the study (before the intervention) and 4 weeks and 24 weeks after the intervention. Method of measurement: 5-choice questionnaire. Shahid Beheshti University of Medical Sciences Approved 2025-11-22 Ethics Committee of Shahid Beheshti University of Medical Sciences Tehran, Shahid Chamran Highway, Yemen Street, next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)