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IRCT20260420069117N1 IRCT 2026-05-20 Tehran University of Medical Sciences Comparison of PRP injection with or without high-power laser for knee osteoarthritis Comparison of the short-term efficacy of intra-articular platelet-rich plasma injection alone versus intra-articular platelet-rich plasma injection combined with high-power laser therapy on pain and physical function in patients with grade 1-3 knee osteoarthritis 2026-04-30 anticipated 48 Recruiting https://irct.ir/trial/89601 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: No applicable, Randomization description: Method: Block randomization (restricted randomization) with fixed block size of 12. Four blocks will be used, each containing 6 allocations to PRP alone group and 6 allocations to PRP+HILT group. Unit of randomization: Individual patient. Tools: Random number generation using R software to randomly select 4 numbers from 1 to 4 for block order. Allocation concealment using sequentially numbered, sealed, opaque envelopes. Each random sequence is recorded on a card placed inside an envelope. Envelopes are numbered externally in sequence and opened in order of participant enrollment, Blinding description: This is a single-blind (patient-blinded) study. The blinding is achieved as follows: Participants (patients): Blinded. For patients in the PRP-only group (Group 1), a sham laser procedure is performed with the same device, same duration (6 minutes), same positioning and sound effects, but with zero watt power output. Patients in the PRP+HILT group (Group 2) receive real laser therapy. All patients are unaware of their group allocation. Principal investigator: Not blinded. The investigator knows which patient receives which intervention. Healthcare providers (interventionists/laser operator): Not blinded. The laser operator must know the actual power settings to deliver real or sham laser accordingly. Data collectors: Not applicable separately, as outcome assessors are described below. Outcome assessors: Blinded. The physician or trained personnel who administer the VAS and WOMAC questionnaires at baseline, 1 month and 3 months follow-up are unaware of the patients' group allocation. Assessments are performed before laser session (for Group 2) and at the same time points for both groups. Data Safety and Monitoring Board (DSMB): Not applicable (no DSMB for this trial). Manuscript writers: Not blinded during analysis; however, group allocation will be coded (e.g., Group A and Group B) until final analysis is completed. N/A Knee osteoarthritis (Knee OA) is a chronic degenerative joint disease characterized by progressive destruction of articular cartilage, synovial inflammation, and subchondral bone changes. It leads to persistent pain, stiffness, and functional disability. This study specifically includes patients with grade 1, 2, or 3 knee osteoarthritis based on radiographic criteria (Kellgren-Lawrence classification).. Intervention 1: Control group: Platelet-rich plasma (PRP) injection alone. Preparation method: 20 mL of venous blood is drawn with 3 mL of anticoagulant (citrate dextrose solution A or acid citrate dextrose), divided equally into 4 tubes. Double centrifugation method: first centrifugation at 1800 rpm for 15 minutes, plasma is transferred to a new tube, second centrifugation at 1800 rpm for 12 minutes. Final product is 4 mL of PRP with platelet concentration 5 to 6 times baseline (approximately 1-1.5 million platelets per microliter). A single intra-articular injection of 4 mL PRP is administered to the affected knee under sterile conditions. No further intervention is given. Sham laser (0 watt) is applied for 6 minutes with the same device appearance and duration to maintain blinding. Manufacturer of centrifuge and PRP preparation kit: to be specified based on hospital procurement. Intervention 2: Intervention group: Platelet-rich plasma (PRP) injection followed by high-intensity laser therapy (HILT). PRP preparation and injection protocol is identical to Intervention group 1 (4 mL PRP, single intra-articular injection, platelet concentration 5-6 times baseline). One to two weeks after PRP injection, a single session of HILT is performed. Laser parameters: pulsed mode, maximum power 12 watts, average power 7 watts, dose 50 Joules per square centimeter applied to each 64 square centimeters of the anterior knee area, frequency 10 Hertz, total duration 6 minutes. Laser device: High-intensity laser therapy system (specific manufacturer and model to be specified based on hospital equipment, e.g., ASA Laser or similar class 4 laser device). No sham procedure is applied to this group. Yes - There is a plan to make this available What will be shared: After deidentifying people, all the data obtained from the research, including the demographic information of the samples, clinical information and the results of the intervention can be shared. When: It is possible to access the results after nine to twelve months from the publication of the results. To whom: Researchers in academic centers and scientific research centers. Conditions: In order to data comparison in similar studies, the researchers of academic centers and scientific research centers have the possibility to receive data and re-analyze it if they comply with the principles of ethics in research. Where to obtain: Dr Alireza naeiji with below email address: alirezanaeiji3@gmail.com and phone number:+989116899200 How to obtain: Researchers should send a written request to receive data to the relevant email address.A week after receiving an email , it will take action. Comments:
public Alireza Naeiji
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Tehran Iran (Islamic Republic of) 1417913191 +98 911 689 9200 alirezanaeiji@gmail.com Tehran University of Medical Sciences scientific Alireza Naeiji
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Tehran Iran (Islamic Republic of) 1417913191 +98 911 689 9200 alirezanaeiji@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 30 and 70 years Diagnosis of knee osteoarthritis grade 1, 2 or 3 based on ACR clinical and radiographic criteria Knee pain for at least 6 months Visual Analogue Scale (VAS) score of at least 3 No satisfactory response to at least one conservative treatment (acetaminophen, NSAIDs, assistive devices, lifestyle modification or weight loss) At least two weeks washout period from last NSAID or corticosteroid use No history of knee injection in the last three months 30 years 70 years Both Pregnancy or breastfeeding Inflammatory rheumatic diseases Severe heart disease Active skin infection at the injection site Use of immunosuppressive drugs Use of anticoagulants (warfarin or heparin) History of bleeding diathesis or current coagulation disorders Active low back pain with radiation to lower limbs History of knee surgery in the last 3 months Active infection or malignancy in the last 6 months Substance abuse Intra-articular corticosteroid injection in the last 3 months Intra-articular hyaluronic acid injection in the last 6 months M17.9 Osteoarthritis of knee, unspecified Treatment - Drugs Treatment - Devices Control group: Platelet-rich plasma (PRP) injection alone. Preparation method: 20 mL of venous blood is drawn with 3 mL of anticoagulant (citrate dextrose solution A or acid citrate dextrose), divided equally into 4 tubes. Double centrifugation method: first centrifugation at 1800 rpm for 15 minutes, plasma is transferred to a new tube, second centrifugation at 1800 rpm for 12 minutes. Final product is 4 mL of PRP with platelet concentration 5 to 6 times baseline (approximately 1-1.5 million platelets per microliter). A single intra-articular injection of 4 mL PRP is administered to the affected knee under sterile conditions. No further intervention is given. Sham laser (0 watt) is applied for 6 minutes with the same device appearance and duration to maintain blinding. Manufacturer of centrifuge and PRP preparation kit: to be specified based on hospital procurement. Intervention group: Platelet-rich plasma (PRP) injection followed by high-intensity laser therapy (HILT). PRP preparation and injection protocol is identical to Intervention group 1 (4 mL PRP, single intra-articular injection, platelet concentration 5-6 times baseline). One to two weeks after PRP injection, a single session of HILT is performed. Laser parameters: pulsed mode, maximum power 12 watts, average power 7 watts, dose 50 Joules per square centimeter applied to each 64 square centimeters of the anterior knee area, frequency 10 Hertz, total duration 6 minutes. Laser device: High-intensity laser therapy system (specific manufacturer and model to be specified based on hospital equipment, e.g., ASA Laser or similar class 4 laser device). No sham procedure is applied to this group. Pain severity measured by Visual Analogue Scale (VAS). The VAS is a 10-centimeter horizontal line with 0 meaning "no pain" and 10 meaning "worst imaginable pain". Patients mark their current pain level on this line. Timepoint: Before injection (baseline), 1 month after injection, 3 months after injection. Method of measurement: Visual Analogue Scale (VAS) - a self-administered 10-centimeter horizontal line scale. The patient places a mark on the line corresponding to their perceived pain intensity. The distance from zero to the mark is measured in millimeters, yielding a score from 0 to 100 (or 0 to 10 when converted). Physical function measured by the physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This subscale contains 17 questions assessing difficulty with daily activities such as walking, climbing stairs, rising from sitting, standing, bending, and household tasks. Timepoint: Before injection (baseline), 1 month after injection, 3 months after injection. Method of measurement: Persian version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscale. Each of the 17 questions is scored from 0 (no difficulty) to 4 (extreme difficulty). The total subscale score ranges from 0 to 68. Higher scores indicate worse physical function. Tehran University of Medical Sciences Approved 2026-04-20 Research Ethics Committee of Imam Khomini Hospital Educational, Research and Treatment Center - Tehr End of Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)