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IRCT20190306042945N8 IRCT 2026-09-29 Iran University of Medical Sciences Comparison of Intra-Articular Corticosteroid Injection and Intra-Articular Laser Therapy for the Treatment of Knee Osteoarthritis IALT Comparison of the Effects of Intra-Articular Corticosteroid Injection and Intra-Articular Laser Therapy in Patients with Knee Osteoarthritis 2026-09-06 anticipated 54 Recruiting https://irct.ir/trial/92373 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to one of two treatment groups using block randomization with a block size of 6: Group 1: Intra-articular corticosteroid injection Group 2: Intra-articular laser therapy (IALT) For randomization, a set of small papers of identical size, color, and material will be prepared. Each paper will be labeled with a number indicating the treatment group (number 1 for corticosteroid injection and number 2 for laser therapy). Based on a sample size of 54 participants, nine complete blocks, each containing 6 participants, will be designed. Within each complete block, three allocations will be assigned to Group 1 and three allocations to Group 2. The sequence of group assignments within each block will be generated completely at random using Random Allocation Software, Blinding description: This study is designed as a double-blind trial; both the participants and the personnel responsible for completing the questionnaires will be unaware of treatment-group allocation. However, given the practical and ethical limitations arising from the inherent differences between the interventions (drug versus energy), complete blinding of the interventionist is not feasible in this protocol. Therefore, the primary focus will be on maintaining blinding of participants and outcome assessors. Group A (Corticosteroid): Participants will receive an ultrasound-guided intra-articular injection of 40 mg triamcinolone acetonide. To simulate the laser procedure, an inactive optical fiber with a visible red indicator light will be introduced through the same needle, without delivery of therapeutic energy. Group B (Laser therapy): Participants will receive intra-articular laser therapy using a 658-nm wavelength (red light) at a power of 50 mW for 20 minutes (total energy: 60 J), delivered through a sterile optical fiber inserted using a 22-gauge needle. To simulate drug injection, 0.5 mL of normal saline will be injected and subsequently aspirated/reinjected to reproduce the physical sensation of an injection. To assess the success of blinding, participants and outcome assessors will periodically be asked to guess the assigned treatment group. These data will be recorded and evaluated in sensitivity analyses to assess the potential impact of lack of interventionist blinding on the study results. 3 Knee Osteoarthritis. Intervention 1: Intervention group :Participants receive intra-articular low-level laser therapy with a wavelength of 658 nm (red light), output power of 50 mW, for 20 minutes (total energy of 60 J) in a single session. The procedure is performed under ultrasound guidance using a sterile optical fiber introduced via a 22-gauge needle into the knee joint space. For blinding and simulating drug injection, 0.5 mL of normal saline is injected and re-aspirated to reproduce the physical sensation of injection. Intervention 2: Control group: Participants receive 40 mg (1 mL) of triamcinolone acetonide injectable suspension intra articularly under ultrasound guidance in a single session. For blinding and simulating the laser procedure, an inactive optical fiber with a red guide light (delivering no therapeutic energy) is inserted through the same needle into the joint space for 20 minutes. Yes - There is a plan to make this available What will be shared: All data is shareable, provided it has been fully de-identified. When: Access will be available starting 6 months after the publication of the results. To whom: Access is restricted to researchers affiliated with academic and scientific institutions. Conditions: For future research use, please submit a written request via email. Where to obtain: Principal Investigator: Dr. Bijan Forogh Email: forogh.b@iums.ac.ir How to obtain: Upon submission of your request, data access will be provided within approximately one week. Comments:
public Mahtab Khalajzadeh
**Firoozgar Hospital, Behafarin Street, Karim Khan Zand Street, Valiasr Square, Tehran, Iran**
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1612 mahtab.khalajzadeh279@gmail.com Iran University of Medical Sciences scientific Bijan Forogh
**Firoozgar Hospital, Behafarin Street, Karim Khan Zand Street, Valiasr Square, Tehran, Iran**
Tehran Iran (Islamic Republic of) 1593747811 009882141612 forogh.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age between 45 and 75 years Diagnosis of knee osteoarthritis based on the American College of Rheumatology (ACR) clinical and radiographic criteria Kellgren–Lawrence grade 2 or 3 knee osteoarthritis (mild-to-moderate OA) Knee pain score of ≥4 out of 10 on the Visual Analogue Scale (VAS) Willingness to participate in the study and provision of written informed consent 45 years 75 years Both History of intra-articular injection within the past 3 months, including corticosteroids, hyaluronic acid, platelet-rich plasma (PRP), or other injectates History of major knee surgery or planned total or partial knee arthroplasty Diagnosis of inflammatory arthritis, such as rheumatoid arthritis, gout, or psoriatic arthritis Secondary causes of osteoarthritis, such as post-traumatic osteoarthritis Coagulation disorders or current use of anticoagulant therapy Active infection Malignancy Diabetes mellitus Concurrent use of systemic corticosteroids Pregnancy or breastfeeding Known hypersensitivity to corticosteroids or laser-therapy–related components Use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids within the past 7 days M17.10 Unilateral primary osteoarthritis, unspecified knee Treatment - Devices Treatment - Drugs Intervention group :Participants receive intra-articular low-level laser therapy with a wavelength of 658 nm (red light), output power of 50 mW, for 20 minutes (total energy of 60 J) in a single session. The procedure is performed under ultrasound guidance using a sterile optical fiber introduced via a 22-gauge needle into the knee joint space. For blinding and simulating drug injection, 0.5 mL of normal saline is injected and re-aspirated to reproduce the physical sensation of injection. Control group: Participants receive 40 mg (1 mL) of triamcinolone acetonide injectable suspension intra articularly under ultrasound guidance in a single session. For blinding and simulating the laser procedure, an inactive optical fiber with a red guide light (delivering no therapeutic energy) is inserted through the same needle into the joint space for 20 minutes. Pain score. Timepoint: Before the intervention,7 days and 30 days after the intraarticular injection. Method of measurement: Visual analog scale. Iran University of Medical Sciences Approved 2026-03-14 Research Ethics Committee, School of Medicine, Iran University of Medical Sciences Vice-Chancellery for Research and Technology, Central Headquarters Building, Iran University of Medical Sciences, adjacent to Milad Tower, Hemmat Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)