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

The aim of this study was to compare the effectiveness of high-intensity laser and intra-articular laser followed by ultrasound-guided platelet-rich plasma injection in reducing pain, improving function, and satisfaction with treatment in patients with knee osteoarthritis.

A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 40 patients. Randomization software is used for randomization.

Using a sealed envelope, the outcome assessor and data analyst will be blinded to the treatment group, and the patients will be randomly divided into 2 groups of 20. The study site will be Shahid Modarres Hospital, Tehran.

Individuals aged 40 to 70 years with a BMI between 18 and 30 who were diagnosed with knee osteoarthritis based on history and physical examination and confirmed by knee radiography (Kellgren–Lawrence grade 2-3) and had symptoms lasting more than 3 months. Exclusion criteria included: history of uncontrolled diabetes, immunodeficiency, and collagen disorders ;use of NSAIDs within 2 days prior to injection; pregnancy or lactation; genu valgum/varum greater than 20 degrees; clinical or paraclinical signs in favor of spinal canal narrowing, neuropathy, or active lumbar radiculopathy.

Intervention group 1: Includes 20 patients who undergo three PRP injections every two weeks and then 10 sessions of high-intensity laser treatment twice a week. Intervention group 2: Includes 20 patients who undergo three PRP injections every two weeks and then 3 sessions of intra-articular laser treatment immediately after each PRP treatment.

Assessing the level of pain and stiffness in the knee joint, assessing the patient's performance in performing daily tasks, and the level of satisfaction with treatment.

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.

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.

All data from study participants can be shared after de-identifying individuals.

Access period begins one year after results are published.

The data from this study will be available to researchers working in academic and scientific institutions.

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.

By sending an email to s.mohammadabusaeedi@gmail.com

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.