Comparison of the effects of platelet-rich plasma versus a combination of platelet-rich plasma and ozone therapy on pain intensity, disability and quality of life in patients with knee osteoarthritis, Randomized Controlled Trial

Comparison of the effects of platelet-rich plasma versus the combination of platelet-rich plasma and ozone therapy on pain intensity, disability, and quality of life in patients with knee osteoarthritis

a clinical trial with a control group, parallel groups, double-blind, randomized, phase 3 on 108 patients. Randomization software was used for randomization.

Each of the interventions (PRP or ozone therapy + PRP) will be presented to the patients 2 times-with 3 weeks interval at Nab pain clinic. After local anesthesia with lidocaine, the intervention groups' Injections are performed by a specialist physician in a supine position and under sterile conditions with the classic suprapatellar intra-articular injection method. Control group receive only gabapentin (100 mg) daily. By using researcher assistants and analysts outside the research team, the data collector and analyst will be blind.

1. Mild to moderate osteoarthritis (OA) (2 or 3) 2. No inflammatory, bleeding disorders and rheumatoid arthritis 4. No endocrine and metabolic diseases 5. Imbalance and limping 6. No pregnancy 7. not perform procedures such as Arthrocentesis in the last six months 8. No joint surgery last year 9. Willingness to participate in the study

PRP Group: In this group, in addition to receiving gabapentin (100 mg), PRP will be injected twice at a dose of 3 ml into the patient's knee (three weeks apart). PRP and ozone therapy group: In this group, in addition to receiving gabapentin (100 mg) and PRP injection, injection of 5 ml of ozone with a concentration of 10 micrograms per ml will be performed twice (three weeks apart). Control group: Patients receive only gabapentin (100 mg) daily.

Pain intensity, disability and quality of life

Considering the treating physician's opinion about using pain management methods, the eligible patients referred to the Nab pain clinic with mild to moderate osteoarthritis interested in participating in the study are selected. In this study, block randomization will be used. The size of all blocks is equal. In this three-group trial, we will have nine blocks (including 3 participants in the PRP group, 3 participants in the PRP + ozone therapy combination group, and 3 participants in the drug therapy group). Research Randomizer (randomizer.org) will be used to create random sequences. Allocation of patients into the groups will be concealed using sequence, uniform, opaque, and sealed envelopes which are numbered from one to 108. Envelope number one is given to the first patient included in the study, and this process will continue until the end. Therefore, the participants and the researcher will have no information about the type of intervention until the envelopes are opened. A clinician who is not involved in the research will perform the outcomes assessment of this study. In the current study, the outcome investigator and statistical analyzer will be blind to the type of intervention.

In this study, to blind and prevent possible bias, dividing patients into three groups, interviewing patients to complete the questionnaire, interpreting the questionnaire, entering and interpreting data, and analyzing information in statistical software will be done by nurses and statistics outside the study. In this study, the data analyzer will not be aware of the grouping of patients, and only the physician performing the injection will be aware of the assignment of individuals to the groups.

Anonymous study data will be shared in correspondence with the project manager.

Access period starts 6 months after the results are published

Researchers working in academic and scientific institutions

Systematic reviews and meta-analyses

Contact via email: m2620.shaygan@gmail.com

After receiving the official request for data, the executor of the project sends the request to the Security Unit and the Vice Chancellor for Research of Shiraz University of Medical Sciences and in case of obtaining permission to provide data, the data will be provided to the person within a period of approximately 1 month.