Dose-Response Effect of Intra-Articular Ozone in Knee Osteoarthritis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorKayseri City Hospital

About this trial

The goal of this clinical trial is to evaluate the clinical efficacy of different doses of intra-articular ozone injections combined with exercise in patients aged 40-75 diagnosed with Grade 2-3 knee osteoarthritis.

The main questions it aims to answer are:

* Which intra-articular ozone doses (10 µg/mL, 15 µg/mL, or 20 µg/mL) is most effective in improving pain and physical function in knee osteoarthritis? * Do combined ozone and exercise therapies provide superior clinical outcomes compared to exercise therapy alone? Researchers will compare four groups (Ozone 10 µg/mL + Exercise, Ozone 15 µg/mL + Exercise, Ozone 20 µg/mL + Exercise and Exercise Alone) to see the dose-dependent effects of ozone therapy.

Participants will:

* Complete a structured home exercise program for the duration of the study. * Receive 3 sessions of intra-articular ozone injections (for patients allocated to the ozone groups). * Participate follow-up visits for clinical and functional assessments at baseline (before the procedure), immediately after the 3rd injection session, at 1 month after the last ozone injection, and at 3 months after the last ozone injection.

Eligibility criteria

Qualifiers

Patients aged 40-75 years diagnosed with knee osteoarthritis according to the American College of Rheumatology 2019 criteria

Grade 2 or 3 knee osteoarthritis based on the Kellgren-Lawrence radiological classification system.

Presence of chronic knee pain lasting for more than 6 months.

Numerical Rating Scale score of 3 or higher during knee-loading activities

Disqualifiers

Presence or history of acute knee infection, major knee trauma, or inflammatory arthritis

History of knee fracture or surgical intervention involving the affected knee joint within the last 6 months.

History of intra-articular injections (e.g., corticosteroids, hyaluronic acid, PRP) into the affected knee joint within the last 6 months.

History of physical therapy or rehabilitation in the knee region within the last 6 months

Trial design

Treatments tested in this trial

  • ozone injection
  • Exercise

Treatment groups

80 Participants
are divided into 4 treatment groups

Sponsors and collaborators