Dose-Response for Intra-Articular Ozone in Knee Osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized trial compares three ozone doses (10, 15, and 20 µg/mL) plus exercise to exercise alone in adults with Kellgren-Lawrence grade 2–3 knee OA. Participants receive three weekly intra-articular ozone injections alongside a structured home exercise program and are followed with clinical and functional assessments over 3 months. The goal is to determine the dose-dependent effects of ozone on pain and physical function and whether ozone adds benefit to exercise. The study is conducted at Kayseri City Hospital, with participants allocated by computerized randomization. All groups follow the same home exercise protocol, including ROM, strengthening, and flexibility exercises.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Presence of osteomyelitis adjacent to the knee joint, bacteremia, or hemarthrosis.
* History of malignancy involving the lower extremity.
* Known hypersensitivity or allergy to medical ozone.
* Severe anemia, thrombocytopenia, active bleeding disorders, or ongoing anticoagulant therapy.
* Pregnancy or lactation
* Active infection
* Severe systemic diseases (e.g., advanced cardiopulmonary disease, uncontrolled diabetes mellitus).
* Hyperthyroidism or progressive neuromuscular disorders.
* Cognitive impairment or inability to cooperate with the assessment tools and study protocol.

Where it's running

• Kayseri City Hospital
  Kayseri, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Serhat Efdal Ozbek, MD
• Email: serhatefdal60@gmail.com
• Phone: +905072387257

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.