Dose-Response Effect of Intra-Articular Ozone in Knee Osteoarthritis
Key facts
- Who runs it
- Kayseri City Hospital
- Where
- Kayseri, TürkiyeSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 19 Nov 2025
- Expected to end
- 30 Nov 2026
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- ozone injection
- Exercise
- Record updated
- 1 July 2026
Who can take part
- Age
- 40 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- History of malignancy involving the lower extremity
- Known hypersensitivity or allergy to medical ozone
- Severe anemia, thrombocytopenia, active bleeding disorders, or ongoing anticoagulant therapy
- 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
- Presence of osteomyelitis adjacent to the knee joint, bacteremia, or hemarthrosis
- Pregnancy or lactation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Where in Türkiye
- Kayseri City HospitalKayseri, TürkiyeContact: Serhat Efdal Ozbek, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 4 groups in the trial
- 10 µg Ozone + ExerciseTreatment being tested
10 mL of ozone injection at a concentration of 10 µg/mL + Home exercise program
Treatment: ozone injection and Exercise
- 15 µg Ozone + ExerciseTreatment being tested
10 mL of ozone injection at a concentration of 15 µg/mL + Home exercise program
Treatment: ozone injection and Exercise
- 20 µg Ozone + ExerciseTreatment being tested
10 mL of ozone injection at a concentration of 20 µg/mL + Home exercise program
Treatment: ozone injection and Exercise
- Exercise AloneExisting treatment, for comparison
Home exercise program alone
Treatment: Exercise
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Dose-Response Effect of Intra-Articular Ozone in Knee Osteoarthritis: A Randomized Controlled Single-Blind Clinical Study
- Fit questions
- Built from NCT07678996, who can take part
- Record updated
- 1 July 2026