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Dose-Response Effect of Intra-Articular Ozone in Knee Osteoarthritis: A Randomized Controlled Single-Blind Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Kayseri City Hospital
RECRUITING
Kayseri
Contact Information
Primary
Serhat Efdal Ozbek, MD
serhatefdal60@gmail.com
+905072387257
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 80
Treatments
Experimental: 10 µg Ozone + Exercise
10 mL of ozone injection at a concentration of 10 µg/mL + Home exercise program
Experimental: 15 µg Ozone + Exercise
10 mL of ozone injection at a concentration of 15 µg/mL + Home exercise program
Experimental: 20 µg Ozone + Exercise
10 mL of ozone injection at a concentration of 20 µg/mL + Home exercise program
Active_comparator: Exercise Alone
Home exercise program alone
Related Therapeutic Areas
Sponsors
Leads: Kayseri City Hospital

This content was sourced from clinicaltrials.gov

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