MedTrace Logo

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

NCT07678996 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

ozone injection

All patients allocated to the ozone intervention groups will receive a total of 3 sessions of intra-articular ozone injections, administered once a week for three consecutive weeks. For all three treatment groups, the injection volume will be 10 mL per session, while the ozone concentrations will vary according to the assigned group as Ozone 10 µg/mL + Exercise, Ozone 15 µg/mL + Exercise, and Ozone 20 µg/mL + Exercise.

BEHAVIORAL

Exercise

All participants across all four groups will be prescribed a structured home exercise program. This program includes joint range of motion (ROM) exercises; strengthening exercises (including quadriceps strengthening, hamstring strengthening, hip abductor strengthening, and seated calf raises); and flexibility exercises (including hamstring stretching, gastrocnemius-soleus stretching, and quadriceps stretching). The home program will be performed for 30 minutes per day, 5 days a week, throughout the 3-month study period. To improve patient adherence to exercise, patients will be provided with an exercise diary.

Sponsors & Collaborators

  • Kayseri City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-19
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678996 on ClinicalTrials.gov