Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Other: Ozone - oxygen TherapyOther: Corticosteroid
- Registration Number
- NCT06328270
- Lead Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Brief Summary
This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 40-85 years old,
- have experienced knee pain and/or limited joint range of motion for at least 6 months,
- have a diagnosis of KOA supported by radiographic imaging.
- patients had undergone knee joint surgery,
- had a history of previous intra-articular injections,
- had any rheumatological disease or malignancy,
- being pregnant,
- had pain radiating to the knee and leg.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Group Ozone - oxygen Therapy The group received a 3-week intra-articular injection of 15 mg/ml ozone. Control Group Corticosteroid The group received a 1 ml intra-articular injection of betamethasone
- Primary Outcome Measures
Name Time Method Visual Pain Score 4 weeks after the first dose of treatment Pain status of the patients was questioned with a scale between 0-10
Western Ontario and McMaster Universities Arthritis Index 4 weeks after the first dose of treatment The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:\[1\] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
- Secondary Outcome Measures
Name Time Method Western Ontario and McMaster Universities Arthritis Index 12 weeks after the first dose of treatment The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:\[1\] Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Visual Pain Score 12 weeks after the first dose of treatment Pain status of the patients was questioned with a scale between 0-10
Trial Locations
- Locations (1)
University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
🇹🇷Istanbul, Turkey