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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Active Comparator | The group received a 3-week intra-articular injection of 15 mg/ml ozone. |
|
| Control Group | Active Comparator | The group received a 1 ml intra-articular injection of betamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone - oxygen Therapy | Other | Ozone gas is a structurally unstable molecule that contains three oxygen atoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Pain Score | Pain status of the patients was questioned with a scale between 0-10 | 4 weeks after the first dose of treatment |
| Western Ontario and McMaster Universities Arthritis Index | 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 | 4 weeks after the first dose of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Pain Score | Pain status of the patients was questioned with a scale between 0-10 | 12 weeks after the first dose of treatment |
| Western Ontario and McMaster Universities Arthritis Index | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Corticosteroid | Other | 1 ml betamethasone |
|
| 12 weeks after the first dose of treatment |
| D012216 |
| Rheumatic Diseases |