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| Name | Class |
|---|---|
| Istanbul University Research Fund | UNKNOWN |
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In this study, the effect of intra-articular HA injection therapy on pre- and post-treatment TNF-alpha and IL-1beta levels and methylation changes in blood and synovial fluid in patients with knee osteoarthritis will be determined and compared with the placebo group. In addition, the effects of HA injection on pain, functional status and quality of life will be evaluated and these effects will be related to changes in TNF-alpha and IL-1-beta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-articular hyaluronic acid injection group | Active Comparator |
| |
| Intra-articular saline injection group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid injections | Device | Intra-articular hyaluronic acid will be administered to 30 selected patients. Blood and synovial fluid samples will be collected before HA injection and 1 week after 3 sessions of HA injection with one week interval. Home exercise programme will be given. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood and synovial fluid TNF-alpha levels | Assessments will be made before and 1 week after treatment | |
| Blood and synovial fluid IL-1beta levels | Assessments will be made before and 1 week after treatment | |
| Blood and synovial fluid TNF-alpha methylation changes | Assessments will be made before and 1 week after treatment | |
| Blood and synovial fluid IL-1beta methylation changes | Assessments will be made before and 1 week after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS)-pain (activity, rest, night) | minimum value : 0 maximum value :10 Higher scores mean worse outcome. | Evaluations will be performed before and 1 month, 3 months and 6 months after treatment |
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC)- (pain, stiffness, physical function, total score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dicle Rotinda Özdaş Sevgin | Contact | +90 530-141-5940 | rotindaozdas95@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Istanbul Faculty of Medicine | Recruiting | 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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| Saline -- placebo comparator | Other | Intra-articular saline (SF) will be administered to 20 selected patients. Blood and synovial fluid samples will be collected before and 1 week after 3 session of salin injection with one week interval. Home exercise programme will be given. |
|
Minimum value: 0 maximum value : 96 Higher scores mean worse outcome |
| Evaluations will be performed before and 1 month, 3 months and 6 months after treatment |
| Lequesne Index (pain or discomfort, walking distance, GYA) | Minimum value : 0 maximum value: 24 higher scores mean worse outcome. | Evaluations will be performed before and 1 month, 3 months and 6 months after treatment |
| D012216 |
| Rheumatic Diseases |