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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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.
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.
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
RECRUITINGBlood and synovial fluid TNF-alpha levels
Time frame: Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta levels
Time frame: Assessments will be made before and 1 week after treatment
Blood and synovial fluid TNF-alpha methylation changes
Time frame: Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta methylation changes
Time frame: Assessments will be made before and 1 week after treatment
Visual Analogue Scale (VAS)-pain (activity, rest, night)
minimum value : 0 maximum value :10 Higher scores mean worse outcome.
Time frame: 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)
Minimum value: 0 maximum value : 96 Higher scores mean worse outcome
Time frame: 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.
Time frame: Evaluations will be performed before and 1 month, 3 months and 6 months after treatment
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