Investigation of the Effect of Hyaluronic Acid Injection on Tnf-Alpha and IL-1beta at DNA-Protein Level in Knee Osteoarthritis Patients and Comparison With Clinical Parameters: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood and synovial fluid TNF-alpha levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of knee osteoarthritis according to ACR (American College of Rheumatology) criteria
- •Knee pain for more than 3 months
- •Presence of knee pain resistant to conservative treatment for at least 3 months
- •To be between the ages of 45-75
- •Kellgren-Lawrence stage 2-3 gonarthrosis detected in the available knee direct radiographs of the patients
排除标准
- •Patients with KL stage 1 and 4 OA
- •Systematic diseases (severe cardiovascular disease, severe renal failure, severe hepatic failure, uncontrolled diabetes, cancer, immunosuppression, haematological diseases, systemic bone diseases)
- •Bleeding tendency (acquired or inherited) [lNR>2 in a patient on Coumadin],
- •Infection (systemic or local)
- •Secondary knee osteoarthritis (inflammatory joint disease, post-traumatic, post-infectious, etc.)
- •Major knee trauma within the last 1 year
- •History of total knee or hip arthroplasty within 1 year
- •Pregnancy
- •History of intra-articular injection within the last 6 months
- •Patients with Hb less than 11 g/dl and Plt less than 150.000
- •Presence of allergy to hyaluronic acid products
研究组 & 干预措施
Intra-articular hyaluronic acid injection group
干预措施: Hyaluronic Acid injections (Device)
Intra-articular saline injection group
干预措施: Saline -- placebo comparator (Other)
结局指标
主要结局
Blood and synovial fluid TNF-alpha levels
时间窗: Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta levels
时间窗: Assessments will be made before and 1 week after treatment
Blood and synovial fluid TNF-alpha methylation changes
时间窗: Assessments will be made before and 1 week after treatment
Blood and synovial fluid IL-1beta methylation changes
时间窗: Assessments will be made before and 1 week after treatment
次要结局
- Visual Analogue Scale (VAS)-pain (activity, rest, night)(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)(Evaluations will be performed before and 1 month, 3 months and 6 months after treatment)
- Lequesne Index (pain or discomfort, walking distance, GYA)(Evaluations will be performed before and 1 month, 3 months and 6 months after treatment)
研究者
Dicle Rotinda Ozdas Sevgin
Principal Investigator
Istanbul University