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临床试验/NCT02888795
NCT02888795已完成不适用

Identification of Early Response to Hypertonic Dextrose Prolotherapy Markers in Knee Osteoarthritis Patients by an Inflammation-related Cytokine Array

National Yang Ming Chiao Tung University Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年2月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Western Ontario McMaster University Osteoarthritis Index

研究概览

简要总结

Hypertonic dextrose prolotherapy has been used in knee osteoarthritis (OA) clinically for a long time. However the study about the mechanism is scant. The question of biomarkers of knee OA cartilage response to hypertonic dextrose prolotherapy remains currently unresolved. On this basis, the aim of this study was to characterize the secreted protein factors behind the inflammatory potential involving the hypertonic dextrose prolotherapy of knee OA.

10~12 older than 65 years old knee OA patients will be recruited for clinical Western Ontario McMaster University Osteoarthritis (WOMAC) index, knee X ray evaluation and knee joint synovial fluid analysis before and after hypertonic dextrose prolotherapy. The expressions of inflammatory factors will be measured by a novel cytokine antibody array methodology. The study will evaluate inflammation-related cytokines in patients of knee joint synovial fluid. Human Cytokine Antibody Array that allows profiling synovial fluid production of anti and pro-inflammatory cytokines simultaneously. Altered levels of cytokine from the array membranes incubated with tissue lysates will quantitatively depict as a histogram for relative cytokine induction or reduction in the synovial fluid. The cytokines messenger ribonucleic acid levels will be quantified by quantitative reverse-transcription polymerase chain reaction and proteins expression was analyzed by Enzyme-Linked ImmunoSorbent Assay. The WOMAC Index, minimum joint space width, and Human Cytokine Antibody Array between before and after interventions will be compared. Differences between groups will be determined by the Mann-Whitney U test. For the synovial angiogenesis is accompanied with inflammatory feature in knee OA, associations between endothelial growth factor (VEGF) expression and VEGF isoforms pattern will be determined with the Spearman correlation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 6 months of symptomatic knee OA
  • clinical criteria of moderate or moderate to severe knee OA ( the American Rheumatological Association grade II or III)

排除标准

  • severe knee OA (grade IV)
  • rheumatoid or other inflammatory arthritis
  • received physiotherapy, oral NSAIDs, corticosteroids or anticoagulant, during previous 2 weeks prior the treatment
  • received any knee intra-articular injections during previous one month prior the treatment
  • poorly controlled diabetes mellitus with fasting blood sugar greater than 200 mg/dL-
  • history of knee surgery
  • dementia or psychological disease.

研究组 & 干预措施

hypertonic dextrose prolotherapy

Experimental

干预措施: hypertonic dextrose prolotherapy (Drug)

结局指标

主要结局

Western Ontario McMaster University Osteoarthritis Index

时间窗: change from baseline at week 10

次要结局

  • protein array method for inflammatory factors(change from baseline at week 10)
  • standing knee X ray posterior-anterior view(change from baseline at week 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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