Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Synovial Fluid Analysis (IL-8)
研究概览
简要总结
The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.
详细描述
Once consented, the patient is assigned to either Group A or Group B. Group A patients will receive standard treatment only and will not be prescribed a knee brace. Group B patients will receive standard treatment and the Bioskin Ten-7 knee brace. On Day 0, the patient will be assigned to one of the 2 groups using a 1:1 assignment. VAS, WOMAC, Oxford Knee Score, KOOS questionnaires will be administered and a sample of the patient's synovial fluid will be sent to labs for cytokine and cell count analysis. All patients will record use of NSAIDs and for Group B, the start and end time of brace use will be recorded. All patients will return in 8 weeks to assess efficacy of treatment. All patients will return their diaries, complete the same validated outcome measures as Day 0 and undergo a repeat synovial fluid analysis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis.
- •Must have telephone access.
排除标准
- 未提供
研究组 & 干预措施
Standard Treatment Only
Group A will receive standard treatment only such as NSAIDs and injections
干预措施: Standard treatment only (Drug)
Standard Treatment plus Bioskin Ten-7
Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.
干预措施: Standard treatment only (Drug)
Standard Treatment plus Bioskin Ten-7
Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace.
干预措施: Standard treatment plus Bioskin Ten-7 knee brace (Device)
结局指标
主要结局
Synovial Fluid Analysis (IL-8)
时间窗: Week 8 - day 0
Interleukine 8 in Synovial fluid analysis
Synovial Fluid Analysis (TNF-alpha)
时间窗: Week 8 - day 0
Tumor necrosis factor - alpha in Synovial fluid analysis
Synovial Fluid Analysis (MIP - 1alpha)
时间窗: Week 8 - day 0
Macrophage Inflammatory Proteins - 1alpha
Synovial Fluid Analysis (MCP - 1)
时间窗: Week 8 -day 0
Monocyte chemotactic protein-1 - 1
Oxford Knee Score
时间窗: Day 0 and Week 8
KOOS - Pain
时间窗: Week 8- Day 0
Value at 8 weeks - value at day 0
KOOS - Symptoms
时间窗: Week 8 - Day 0
Value at 8 weeks - value at day 0
KOOS - ADL
时间窗: week 8 - day 0
Value at 8 weeks - value at day 0
KOOS - Sport/Rec
时间窗: Week 8 - day 0
Value at 8 weeks - value at day 0
KOOS - QOL
时间窗: Week 8 - day 0
Value at 8 weeks - value at day 0
Synovial Fluid Analysis (IL-6)
时间窗: Week 8 - day 0
Interleukine 6 in Synovial fluid analysis
WOMAC
时间窗: Day 0 and Week 8
assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index
Visual Analog Scale
时间窗: Day 0 and Week 8
identifies pain level
次要结局
未报告次要终点