Investigation of Oral Glucosamine Effects on Synovial Fluid Viscosity and Viscoelasticity in Osteoarthritis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Changes in synovial fluid viscosity and viscoelasticity compared to baseline
研究概览
简要总结
Osteoarthritis (OA) is the most common joint disease associated with aging. Although many patients take glucosamine supplements as a non-traditional treatment for osteoarthritis, the effectiveness of these supplements is questionable. This study will evaluate glucosamine therapy by directly analyzing two functions of joint fluid that are impaired by osteoarthritis - namely, the abilities to lubricate the joint and absorb shocks during activity. Joint fluid samples will be collected from subjects with knee osteoarthritis and analyzed on a device that simulates typical joint movements. After 3 months of glucosamine supplementation, samples will be collected again to detect potential improvements in joint fluid function.
详细描述
Background:
The effectiveness of glucosamine sulphate as a treatment for OA is still under debate. Most clinical trials evaluate the effectiveness of OA treatments by self-administered questionnaires about joint pain, stiffness and function (Lequesne Algofunctional Index, Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC).
Although OA has been shown to reduce the viscosity and viscoelasticity of synovial fluid, few studies have used these properties as objective outcome measures in the assessment of glucosamine therapy.
The purpose of this study is to investigate whether glucosamine sulphate oral supplements improve the viscous and viscoelastic properties of synovial fluid in osteoarthritis patients and to explore potential correlations between these properties and subjective assessments of joint pain and function.
Research Method:
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are between 30 and 85 years of age
- •are clinically diagnosed with moderate to severe knee OA
- •are recommended for synovial fluid aspiration
排除标准
- •are clinically diagnosed with inflammatory arthritis
- •had previous joint surgery in the study knee
- •had injection in the study knee within the past 12 months
- •have taken glucosamine and/or chondroitin supplements within the past 3 months
结局指标
主要结局
Changes in synovial fluid viscosity and viscoelasticity compared to baseline
时间窗: 3 months
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score(3 months)