Effects of Intra-articular Hypertonic Dextrose and Hyaluronic Acid on Primary Knee Osteoarthritis: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The aim of this study is to compare the effectiveness of intra-articular hypertonic dextrose and hyaluronic acid in managing pain and improving function in patients with primary knee osteoarthritis (KOA). This study will guide us to treat primary KOA patients with dextrose prolotherapy instead of hyaluronic acid more effectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee OA diagnosis satisfying the American College of Rheumatology clinical and radiographic criteria, Kellgren-Lawrence grade of II and III determined by Postero-anterior knee radiograph.
- •Participants will have the ability to undergo 3 months of follow-up
- •Participants who will agree to avoid non-steroidal anti-inflammatory drugs during the research (acetaminophen will be prescribed for intractable pain)
排除标准
- •Participants who will give a self-reported history of knee surgery, fracture, or infection.
- •Kellgren-Lawrence grade IV KOA.
- •Participants on anticoagulants.
- •Participants who will have previous history of intra-articular knee injection of HA or prolotherapy within 6 months.
- •Participants who have malignant disease or secondary KOA.
- •Participants who will have a history of comorbid illness(es) like chronic heart failure, advanced COPD, end-stage renal failure, advanced liver disease and poorly controlled DM.
研究组 & 干预措施
Effects of intra-articular hypertonic dextrose and hyaluronic acid on primary knee ostosteoarthritis
To see the effectiveness of intra-articular hypertonic dextrose versus hyaluronic acid on primary knee OA
干预措施: prolotherapy solution of 20% dextrose (Drug)
Effects of intra-articular hypertonic dextrose and hyaluronic acid on primary knee ostosteoarthritis
To see the effectiveness of intra-articular hypertonic dextrose versus hyaluronic acid on primary knee OA
干预措施: Hyaluronic Acid (HA) (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Outcome 1: " VAS score at week 1", Outcome 2: "VAS score at week 4", Outcome 3: "VAS score at week 12",
VAS consisting of a 100mm long horizontal line, where 0 at one end indicates no pain and 100 at another end indicates worst pain. Number of participants will be assessed from baseline in pain scores on the Visual Analog Scale at 1, 4 and 12 weeks after treatment completion. Lower scores indicate better outcomes.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Outcome 1: " WOMAC score at week 1", Outcome 2: " WOMAC score at week 4", Outcome 3: " WOMAC score at week 12"
WOMAC is a questionnaire consisting of 24 items organized into 3 subscales like pain, stiffness and physical function that is used in patients with knee osteoarthritis. Total score ranges from 0 to 96, with higher scores indicating worse symptoms. Number of participants will be assessed from baseline on the WOMAC Scale at 1, 4 and 12 weeks after treatment completion. Lower scores indicate better outcomes.
次要结局
未报告次要终点
研究者
Raju Dey
Director
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh