Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis index
研究概览
简要总结
Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability and Health.
详细描述
A total of 60 patients will be collected. The participants will be randomized into three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). The functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections.
Participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of knee osteoarthritis
- •can walk for 15 meters
- •Kellgren-Lawrence grade 2 or greater
- •can follow up for 6 months
排除标准
- •Major diseases will affect balance, such as stroke
- •infectious disease,
- •rheumatoid arthritis,
- •pregnancy or prepare to pregnant
- •received knee injections in the past 6 months
- •previous knee operation history
研究组 & 干预措施
Study group
triamcinolone plus hyruan injection
干预措施: Triamcinolone plus hyruan (Drug)
Experimental
vitagen plus hyruan injection
干预措施: vitagen plus hyruan (Drug)
Placebo
normal saline plus hyruan injection
干预措施: normal saline plus hyruan (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis index
时间窗: changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections
assess knee related performance, scores: 0-100, higher score indicates a worse outcome
次要结局
- physical functional performance-walking(changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections)
- physical functional performance-balance(changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections)
- physical functional performance-stairs climbing(changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections)
- physical functional performance-chair rising(changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections)
- Knee Injury and Osteoarthritis Outcome Score(changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections)