Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: a Double-blind, Randomized-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 double-blind, randomized controlled design to compare the immediate, short-term and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection of 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 two groups, including hyaluronic acid combined corticosteroid group and hyaluronic acid combined dextrose group. The balance, physical activity (10 meters normal and fast walk, up and downstairs, and 5 repeated chair-rising time, timed up and go test), functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score) will be evaluated. All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six months after injection. Subjects and evaluators will be both blinded to the group's classification during the whole course of study.
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, Investigator, 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-Lawerence grade 2 or greater than 2 can follow up for 6 months
排除标准
- •major diseases will affect balance, such as stroke, infectious diseases, rheumatoid arthritis, dizziness, or vertigo fractures malignance pregnancy or prepare to pregnant received knee injections in the past 6 months previous operation of knee joints
研究组 & 干预措施
steroid plus hyaluronic acid
steroid plus hyaluronic acid injection, one time per week, for 3 weeks
干预措施: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis (Drug)
dextrose plus hyaluronic acid
dextrose plus hyaluronic acid injection, one time per week, for 3 weeks
干预措施: compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis (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; score range: 0-100, higher scores mean a worse outcome
assess knee osteoarthritis related performance
次要结局
- Balance(changes of scores from baseling to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-4, higher scores mean a better outcome)
- physical functional performance-walking(change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections)
- physical functional performance-stairs climbing(change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections)
- Doppler resistance index(changes of scores from baseline to at one week after 1 time of injection and two weeks after 2 times of injection; the lower values indicate a low blood vessel resistance)
- physical functional performance-chair raising(change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections)
- physical functional performance-balance(change 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; score range 0-100, higher scores mean at better outcome)
研究者
Ru-Lan Hsieh
Professor, MD
Taipei Medical University