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
- 56
- 试验地点
- 1
- 主要终点
- Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index
研究概览
简要总结
Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.
详细描述
A total of 56 patients will be enrolled and randomized into two groups, including 3 times of triamcinolone combined hyaluronic acid injections group and 3 times of hyaluronic acid injections group.
The triamcinolone combined hyaluronic acid injections group will receive 3 times of triamcinolone combined hyaluronic acid injection per week in three weeks; the hyaluronic acid group will receive hyaluronic acid injection in three weeks.
Physical activities and functional performance will be evaluated at before injection, at after one week, one month, three months, and six months of completion of 3 times of injections.
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, 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
- 是
入选标准
- •knee osteoarthritis with Kellgren/Lawrence grade II or III
排除标准
- •who have neurological deficit, such as stroke who have implant in knee
研究组 & 干预措施
triamcinolone and hyaluronic acid group
combined triamcinolone (Triamcinolone 10 mg 1cc) and hyaluronic acid (2 cc) injections: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
干预措施: Triamcinolone (Drug)
triamcinolone and hyaluronic acid group
combined triamcinolone (Triamcinolone 10 mg 1cc) and hyaluronic acid (2 cc) injections: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
干预措施: Hyaluronic acid (Device)
hyaluronic acid group
hyaluronic acid (2cc) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined triamcinolone and hyaluronic acid injections to hyaluronic acid injections
干预措施: Hyaluronic acid (Device)
结局指标
主要结局
Functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: changes from baseline to at after one week, one month, three months, and six months of completion of injections
Western Ontario and McMaster Universities Osteoarthritis Index
次要结局
- 10 meter walk test(changes from baseline to at after one week, one month, three months, and six months of completion of injections)
- 5 times rapid chair rising test(changes from baseline to at after one week, one month, three months, and six months of completion of injections)
- Quality of life assessed with the Knee Injury and Osteoarthritis Outcome Score(changes from baseline to at after one week, one month, three months, and six months of completion of injections)
研究者
Ru-Lan Hsieh
Associate Professor
Taipei Medical University