Additional Therapeutic Effects of Dextrose 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
- 106
- 试验地点
- 1
- 主要终点
- physical activity-stair climbing time
研究概览
简要总结
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined dextrose injection to patients with knee osteoarthritis.
详细描述
A total of 106 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid group and hyaluronic acid combined dextrose group.
The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid combined dextrose injection per week in three weeks.
The pain, physical activity, and functional performance 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 month after injection.
Subjects and the evaluator 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
- 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
hyaluronic acid combined dextrose group
Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
干预措施: dextrose (Drug)
hyaluronic acid combined dextrose group
Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
干预措施: hyaluronic acid (Device)
hyaluronic acid group
Hyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
干预措施: hyaluronic acid (Device)
结局指标
主要结局
physical activity-stair climbing time
时间窗: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
stairs climbing
physical activity-chair rising time
时间窗: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
chair rising
physical activity-on level walking time
时间窗: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
10 meter walking
次要结局
- functional performance(changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection)
- quality of life(changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection)
研究者
Ru-Lan Hsieh
Professor
Taipei Medical University