The Efficacy of Hyaluronic Acid Injection as an Adjunctive Treatment After Intraarticular Low-dose Glucocorticoid Injection for Symptomatic Knee Osteoarthritis: A Multicenter Randomized, Controlled, Double-blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Joint stiffness and function measurement
研究概览
简要总结
The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:
- Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis
- Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritis
Participants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.
Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo.
详细描述
Participants who had been diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria will be enrolled in this study. After the participants receive the information and consent to participate in this study, they will be examined their affected knee by the co-researchers. Ten-milligrams of Triamcinolone will be injected intra-articular into knee joint.
Two-to-four weeks later, the participants will be evaluated for knee pain, stiffness, function and quality of life, as well as knee performance status. Participants whose their knee joint absence of effusion will be allocated in to one treatment group; either Hyaluronic acid or normal saline. After injection, participants will be scheduled for the follow-up visit in 12 and 24 weeks later. In each follow-up visit, they will be evaluated for joint pain, stiffness, function and quality of life, as well as analgesic use and adverse reaction form treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will not know what treatment they receive. Co-investigators will not know what the participants are injected. Outcome assessor will not know which treatment participant receive.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants who had been diagnosed as knee osteoarthritis according to ACR criteria with symptom of knee pain
- •Pain visual analog scare of 4 or higher
排除标准
- •Participants who have
- •Cognitive impairment
- •History of aller to Hyaluronic acid or its component
- •History of knee arthropathy
- •Concomitant with inflammatory arthritis
- •Serious comorbidities or bedridden status
- •Current pregnancy or lactation
- •Currently use of symptomatic slow acting drugs for osteoarthritis (SYSADOA)
- •Communication problem
研究组 & 干预措施
Hyaluronic acid
Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection
干预措施: Sodium Hyaluronate (Drug)
Hyaluronic acid
Hyaluronic acid, Ostenil Plus, 2 mL (40 mg) will be injected once afer 2-4 week of glucocorticoid injection
干预措施: Triamcinolone Acetonide 10mg/mL (Drug)
Normal saline
Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection
干预措施: Normal Saline (Drug)
Normal saline
Two-millilitres of normal saline will be injected once after 2-4 weeks of glucocorticoid injection
干预措施: Triamcinolone Acetonide 10mg/mL (Drug)
结局指标
主要结局
Joint stiffness and function measurement
时间窗: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of joint stiffness and function after the injection, by using WOMAC scale (scale 0-10, which higher scale reflects worse symptom or function)
Pain outcome measurement
时间窗: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of joint pain after the injection, by using visual analog scale and pain domain assessment in Western Ontario and McMaster University (WOMAC) scale (scale 0-10, which higher scale reflects worse symptom)
Overall symptom assessment
时间窗: 12 and 24 weeks after injection
The comparison between Hyaluronic acid and normal saline injection in the change of overall symptom after the injection, by using patient's global assessment (scale 0-10, which higher scale reflects worse condition)
次要结局
- Quality of life assessment(12 and 24 weeks after injection)
- Knee performance evaluation(12 and 24 weeks after injection)