The Efficacy and Safety of Intra-articular Injections of 48 mg, 32 mg and 20 mg Linear Hyaluronic Acid in Patients With Knee Osteoarthritis: A Multicenter Randomized Single-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline activity pain score at 1-months, 3-months and 6-months
研究概览
简要总结
The aim of this prospective, randomized, controlled multi-centre study is to compare the effectiveness and safety of three and five injections of standard linear hyaluronic acid (HA) versus single HA injection in terms of pain intensity and functional status in patients with knee osteoarthritis.
详细描述
Osteoarthritis (OA) is the most common form of chronic joint disease. A treatment option for patients diagnosed with knee osteoarthritis is intra-articular hyaluronic acid therapy. In this prospective, randomized controlled, single blind, interventional study, a total of 90 patients with stage 2-3 knee osteoarthritis according to the kellgren lawrence classification who meet the eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the three groups using computer-generated random numbers. In the first group, 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions, in the second group 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions and in the third group 2.4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in a single sessions will be applied. Participants are going to evaluate before injection, at the 1-month follow-up, at the 3-month follow-up and 6-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change in pain, stiffness and physical function score, the change in the Timed Up and Go Test (TUG) time and the change in the patient's daily activities with the numerical global patient assessment scale.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral symptomatic knee pain for at least three months
- •Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
- •Functional ambulation scale stage 4-5
- •Being able to attend injection and control examinations
排除标准
- •Intra-articular knee injection within the last six months
- •History of severe trauma to the knee within the past six months
- •Concomitant severe meniscus or ligament injury, surgery applied to the knee area
- •Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
- •Having a bleeding disorder and / or using warfarin
- •Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
- •Presence of cardiac or systemic disease that may affect exercise
- •The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
- •Body Mass Index ≥35 kg / m²
- •Allergy to hyaluranic acid products
结局指标
主要结局
Change from baseline activity pain score at 1-months, 3-months and 6-months
时间窗: Baseline, 1-month, 3-month, 6-month
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
次要结局
- Change from baseline rest pain score at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
- Change from baseline night pain score at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
- Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
- Change from baseline functional balance at 1-months, 3-months and 6-months(Baseline, 1-month, 3-month, 6-month)
研究者
Selim Sezikli
MD, Sub-Investigator
Istanbul University