Comparative Efficacy of Two Platelet-Rich Plasma Treatments For Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change from baseline activity pain score at 1-months and 6-months
研究概览
简要总结
The aim of our study is to determine the effects of intra-articular Platelet-Rich Plasma (PRP) prepared with two different techniques on pain intensity, functional status, quality of life, functional balance and femoral cartilage thickness in patients with knee osteoarthritis.
详细描述
Osteoarthritis (OA) is the most common form of chronic joint disease. Platelet-Rich Plasma (PRP) is an injection therapy used to treat chronic, painful musculoskeletal conditions, including knee OA. In this prospective, randomized controlled, double blind, interventional study, out of 154 patients who applied to the physical medicine and rehabilitation department, 96 patients who met the eligibility criteria were divided into the pure PRP group without anticoagulant (n=32), amber PRP group (n=32), and saline group (n=32). A home exercise program for knee osteoarthritis will be provided to all three groups, and the program will be followed by weekly phone calls. During the follow-up period, patients will be asked to continue their current medical treatments and not to changes to their activities of daily living. Participants are going to be evaluated using visual analog scale (VAS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a numeric rating scale for quality of life (NRS) baseline and at 1, 3, and 6-month follow-up periods, time Up and Go (TUG) test at the baseline and at 3 and 6 months after treatment, and changes in femoral cartilage thickness by ultrasound measurement at the baseline and at 6 months after 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic symptomatic knee pain between the ages of 30 and 75 years
- •Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
- •The ability to walk independently
排除标准
- •Previous treatment with an autologous blood product or stem cell preparation
- •Severe knee effusion
- •Concomitant severe meniscus or ligament injury
- •Recent cancer or other tumors
- •History of knee surgery
- •Previous diagnosis of a neuromuscular, infectious, or inflammatory disease
- •Bleeding disorders and/or use of warfarin
- •Body mass index above 40 kg/m²
- •Cardiac or systemic diseases that could affect participation in the exercise program
研究组 & 干预措施
T-LAB / PRP KIT
In the second group (PRP2 group; amber PRP) prepared with T-LAB / PRP KIT in 3 sessions will be applied.
干预措施: Intra-articular T-LAB / PRP KIT injection (Other)
SALINE
In the third group (saline group), prepared with SALINE in 3 sessions will be applied.
干预措施: Intra-articular SALINE injection (Other)
结局指标
主要结局
Change from baseline activity pain score at 1-months and 6-months
时间窗: Baseline, 1-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 and 6-months(Baseline, 1-month, 6-month)
- Change from baseline night pain score at 1-months and 6-months(Baseline, 1-month, 6-month)
- Change from baseline pain, stiffness and physical function at 1-months and 6-months(Baseline, 1-month, 6-month)
- Change from baseline functional balance at 1-months and 6-months(Baseline, 1-month, 6-month)
- Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months(Baseline, 6-month)
研究者
Ekin Ilke Sen
MD, Sub-Investigator
Istanbul University