The Efficacy of PRP Combined With Leg Swing and Quadriceps Strengthening Exercise to Treat Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Objective. In this study, the investigators aimed to investigate the efficacy of combined a single platelet-rich plasma (PRP) and physical exercise (leg swing and quadriceps strengthening exercise) versus PRP and hyaluronic acid (HA) combination therapy. Methods. One hundred and six patients with grade Ⅱ-Ⅲ Knee osteoarthritis (KOA) according to the Kellgren-Lawrence classification were randomly divided into intra-articular injection of PRP combined with leg swing and quadriceps strengthening exercise (group A) and intra-articular combination injections of PRP and HA (group B). Patients in group A received twice intra-articular injection of PRP (2 ml, 2 weeks apart) and regular leg swing and quadriceps strengthening exercise for 3 months. Patients in group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks. The primary outcome measures were Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities (WOMAC) score. The second outcomes included single leg stance test (SLS) and functional activity by 2 minutes walking test (2MWT) and time up and go test (TUGT). All outcomes were evaluated at baseline and after 1,3,6, and 12 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged ≥ 45 years old;
- •KOA was diagnosed according to the American College of Rheumatology Classification Criteria;
- •patients with the Kellgren-Lawrence grade (K-L grade) for KOA of Ⅰ-Ⅲ;
- •a history of symptoms more than three month, and patients with independent mobility.
排除标准
- •lower limb axial deviation large than 5° (valgus and varus knee);
- •patients with diabetes mellitus, sever cardiovascular disease, immunosuppressive status, mental illness or other diseases than might affect the results;
- •injections or other invasive treatments into the lower extremities were used in the past three months;
- •patients willing to follow the doctor's recommendation for exercise training;
- •patients with previous knee fracture or malignancy;
- •patients with a previous history of hip or knee joint surgery;
- •patients participating in hip or knee muscle strengthening in the past 3 months;
- •patients did not complete the intervention strategies or regular follow-up.
研究组 & 干预措施
PRP combined with leg swing and quadriceps strengthening exercise
Group A received twice intra-articular injection of platelet-rich plasma (2 ml, 2 weeks apart) and regular leg swing and quadriceps strengthening exercise for three months.
干预措施: platelet-rich plasma (Drug)
intra-articular combination injections of PRP and HA
Group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks.
干预措施: platelet-rich plasma (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 12 months
Degree of knee pain during treatment
Western Ontario and McMaster Universities (WOMAC) score
时间窗: 12 months
Severity of knee osteoarthritis
次要结局
- single leg stance test (SLS)(12 months)
- 2 minutes walking test (2MWT)(12 months)
- time up and go test (TUGT)(12 months)