Effect of Prolotherapy in Knee Osteoarthritis: Clinical and Ultrasonographic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Pain, Stiffness and Physical function
研究概览
简要总结
Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: intra-articular injection and extra-articular injections of 25% dextrose. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .
Aim: Determine whether prolotherapy improves pain. stiffness and function of symptomatic knee osteoarthritis and determine ultrasonographic changes before and after prolotherapy.
详细描述
Sixty knees with primary knee osteoarthritis will be included in the study, clinical assessment will be done, then plain X-ray for the affected knee (s), followed by musculoskeletal ultrasound assessment will be done.
The intervention:
- a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done.
- extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose.
- Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals.
Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
the Assessor doing the musculoskeletal ultrasound will be masked to the radiographic grading of knee osteoarthritis, the clinical condition and the improvement following prolotgerapy.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III)
- •consent obtained
排除标准
- •Early Knee osteoarthritis (KL grade I)
- •Severe Knee osteoarthritis (KL grade IV)
- •Causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases.
- •received oral or systemic steroids 1 year prior to the procedure
- •received intra-articular steroids or hyaluronic acid 1 year prior to the procedure
- •BMI >45Kg/m2
- •poorly controlled diabetes mellitus, on anticoagulation therapy, history of cancer
研究组 & 干预措施
G1 patients receive prolotherapy
Intra and extra articular dextrose 25%
干预措施: Prolotherapy with 25% Dextrose (Drug)
结局指标
主要结局
Pain, Stiffness and Physical function
时间窗: 24 weeks after last injection
whether prolotherapy improves physical function by Western Ontario and McMaster University (WOMAC) index and VAS in patients with primary knee osteoarthritis
次要结局
- Safety and Tolerability(24 weeks after last injection)
- Cartilage thickness(24 weeks after last injection)
研究者
Yousra Hisham Abdel Fattah
Lecturer of Physical Medicine, Rheumatology and Rehabilitation
University of Alexandria