Comparison of Effectiveness of Dextrose Prolotherapy Treatment With Different Concentrations in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Change in Visual Analog Scale (VAS)
研究概览
简要总结
In this study, the investigators aimed to compare the efficacy of %5, %10 and %20 concentration dextrose prolotherapy (DPT) treatments in patients with primary knee osteoarthritis (OA). In this prospective, randomized, controlled, single-blind study, 128 patients who met the inclusion criteria were recruited and divided into four groups. Thirty patients from each group completed the study. %5 DPT was applied to Group 1, %10 to Group 2, and %20 to Group 3 in combination with home exercise program and hotpack therapy. Group 4 was given home exercise program and hotpack therapy. Groups were evaluated with VAS (Visual Analog Scale), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), knee ROM (Range of Motion), and Timed up and go test (TUG) parameters. DPT groups were evaluated in terms of side effects.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-70 years,
- •Knee pain for more than three months,
- •Diagnosed with primary knee OA according to ACR clinical/radiological diagnostic criteria and Kellgren-Lawrence stage II-III.
排除标准
- •Total knee replacement
- •Rheumatological diseases, systemic infection, and malignancy
- •Pregnancy or breastfeeding
- •Taking a nonsteroidal anti-inflammatory drug (NSAID) in the last week, taking steroid drugs in the last month
- •Undergoing anticoagulant or immunosuppressive therapy
- •Knee injection in the last 6 months
结局指标
主要结局
Change in Visual Analog Scale (VAS)
时间窗: Pre-intervention, sixth week, twelfth week.
VAS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result.
Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
时间窗: Pre-intervention, sixth week, twelfth week.
WOMAC; It consists of three subcategories: pain, stiffness, and physical function difficulty. A score of 20 for pain, 8 for stiffness, 68 for physical function difficulty, and a total of 96 points can be obtained. An increase in the score is interpreted as more pain, stiffness and loss of function.
Change in Knee Joint Range of Motion
时间窗: Pre-intervention, sixth week, twelfth week.
Knee flexion in the prone position and knee extension in the supine position were measured actively and passively with a goniometer.
Change in The Timed "Up & Go" Test
时间窗: Pre-intervention, sixth week, twelfth week.
In this test, balance, walking speed and functional capacity are evaluated. Patients who complete the test in less than 10 seconds are considered independent.
次要结局
- Change in Short Form 36 (SF-36)(Pre-intervention, twelfth week.)
研究者
Muhammet Uğur ÖZTÜRK
Medical Doctor
Turkish League Against Rheumatism