Role of Dextrose Prolotherapy and Methyl Prednisolone Injections in Osteoarthritis Knee
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Osteoarthritis Index (WOMAC),
研究概览
简要总结
Damage of the articularcartilage and laxity of the joint lead to worsening of Osteoarthritis knee. Recently prolotherapy has beenshown to decrease looseness of joints and decrease degeneration of articularcartilage in knee arthritis. However, use of prolotherapy has not been rigorouslystudied in osteoarthritic knee. Only limited studies have been done in westerncountries. There is scarcity of literature inIndian Population. Considering this uncertainty in the use of Dextroseprolotherapy in OA, we propose to conduct this study to find out whetherinjection with Dextrose Prolotherapy improves knee symptoms in patients with OAKnee compared to intra-articular steroid injection. We hypothesize that prolotherapy injections for knee OA willbe equally or more beneficial to the patients than steroids. Thepurpose of this study is to determine whether injectionwith Dextrose Prolotherapy, in and around the knee, can decrease painand disability from knee osteoarthritis. Oursecondary objective is to determine if Dextrose Prolotherapy provide bettersymptom relief than intra-articular Steroid injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 40-65 years, who has 1.Persisting Knee Pain due to OA Knee (Grade II or III, according to radiological classification of knee OA defined by Kellgren and Lawrence) 2.Pain of at-least 40 mm on a 0-100mm VAS when asked “What is the average level of your Left/ Right knee pain over the last week?†3.Willing to participate in all assessment 4.If both knees involved, participants choose one or both knees to be treated.
排除标准
- •1.Severe OA Knee (Grade IV , according to Kellgren and Lawrence classification) 2.Inflammatory or post-infectious knee arthritis 3.History of prior knee replacement repair 4.Prior knee Prolotherapy 5.Prior fracture of the knee joint 6.Any Knee injection within 3 months 7.Daily use of opioid medication 8.Other chronic pain diagnoses 9.Diabetes mellitus 10.Body mass index (BMI) > 40 kg/m2 11.H/O Anticoagulation therapy 12.Pregnancy 13.Co-morbidity severe enough to prevent participation in the study protocol including at-home exercise or attendance at scheduled injection appointments.
结局指标
主要结局
Osteoarthritis Index (WOMAC),
时间窗: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 6 months
VAS Scale
时间窗: 6 months
Goniometric ROM of affected Knee
时间窗: 6 months
Western Ontario McMaster University
时间窗: 6 months
次要结局
- Injection procedure related pain (0, 2 days after injection)(Patient Satisfaction)
