Comparison of Varying Doses of Steroid for Intra-articular Knee Injections
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Numerical Pain Scale (NPS)
研究概览
简要总结
The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with BMI ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.
排除标准
- •BMI < 30 kg/m2
- •Uncontrolled diabetics with a hemoglobin A1c > 8%
- •No other treatment within the time frame of the study.
- •Patients that are undergoing physical therapy at the time of the study.
研究组 & 干预措施
Lower Dose Group
Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.
干预措施: Triamcinolone Acetonide Low Dose (Drug)
Standard Dose Group
Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria.
干预措施: Triamcinolone Acetonide Standard Dose (Drug)
结局指标
主要结局
Numerical Pain Scale (NPS)
时间窗: Baseline, 4 weeks, 12 weeks
The Numerical Pain Scale (NPS) uses a 0-10 point rating system in which the patient selects the number that describes their current pain level, where "0" represents "no pain" and "10" represents "the worst pain imaginable"
Knee Injury and Osteoarthritis Outcome score (KOOS)
时间窗: Baseline, 4 weeks, 12 weeks
The Knee Injury and Osteoarthritis Outcome is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
次要结局
未报告次要终点
研究者
Jeff P. Nadwodny
Assistant Professor of Family Medicine
Mayo Clinic