Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Visual Analogue Pain Scale (VAS)
研究概览
简要总结
Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of knee osteoarthritis (OA) compared to steroids and viscosupplementation.
Aims/objectives: The objective of this randomized, controlled, double-blinded, prospective study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in the nonsurgical management of symptomatic OA compared to injections with corticosteroids and viscosupplements.
详细描述
The purpose of this research study is to examine the effectiveness of intra-articular (inside the joint) ketorolac injection compared to injection with either corticosteroid or hyaluronic acid for the treatment of painful knee osteoarthritis. Patients will be randomly assigned to receive either ketorolac (a nonsteroidal anti-inflammatory drug, methylprednisolone (a steroid), hyaluronic acid (a substance that is naturally present in the human body).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief.
排除标准
- •Prior injections into the same knee within the past 6 months,
- •Pregnant and/or lactating women,
- •Inflammatory joint disease including rheumatoid or psoriatic arthritis,
- •Concurrent use of anti-rheumatic drugs,
- •Allergy or hypersensitivity to the study medications,
- •Patients on an active pain management contract,
- •Patients with insurance that requires pre-certification for any of the study drugs,
- •Inability to make own decisions regarding the informed consent,
- •Inability to read and/or understand English,
- •Patients who are unable to return for follow-up or be reached by phone.
研究组 & 干预措施
Ketorolac
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
干预措施: Ketorolac Tromethamine Injection (Drug)
Corticosteroid
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
干预措施: Methylprednisolone Acetate Injection (Drug)
Hyaluronic Acid
One knee injection of Hylan G-F 20 (Synvisc-One)
干预措施: Hylan G-F 20 (Drug)
结局指标
主要结局
Visual Analogue Pain Scale (VAS)
时间窗: 3 months post injection
average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection
次要结局
- Patient Satisfaction(3 and 6 months post injection)
- Non-routine Visits Due to Inadequate Pain Relief or Complications(3 months post injection)
- Cost of Intervention(3 months post injection)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(3 and 6 months post injection)
- Oxford Knee Questionnaire(3 and 6 months post injection)
- Koos, Jr. Knee Survey(3 and 6 months post injection)
- Visual Analogue Pain Scale (VAS)(6 months)