Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Weekly mean of the 24h average pain scores
研究概览
简要总结
Intra-articular injection of corticosteroid and hyaluronic acid is a common treatment for osteoarthritis of the knee. As a treatment drug for patients with depression, duloxetine has been shown in many studies to effectively relieve the pain of osteoarthritis and improve the function of the knee joint. However, there is no evidence regarding the efficacy of Intra-articular injection of corticosteroid and hyaluronic acid combined with duloxetine for pain management in patients with knee osteoarthritis. The aim of the study was to test the hypothesis that Intra-articular injection of corticosteroid plus hyaluronic acid combined with duloxetine could achieve superior pain management effects to Intra-articular injection of corticosteroid plus hyaluronic acid alone in patients undergoing knee osteoarthritis pain.
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 (Outcomes Assessor)
盲法说明
This is a prospective, randomized, open-label blind endpoint (PROBE) study
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants meet American College of Rheumatology clinical and radiographic criteria for the diagnosis of knee osteoarthritis with knee pain [ pain for ≥14 days of each month for ≥3 months before study entry, with a mean score ≥4 on the 24-h average pain score (0-10) using the average of daily ratings before the trial]
- •Body mass index < 40 kg/m2
- •Radiographic criteria included Kellgren-Lawrence grade Ⅱ-III
- •Knee stability, no deformity, no lumbar spondylosis with radiculopathy.
- •Good cognition, and the ability to understand the study protocol and the agreement to participate.
排除标准
- •Inflammatory arthritis, autoimmune disorder, septic arthritis, or any other concomitant disease (such as liver and kidney disease)
- •Those who prior synovial fluid analysis indicative of a diagnosis other than osteoarthritis
- •Participants with contraindications to duloxetine (currently using monoamine oxidase inhibitors, poorly controlled angle-closure glaucoma), previous exposure to duloxetine, combined with other drugs acting on the central nervous system (such as benzodiazepines) and allergic to any of the medications used in this study.
- •With metabolic diseases or anticoagulation therapy
- •Participants who had received invasive treatments to the knee during the past 6 months; joint replacement of the knee at any time or current infection in the affected limb.
研究组 & 干预措施
Duloxetine combined with intra-articular injection
干预措施: Duloxetine (Drug)
Duloxetine combined with intra-articular injection
干预措施: intra-articular injection of corticosteroid and hyaluronic acid (Drug)
Intra-articular injection
干预措施: intra-articular injection of corticosteroid and hyaluronic acid (Drug)
结局指标
主要结局
Weekly mean of the 24h average pain scores
时间窗: Twenty-fourth weeks
Weekly mean of the 24h average pain scores in participants with osteoarthritis knee pain at the end of 24 weeks as reported in participants' diaries based on the 11-point Likert scale (an ordinal scale with 0 indicating 'no pain', and 10 indicating 'worst pain imaginable')
次要结局
- The Western Ontario and McMaster Universities Osteoarthritis Index(At weeks 1, 2, 4, 8, 16 and 24 post-injection)
- The response to treatment(At weeks 1, 2, 4, 8, 16 and 24 post-injection)
- The Brief Pain Inventory(At weeks 1, 2, 4, 8, 16 and 24 post-injection)
- The Patient Global Impression of Improvement Scale(At weeks 2, 4, 8, 16 and 24 post-injection)
- Hospital Anxiety and Depression Scale(At weeks 2, 4, 8, 16 and 24 post-injection)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital