Combined Intra Articular Corticosteroid and Physiotherapeutic Exercise in Patients With Osteoarthritis of the Knee: A Random-ised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Knee pain
研究概览
简要总结
Osteoarthritis (OA) of the knee is a very common chronic joint disorder associated pain and disability. As no cure exists, management aims to reduce pain, improve function, and enhance quality of life. The recommended hierarchy of management should consist of exercise in first line, then the add-on of drugs if necessary, and ultimately, if necessary, surgery.
The effect size of exercise therapy is of the same magnitude as most pharmacological treatments but is often without adverse effects. Local pharmacological treatment of the afflicted knee joint is recommended by means of intra-articular injections of corticosteroids, which is considered as a standard medical treatment of knee OA and are included in established guidelines for management of knee OA. While the two treatment approaches have been investigated separately in numerous clinical trials, the efficacy of a combined pharmacological and non-pharmacological approach is not known, despite the high rank of such combined treatment approach on the recommended hierarchy of management.
The purpose of this study is to assess the effects of exercise therapy in combination with intra-articular corticosteroid injections on patient reported pain and function in patients with knee OA.
The hypothesis is that the combined treatment approach (exercise therapy preceded by intra-articular injection of corticosteroid) enhances the clinical outcome compared to exercise therapy preceded by a placebo injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40 years or above
- •clinical knee osteoarthritis verified by radiography
- •pain during level walking of at least 40 mm on a 0-100 mm visual analog scale
- •clinical signs of local inflammation
- •body mass index between 20 and 35
排除标准
- •Exercise therapy within 3 months
- •Intraarticular corticosteroid within 3 months
- •Counter indications to exercise
- •Counter indications to corticosteroid
- •pregnant or breast feeding
- •Auto immune disease
- •Planned surgery in the study period
- •significant cardiovascular disease
- •significant neuroloigal disease
- •significant psychiatric disease
- •regional pain syndromes (e.g. fibromyalgia)
- •spinal nerve root compression syndromes
研究组 & 干预措施
Intraarticular steroid + Exercise
Intra-articular corticosteroid treatment with subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
干预措施: Intraarticular steroid (Drug)
Intraarticular steroid + Exercise
Intra-articular corticosteroid treatment with subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
干预措施: Exercise therapy (Other)
Intraarticular saline+Exercise
Combined intra-articular saline injection and subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
干预措施: Intraarticular saline (Drug)
Intraarticular saline+Exercise
Combined intra-articular saline injection and subsequent exercise therapy. Exercise therapy is commenced 2 weeks after injection
干预措施: Exercise therapy (Other)
结局指标
主要结局
Knee pain
时间窗: Change from baseline to week 14
Self-reported pain assessed by the pain subdomain in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
次要结局
- Knee pain(Change from baseline to week 2 and week 26)
- Knee symptoms(Change from baseline to week 2, 14, and 26)
- Functional pain test(Change from baseline to week 14, and 26)
- Knee Muscle strength(Change from baseline to week 14, and 26)
- 6 minute walk distance(Change from baseline to week 14, and 26)
- Systemic markers of inflammation in blood(Change from baseline to week 14, and 26)
- MRI based inflammation(Change from baseline to week 14, and 26)
研究者
Henning Bliddal
Professor
Frederiksberg University Hospital