The McKenzie System's Derangement Classification in Osteoarthritic Knees: Efficacy of McKenzie Treatment Versus Evidence Based Care: A Randomised Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Four item pain intensity measure (P4)
研究概览
简要总结
The purpose of the study is to explore if a subgroup of people with osteoarthritic knees can be identified using the McKenzie System of Mechanical Diagnosis and Therapy.
In the spine this subgroup, termed derangement,has been shown to respond rapidly to specific directional exercises.
The trial will explore whether these derangements in the knee respond to specific exercises compared to a control group with no exercises and non-derangement knees given general exercises.
详细描述
The Mechanical Diagnosis and Therapy (MDT) approach has been extensively used to classify and treat patients with spinal pain. Studies have shown this approach to be valid, reliable and able to predict outcome. Although the approach has been used for extremity joints there is no research on using this approach to classify individuals presenting with knee osteoarthritis.
An assessment tool that could potentially identify a subgroup of patients who would experience dramatic and rapid improvement to conservative care would be valuable.
Patients with an "osteoarthritic knee" diagnosis will be recruited after a consultation with an orthopaedic surgeon. Patients who consent to participate will be randomized into an intervention group and a control group. Baseline self reported function and pain will be collected. The control group will continue as planned on the waiting list for either a follow up orthopaedic consultation or for knee surgery. The intervention group will be assessed by one of three McKenzie credentialed therapist over 3 assessment sessions. The therapist will classify the patients as either having a "derangement" or not. Those classified as a derangement will have 2-3 follow up sessions and will be given direction specific exercises consistent with the principles of the McKenzie System over 2 weeks. Those patients who were not classified as derangements will be given 2-3 sessions of evidenced based osteoarthritis treatment consisting of strengthening exercises and advice on aerobic fitness exercise. At 2 weeks both groups will have baseline measures reassessed and will be discharged. Follow-up by telephone at 3 months and 1 year will reassess functional and pain measures.
Due to the high prevalence of knee osteoarthritis and the associated economic burden on our health care system it is important to investigate if physiotherapists are able to predict who will respond to conservative therapy. Classifying individuals with knee osteoarthritis into rapid responders or non responders to short-term physiotherapy treatment will allow more expensive medical evaluation and intervention to be directed to appropriate patients and avoid unnecessary treatment for patients likely to recover from less costly therapy.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with knee osteoarthritis
- •Pain for longer than four months
- •Knee X-ray/CT/MRI showing osteoarthritic changes
- •Able to attend physiotherapy 2-3 times per week for 2 weeks
- •Able to participate in exercise based therapy
排除标准
- •Unable to provide informed consent
- •Unable to understand written or spoken English
- •Neurological conditions
研究组 & 干预措施
Specific directional exercise
During the assessment a specific exercise will be identified for this group. The exercise will consist of a repeated specific end range movement of the knee
干预措施: Exercise (Procedure)
Evidence based exercise
Quadriceps strengthening and advice on aerobic exercises will be given
干预措施: Evidence based exercise (Procedure)
No intervention
Patient waits on the surgeons waiting list for next appointment or for planned knee surgery
结局指标
主要结局
Four item pain intensity measure (P4)
时间窗: Change from Baseline in 3 months
Measure of pain at different times of day as well as with activity on an eleven point scale from zero to ten
次要结局
- Intermittent and Constant Osteoarthritis Pain: Knee version (ICOAP)(Baseline, 2 weeks, 3 months, 1 year)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 2 weeks, 3 months, 1 year)
研究者
Richard Rosedale
Physiotherapist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
