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临床试验/NCT01641874
NCT01641874已完成1 期

The McKenzie System's Derangement Classification in Osteoarthritic Knees: Efficacy of McKenzie Treatment Versus Evidence Based Care: A Randomised Controlled Trial

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2009年11月1日最近更新:
适应症
干预措施

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

Experimental

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

Active Comparator

Quadriceps strengthening and advice on aerobic exercises will be given

干预措施: Evidence based exercise (Procedure)

No intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Rosedale

Physiotherapist

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (1)

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