The McKenzie System With Arthritic Knees: Do Some Knees Respond to Specific Exercise More Than General or no Exercise

September 10, 2015 updated by: Richard Rosedale, Lawson Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N0M2A0
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unable to provide informed consent
  • Unable to understand written or spoken English
  • Neurological conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Exercise
Directional specific exercise
Other Names:
  • Repeated end range exercise
Active Comparator: Evidence based exercise
Quadriceps strengthening and advice on aerobic exercises will be given
Procedure: Evidence based exercise
Quadriceps exercises and advice on aerobic exercises. Exercises are based on current evidence for the best exercises for osteoarthritic knee
Other Names:
  • step downs, resisted quadriceps, cycling, gym exercises
No Intervention: No intervention
Patient waits on the surgeons waiting list for next appointment or for planned knee surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Four item pain intensity measure (P4)
Time Frame: 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
Change from Baseline in 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline, 2 weeks, 3 months, 1 year
Functional outcome measure specific for knee osteoarthritis with subscales of pain, symptoms, sport, function and quality of life
Baseline, 2 weeks, 3 months, 1 year
Intermittent and Constant Osteoarthritis Pain: Knee version (ICOAP)
Time Frame: Baseline, 2 weeks, 3 months, 1 year
Measures nature of pain i.e. constant versus intermittent on a 5 point scale
Baseline, 2 weeks, 3 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Richard A Rosedale, BSc, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16399E
  • IMDTRF (Other Grant/Funding Number: IMDTRF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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