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

NCT ID: NCT01641874

Last Updated: 2015-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-08-31

Brief Summary

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.

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: PROCEDURE

Directional specific exercise

Evidence based exercise

Quadriceps strengthening and advice on aerobic exercises will be given

Group Type: ACTIVE_COMPARATOR

Evidence based exercise

Intervention Type: PROCEDURE

Quadriceps exercises and advice on aerobic exercises. Exercises are based on current evidence for the best exercises for osteoarthritic knee

No intervention

Patient waits on the surgeons waiting list for next appointment or for planned knee surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Directional specific exercise

Intervention Type: PROCEDURE

Evidence based exercise

Quadriceps exercises and advice on aerobic exercises. Exercises are based on current evidence for the best exercises for osteoarthritic knee

Intervention Type: PROCEDURE

Other Intervention Names

Repeated end range exercise; step downs, resisted quadriceps, cycling, gym exercises

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Richard Rosedale

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard A Rosedale, BSc

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

References

Rosedale R, Rastogi R, May S, Chesworth BM, Filice F, Willis S, Howard J, Naudie D, Robbins SM. Efficacy of exercise intervention as determined by the McKenzie System of Mechanical Diagnosis and Therapy for knee osteoarthritis: a randomized controlled trial. J Orthop Sports Phys Ther. 2014 Mar;44(3):173-81, A1-6. doi: 10.2519/jospt.2014.4791. Epub 2014 Jan 22.

Reference Type: DERIVED

PMID: 24450370 (View on PubMed)

Other Identifiers

IMDTRF

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

16399E

Identifier Type: -

Identifier Source: org_study_id