Knee OsteoarthritisPhase 1/2NCT01641874
The McKenzie System With Arthritic Knees: Do Some Knees Respond to Specific Exercise More Than General or no Exercise
A Phase 1/2 study testing Exercise and Evidence based exercise in people with Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise and Evidence based exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Aug 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- Unable to understand written or spoken English
- Neurological conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Exercise, Evidence based exercise
- Keywords
- Knee, Osteoarthritis, McKenzie system, Exercise, Mechanical Diagnosis and Therapy, Directional preference
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
Also called Repeated end range exercise
Directional specific exercise
Evidence based exerciseProcedure or surgery
Also called step downs, resisted quadriceps, cycling, gym exercises
Quadriceps exercises and advice on aerobic exercises. Exercises are based on current evidence for the best exercises for osteoarthritic knee
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Exercise |
| Evidence based exercise | Active comparator | Quadriceps strengthening and advice on aerobic exercises will be given Receives: Procedure: Evidence based exercise |
| No intervention | No intervention | Patient waits on the surgeons waiting list for next appointment or for planned knee surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Four item pain intensity measure (P4)
Measure of pain at different times of day as well as with activity on an eleven point scale from zero to ten
Measured: Change from Baseline in 3 months
Secondary outcomes (2)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Functional outcome measure specific for knee osteoarthritis with subscales of pain, symptoms, sport, function and quality of life
Measured: Baseline, 2 weeks, 3 months, 1 year
Intermittent and Constant Osteoarthritis Pain: Knee version (ICOAP)
Measures nature of pain i.e. constant versus intermittent on a 5 point scale
Measured: Baseline, 2 weeks, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Principal investigator, Richard Rosedale, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Richard A Rosedale, BSc, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641874
- Sponsor's protocol ID
- 16399E
- Other IDs
- IMDTRF
- Status last verified
- Sep 2015
- First submitted
- 10 Jul 2012
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24450370
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The McKenzie System's Derangement Classification in Osteoarthritic Knees: Efficacy of McKenzie Treatment Versus Evidence Based Care: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01641874
- Acronym / sponsor ID
- 16399E
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, McKenzie system, Exercise, Mechanical Diagnosis and Therapy, Directional preference
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Specific directional exercise | Experimental | Procedure: ExerciseDuring 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 |
| Evidence based exercise | Active comparator | Procedure: Evidence based exerciseQuadriceps strengthening and advice on aerobic exercises will be given |
| No intervention | No intervention | –Patient waits on the surgeons waiting list for next appointment or for planned knee surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Unable to understand written or spoken English
- Neurological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Repeated end range exerciseDirectional specific exercise | Procedure or surgery | Specific directional exercise |
| Evidence based exerciseAlso: step downs, resisted quadriceps, cycling, gym exercisesQuadriceps exercises and advice on aerobic exercises. Exercises are based on current evidence for the best exercises for osteoarthritic knee | Procedure or surgery | Evidence based exercise |
Primary outcome
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
2 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 2 weeks, 3 months, 1 year
Intermittent and Constant Osteoarthritis Pain: Knee version (ICOAP)
Time frame: Baseline, 2 weeks, 3 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
- Derived from this study: PubMed 24450370Rosedale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Rosedale, BSc principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exercise and Evidence based exercise in people with Knee Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Four item pain intensity measure (P4) (time frame: Change from Baseline in 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01641874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.