NCT01641874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_1 knee-osteoarthritis

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

2.5 years

First QC Date

July 10, 2012

Last Update Submit

September 10, 2015

Conditions

Knee Osteoarthritis

Keywords

KneeOsteoarthritisMcKenzie systemExerciseMechanical Diagnosis and TherapyDirectional preference

Outcome Measures

Primary Outcomes (1)

  • 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

    Change from Baseline in 3 months

Secondary Outcomes (2)

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    Baseline, 2 weeks, 3 months, 1 year

  • Intermittent and Constant Osteoarthritis Pain: Knee version (ICOAP)

    Baseline, 2 weeks, 3 months, 1 year

Study Arms (3)

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

Procedure: Exercise

Evidence based exercise

ACTIVE COMPARATOR

Quadriceps strengthening and advice on aerobic exercises will be given

Procedure: Evidence based exercise

No intervention

NO INTERVENTION

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

Interventions

ExercisePROCEDURE

Directional specific exercise

Also known as: Repeated end range exercise
Specific directional exercise
Evidence based exercisePROCEDURE

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

Also known as: step downs, resisted quadriceps, cycling, gym exercises
Evidence based exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N0M2A0, Canada

Location

Related Publications (1)

  • 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.

    PMID: 24450370DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Richard A Rosedale, BSc

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 17, 2012

Study Start

November 1, 2009

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

September 11, 2015

Record last verified: 2015-09

Locations

CA(1)