Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Quadriceps strengthening
Sponsored by

About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Musculoskeletal diseases, Joint diseases
Eligibility Criteria
Inclusion Criteria:
- Pain in the knee
- Osteophytes on knee x-ray
- Self-reported pain on the inner aspect of the study knee
- Osteophytes in the medial compartment of the knee joint and
- Medial joint space narrowing greater than lateral joint space narrowing on x-ray
Exclusion Criteria:
- Knee surgery within the previous 6 months
- History of lower limb joint replacements
- Systemic arthritic conditions such as rheumatic or psoriatic arthritis
- Valgus knee deformity (> 5º)
- Inability to walk without the use of walking aids
- Intending to start a lower limb strengthening program in the next 3 months
- Seeking or currently receiving physiotherapy for OA knee
Sites / Locations
- The University of Melbourne
Outcomes
Primary Outcome Measures
Adduction moment
Time points: 0 and 13 weeks
Secondary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Numerical rating scales for pain
Quadriceps and hamstrings strength
Self-selected walking speed
Dynamic balance using step test
Physical function using stair climb test
Time points: 0 and 13 weeks
Full Information
NCT ID
NCT00414557
First Posted
December 20, 2006
Last Updated
December 21, 2006
Sponsor
University of Melbourne
Collaborators
Australian Physiotherapy Research Foundation, United Pacific Industries
1. Study Identification
Unique Protocol Identification Number
NCT00414557
Brief Title
Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis
Official Title
The Effects of Knee Malalignment and Quadriceps Strengthening on the Adduction Moment in Individuals With Medial Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Melbourne
Collaborators
Australian Physiotherapy Research Foundation, United Pacific Industries
4. Oversight
5. Study Description
Brief Summary
To investigate the effects of quadriceps strengthening on the adductor moment in individuals with medial knee OA and whether quadriceps strengthening has a different effect on the adductor moment in individuals with and without knee malalignment
Detailed Description
Although quadriceps strengthening is the cornerstone of physiotherapy management, recent evidence suggests that high quadriceps strength in patients with malaligned knees may increase OA progression.
This study investigates the effects of quadriceps strengthening on the adduction moment in patients with medial knee OA with and without malalignment. 107 participants with and without varus knee malalignment were recruited and randomised into an exercise or a control group. Participants in the exercise group were taught five quadriceps strengthening exercises by a project physiotherapist to be performed five days a week for twelve weeks at home. The exercises were:
Quadriceps exercise over fulcrum using ankle weight
Straight leg raise exercise using ankle weight
Long arc knee extension exercise in sitting using ankle weight
Knee extension exercise with isometric hold at 60° knee flexion using ankle weight
Knee extension exercise with isometric hold at 60° knee flexion using an elastic band.
Each exercise was performed at 2x10 repetitions for the first 2 weeks and 3x10 repetitions thereafter.
Participants visited the physiotherapist 7 times at Week 1, 2, 3, 4, 5, 7 and 10. They were given the ankle weights and elastic band to bring home and instructed about the repetitions and weights to use by the physiotherapist, who also checked and progressed their exercises. The average duration of the physiotherapy sessions was 30 minutes. To monitor compliance, each participant was given an exercise instructions sheet and kept a training diary to record the exercises they had done.
The control group received no intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Musculoskeletal diseases, Joint diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
107 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Quadriceps strengthening
Primary Outcome Measure Information:
Title
Adduction moment
Title
Time points: 0 and 13 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Title
Numerical rating scales for pain
Title
Quadriceps and hamstrings strength
Title
Self-selected walking speed
Title
Dynamic balance using step test
Title
Physical function using stair climb test
Title
Time points: 0 and 13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pain in the knee
Osteophytes on knee x-ray
Self-reported pain on the inner aspect of the study knee
Osteophytes in the medial compartment of the knee joint and
Medial joint space narrowing greater than lateral joint space narrowing on x-ray
Exclusion Criteria:
Knee surgery within the previous 6 months
History of lower limb joint replacements
Systemic arthritic conditions such as rheumatic or psoriatic arthritis
Valgus knee deformity (> 5º)
Inability to walk without the use of walking aids
Intending to start a lower limb strengthening program in the next 3 months
Seeking or currently receiving physiotherapy for OA knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Bennell, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rana Hinman, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tim Wrigley, MSc
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Boon W Lim, MSc
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leena Sharma, MD
Organizational Affiliation
Northwestern University Medical School, Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3040
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18576289
Citation
Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. doi: 10.1002/art.23823.
Results Reference
derived
Learn more about this trial
Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis
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