Clinical trial NCT00414557: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Knee Osteoarthritis
Keywords: Musculoskeletal diseases
Joint diseases
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Australian Physiotherapy Research Foundation
name: United Pacific Industries
First posted: 2006-12-21
Enrollment: 107
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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:

1. Quadriceps exercise over fulcrum using ankle weight
2. Straight leg raise exercise using ankle weight
3. Long arc knee extension exercise in sitting using ankle weight
4. Knee extension exercise with isometric hold at 60° knee flexion using ankle weight
5. 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.

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

Primary outcomes:
measure: Adduction moment
measure: Time points: 0 and 13 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
measure: Numerical rating scales for pain
measure: Quadriceps and hamstrings strength
measure: Self-selected walking speed
measure: Dynamic balance using step test
measure: Physical function using stair climb test
measure: Time points: 0 and 13 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The University of Melbourne
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Kim Bennell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Melbourne
name: Rana Hinman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Melbourne
name: Tim Wrigley, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Melbourne
name: Boon W Lim, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University Medical School, Chicago
name: Leena Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.