Back to resultsMuscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring muscle tension, alignment, knee osteoarthritis, loading
Eligibility Criteria
Inclusion Criteria:
- Age between 50-80
- having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3
- having medial knee pain on most days of the month
- having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking
Exclusion Criteria:
- having lateral tibiofemoral compartment osteophytes greater than the medial side.
- having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months
- having a systemic arthritic condition (e.g., rheumatoid arthritis)
- having a knee joint replacement or high tibial osteotomy in the past
- having any other muscular, joint or neurological condition influencing lower limb function
- unable to walk unaided
- having low back, hip, ankle or foot pain > 3 on numerical rating scale
- having a body mass index (BMI) >36 kg/ m2
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
Six-week exercise including stretching, strengthening, endurance and gait modification
Outcomes
Primary Outcome Measures
Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System
External knee moment in the frontal plane during early stance phase of walking
Secondary Outcome Measures
Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score
Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome.
Tibial Torsion as Assessed by X-ray Imaging
The angle between tibial and femur in the transverse plane
Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography
Young's modulus by ultrasound elastography
Full Information
NCT ID
NCT03628508
First Posted
August 6, 2018
Last Updated
August 24, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
Queen Mary Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03628508
Brief Title
Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis
Official Title
External Tibia Torsion and Passive Muscle Stiffness of Quadriceps as Two Important Contributors of Joint Loading During Walking in People With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Queen Mary Hospital, Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies. This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
muscle tension, alignment, knee osteoarthritis, loading
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Six-week exercise including stretching, strengthening, endurance and gait modification
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Comprehensive exercise program including strengthening, stretching, gait modification etc.
Primary Outcome Measure Information:
Title
Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System
Description
External knee moment in the frontal plane during early stance phase of walking
Time Frame
At baseline and one week after intervention
Secondary Outcome Measure Information:
Title
Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score
Description
Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome.
Time Frame
At baseline and one week after intervention
Title
Tibial Torsion as Assessed by X-ray Imaging
Description
The angle between tibial and femur in the transverse plane
Time Frame
At baseline
Title
Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography
Description
Young's modulus by ultrasound elastography
Time Frame
At baseline and one week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 50-80
having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3
having medial knee pain on most days of the month
having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking
Exclusion Criteria:
having lateral tibiofemoral compartment osteophytes greater than the medial side.
having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months
having a systemic arthritic condition (e.g., rheumatoid arthritis)
having a knee joint replacement or high tibial osteotomy in the past
having any other muscular, joint or neurological condition influencing lower limb function
unable to walk unaided
having low back, hip, ankle or foot pain > 3 on numerical rating scale
having a body mass index (BMI) >36 kg/ m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siu Ngor Fu, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis
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