Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis

August 24, 2021 updated by: The Hong Kong Polytechnic University

External Tibia Torsion and Passive Muscle Stiffness of Quadriceps as Two Important Contributors of Joint Loading During Walking in People With Knee Osteoarthritis

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 50-80
  2. having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3
  3. having medial knee pain on most days of the month
  4. having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking

Exclusion Criteria:

  1. having lateral tibiofemoral compartment osteophytes greater than the medial side.
  2. having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months
  3. having a systemic arthritic condition (e.g., rheumatoid arthritis)
  4. having a knee joint replacement or high tibial osteotomy in the past
  5. having any other muscular, joint or neurological condition influencing lower limb function
  6. unable to walk unaided
  7. having low back, hip, ankle or foot pain > 3 on numerical rating scale
  8. having a body mass index (BMI) >36 kg/ m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Six-week exercise including stretching, strengthening, endurance and gait modification
Comprehensive exercise program including strengthening, stretching, gait modification etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System
Time Frame: At baseline and one week after intervention
External knee moment in the frontal plane during early stance phase of walking
At baseline and one week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score
Time Frame: At baseline and one week after intervention
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.
At baseline and one week after intervention
Tibial Torsion as Assessed by X-ray Imaging
Time Frame: At baseline
The angle between tibial and femur in the transverse plane
At baseline
Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography
Time Frame: At baseline and one week after intervention
Young's modulus by ultrasound elastography
At baseline and one week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Siu Ngor Fu, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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