Pain Function and QOL Undergoing Whole-Body Vibration and Exercise in End-Stage Knee Osteoarthritis

December 26, 2023 updated by: Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong

Improving Pain, Function and Quality of Life in End-Stage Knee Osteoarthritis: A Prospective Cohort Study of Whole-Body Vibration and Exercise as Bridging Therapies for Total Knee Replacement

Knee osteoarthritis (KOA) is a chronic progressive disease that imparts substantial socioeconomic burden to society and healthcare systems. The prevalence of KOA has dramatically risen in recent decades due to consistent increases in life expectancy, and demand for joint replacement continues to rise. Total knee replacement is indicated for end-stage KOA, as it is very effective in terms of pain relief, improvement of function, and quality of life. However, the investigators will be facing an unsustainable joint replacement burden, with significant healthcare budget and health workforce implications. To alleviate this problem, different strategies including reinforce the importance of education and exercise are included; as previous studies showed that less than 40% of patients with KOA received non-pharmacological treatment, indicating that the uptake of evidence-based guidelines in clinical practice and rehabilitation is still suboptimal. Several literatures revealed that quadriceps and hamstrings strength exercise could effectively reduce pain. It has widely accepted that patients with end stage KOA will eventually pursue total knee replacement as the only viable option, and exercise has low efficacy in reduction of pain and disability in this group of patients. So, the investigators would like to know whether exercise therapy can help severe KOA patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

517

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
    • NEW Territories
      • Hong Kong, NEW Territories, Hong Kong
        • Michael.Ong@Cuhk.Edu.Hk

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with end-stage knee osteoarthritis on queue for scheduling primary total knee replacement
  • Completed 8-week course of physiotherapy program

Exclusion Criteria:

  • TKR during the last 12 months
  • Severe heart failure or neurological diseases affecting physical functions

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Active Comparator: Exercise Group
Other: Exercise
Four to five sessions of a physiotherapist-led exercise program with education talk (20 minutes), group exercises (30 minutes) and individual exercises (30 minutes) per week supplemented with home exercises
Experimental: Exercise + WBV Group
Other: Whole-Body Vibration
10 minutes of whole-body vibration when performing semi-squatting or forward lunges (12-16 Hz, varying intensity from low to high depending on patients' tolerance
Other: Exercise
Four to five sessions of a physiotherapist-led exercise program with education talk (20 minutes), group exercises (30 minutes) and individual exercises (30 minutes) per week supplemented with home exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score
Time Frame: Baseline, 8 weeks
Score from 0 to 100. Lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Baseline, 8 weeks
Knee Society Functional Assessment
Time Frame: Baseline, 8 weeks
Score from 0 to 100. Lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Baseline, 8 weeks
Numerical pain rating scale
Time Frame: Baseline, 8 weeks
Pain assessment. Minimum value = 0, Maximum value = 10; the higher the score the worse the pain level
Baseline, 8 weeks
Range of motion (ROM) of the diseased knee
Time Frame: Baseline, 8 weeks
Measure the angle of knee bending from straight (0 degree) to fully bended (180 degrees)
Baseline, 8 weeks
Gait analysis
Time Frame: Baseline, 8 weeks
Measure the movement of legs from point A to B, measure the distance in cm between steps walking on a flat surface
Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go test
Time Frame: Baseline, 8 weeks
Score from 1 to 5. 1 indicates "normal function" and 5 indicates "severely abnormal function"
Baseline, 8 weeks
30-sec chair stand test
Time Frame: Baseline, 8 weeks
Score as 3-tier categories. Below Average; Average; Above Average. Sex- and age range-specific. "Below average" indicates a high risk of falls.
Baseline, 8 weeks
Functional reach test
Time Frame: Baseline, 8 weeks
In standing, measures the distance between the length of an outstretched arm in a maximal forward reach; 10"/25 cm or greater: Low risk of falls; 6"/15cm to 10"/25cm: Risk of falling is 2x greater than normal; 6"/15cm or less: Risk of falling is 4x greater than normal; Unwilling to reach: Risk of falling is 8x greater than normal
Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)-Knee pain (KP)
Time Frame: Baseline, 8 weeks
Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)-Other Symptoms (S)
Time Frame: Baseline, 8 weeks
Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)- Activities of Daily Living (ADL)
Time Frame: Baseline, 8 weeks
Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)-Sport and Recreation function
Time Frame: Baseline, 8 weeks
Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)-knee-related Quality of Life (QOL)
Time Frame: Baseline, 8 weeks
Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Baseline, 8 weeks

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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)

October 1, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 26, 2023

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.401

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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