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Clinical Trials/NCT06183177
NCT06183177
Completed
Not Applicable

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

Chinese University of Hong Kong1 site in 1 country517 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Chinese University of Hong Kong
Enrollment
517
Locations
1
Primary Endpoint
Knee Society Functional Assessment
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
January 26, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Tim-Yun Michael ONG

Clinical Assistant Professor

Chinese University of Hong Kong

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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

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

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)

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.

Secondary Outcomes

  • Knee injury and Osteoarthritis Outcome Score (KOOS)-Other Symptoms (S)(Baseline, 8 weeks)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)- Activities of Daily Living (ADL)(Baseline, 8 weeks)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)-knee-related Quality of Life (QOL)(Baseline, 8 weeks)
  • Functional reach test(Baseline, 8 weeks)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)-Sport and Recreation function(Baseline, 8 weeks)
  • Timed Up and Go test(Baseline, 8 weeks)
  • 30-sec chair stand test(Baseline, 8 weeks)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)-Knee pain (KP)(Baseline, 8 weeks)

Study Sites (1)

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