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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06183177
Enrollment
517
Registered
2023-12-27
Start date
2021-10-01
Completion date
2023-01-26
Last updated
2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis, Pain, Joint

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

Interventions

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

OTHERExercise

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numerical pain rating scaleBaseline, 8 weeksPain assessment. Minimum value = 0, Maximum value = 10; the higher the score the worse the pain level
Range of motion (ROM) of the diseased kneeBaseline, 8 weeksMeasure the angle of knee bending from straight (0 degree) to fully bended (180 degrees)
Gait analysisBaseline, 8 weeksMeasure the movement of legs from point A to B, measure the distance in cm between steps walking on a flat surface
Knee Society ScoreBaseline, 8 weeksScore from 0 to 100. Lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Knee Society Functional AssessmentBaseline, 8 weeksScore from 0 to 100. Lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

Secondary

MeasureTime frameDescription
Timed Up and Go testBaseline, 8 weeksScore from 1 to 5. 1 indicates normal function and 5 indicates severely abnormal function
Knee injury and Osteoarthritis Outcome Score (KOOS)-Knee pain (KP)Baseline, 8 weeksScore from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Functional reach testBaseline, 8 weeksIn 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
30-sec chair stand testBaseline, 8 weeksScore as 3-tier categories. Below Average; Average; Above Average. Sex- and age range-specific. Below average indicates a high risk of falls.
Knee injury and Osteoarthritis Outcome Score (KOOS)-Other Symptoms (S)Baseline, 8 weeksScore from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Knee injury and Osteoarthritis Outcome Score (KOOS)- Activities of Daily Living (ADL)Baseline, 8 weeksScore from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Knee injury and Osteoarthritis Outcome Score (KOOS)-Sport and Recreation functionBaseline, 8 weeksScore from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Knee injury and Osteoarthritis Outcome Score (KOOS)-knee-related Quality of Life (QOL)Baseline, 8 weeksScore from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026