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

Study 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

Official Title
-----------------
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

Conditions
-----------------
Knee Osteoarthritis, Pain, Joint

Intervention / Treatment
-----------------
* Other: Whole-Body Vibration
* Other: Exercise


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise + WBV Group<br> | Other: Whole-Body Vibration<br>* 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<br>Other: Exercise<br>* 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<br>|
| Active Comparator: Exercise Group<br> | Other: Exercise<br>* 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<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical pain rating scale | Pain assessment. Minimum value = 0, Maximum value = 10; the higher the score the worser the pain level | Baseline, 8 weeks | 
| Diseased ROM |  | Baseline, 8 weeks | 
| Gait |  | Baseline, 8 weeks | 
| Knee Society Score | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS-KP | Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems. | Baseline, 8 weeks | 
| KOOS-S | Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems. | Baseline, 8 weeks | 
| KOOS-ADL | Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems. | Baseline, 8 weeks | 
| KOOS-Sport/Rec | Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems. | Baseline, 8 weeks | 
| KOOS-QOL | Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems. | Baseline, 8 weeks | 
| Timed Up and Go test | Score from 1 to 5. 1 indicates normal function and 5 indicates severely abnormal function | Baseline, 8 weeks | 
| 30-sec chair stand test | 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 | 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 |