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

Not Applicable

Completed

• Conditions: Pain, Joint; Knee Osteoarthritis
• Interventions: Other: Whole-Body Vibration; Other: Exercise

• Registration Number: NCT06183177
• Lead Sponsor: Chinese University of Hong Kong

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-26
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-26
• Last Update Submitted: 2023-12-26
• Study First Posted: 2023-12-27
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise + WBV Group	Exercise	-
Exercise + WBV Group	Whole-Body Vibration	-
Exercise Group	Exercise	-

Primary Outcome Measures

Name	Time	Method
Range of motion (ROM) of the diseased knee	Baseline, 8 weeks	Measure the angle of knee bending from straight (0 degree) to fully bended (180 degrees)
Knee Society Functional Assessment	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	Baseline, 8 weeks	Pain assessment. Minimum value = 0, Maximum value = 10; the higher the score the worse the pain level
Gait analysis	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
Knee Society Score	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 Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score (KOOS)-Other Symptoms (S)	Baseline, 8 weeks	Score 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 weeks	Score 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 weeks	Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Functional reach test	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
Knee injury and Osteoarthritis Outcome Score (KOOS)-Sport and Recreation function	Baseline, 8 weeks	Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.
Timed Up and Go test	Baseline, 8 weeks	Score from 1 to 5. 1 indicates "normal function" and 5 indicates "severely abnormal function"
30-sec chair stand test	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.
Knee injury and Osteoarthritis Outcome Score (KOOS)-Knee pain (KP)	Baseline, 8 weeks	Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.

Trial Locations

Locations (1)

Michael.Ong@Cuhk.Edu.Hk; 🇭🇰 Hong Kong, NEW Territories, Hong Kong