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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06183177
• Other study ID #: 2020.401
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: January 26, 2023

Study information

• Verified date: December 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: January 26, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Joint

Intervention

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
• 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

Locations

Country	Name	City	State
Hong Kong	Michael.Ong@Cuhk.Edu.Hk	Hong Kong	NEW Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical pain rating scale	Pain assessment. Minimum value = 0, Maximum value = 10; the higher the score the worse the pain level	Baseline, 8 weeks
Primary	Range of motion (ROM) of the diseased knee	Measure the angle of knee bending from straight (0 degree) to fully bended (180 degrees)	Baseline, 8 weeks
Primary	Gait analysis	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
Primary	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
Primary	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	Knee injury and Osteoarthritis Outcome Score (KOOS)-Knee pain (KP)	Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.	Baseline, 8 weeks
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)-Other Symptoms (S)	Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.	Baseline, 8 weeks
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)- Activities of Daily Living (ADL)	Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.	Baseline, 8 weeks
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)-Sport and Recreation function	Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.	Baseline, 8 weeks
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)-knee-related Quality of Life (QOL)	Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.	Baseline, 8 weeks
Secondary	Timed Up and Go test	Score from 1 to 5. 1 indicates "normal function" and 5 indicates "severely abnormal function"	Baseline, 8 weeks
Secondary	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
Secondary	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