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

NCT06183177 | Completed DMC

• 1 other identifier: 2020.401
• Study Type: interventional
• Target: 517
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis; Pain, Joint

Outcome Measures

Primary Outcomes (5)

• Numerical pain rating scale

  Pain assessment. Minimum value = 0, Maximum value = 10; the higher the score the worse the pain level

  Baseline, 8 weeks

• 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

• 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

• 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 Outcomes (8)

• Knee injury and Osteoarthritis Outcome Score (KOOS)-Knee pain (KP)

  Baseline, 8 weeks

• 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)-Sport and Recreation function

  Baseline, 8 weeks

• Knee injury and Osteoarthritis Outcome Score (KOOS)-knee-related Quality of Life (QOL)

  Baseline, 8 weeks

Study Arms (3)

Exercise + WBV Group

EXPERIMENTAL

Other: Whole-Body Vibration; Other: Exercise

Exercise Group

ACTIVE COMPARATOR

Other: Exercise

Control Group

NO INTERVENTION

Interventions

Whole-Body Vibration OTHER

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 + WBV Group

Exercise OTHER

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

Exercise + WBV Group; Exercise Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Michael.Ong@Cuhk.Edu.Hk

Hong Kong, NEW Territories, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthralgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 27, 2023
• Study Start: October 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 26, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)