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Completed

NCT Number: NCT06183177

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

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

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Numerical pain rating scale

    Time frame: Baseline, 8 weeks

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

  2. Range of motion (ROM) of the diseased knee

    Time frame: Baseline, 8 weeks

    Measure the angle of knee bending from straight (0 degree) to fully bended (180 degrees)

  3. Gait analysis

    Time frame: 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

  4. Knee Society Score

    Time frame: 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.

  5. Knee Society Functional Assessment

    Time frame: 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 outcomes

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

    Time frame: Baseline, 8 weeks

    Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.

  2. Knee injury and Osteoarthritis Outcome Score (KOOS)-Other Symptoms (S)

    Time frame: Baseline, 8 weeks

    Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.

  3. Knee injury and Osteoarthritis Outcome Score (KOOS)- Activities of Daily Living (ADL)

    Time frame: Baseline, 8 weeks

    Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.

  4. Knee injury and Osteoarthritis Outcome Score (KOOS)-Sport and Recreation function

    Time frame: Baseline, 8 weeks

    Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.

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

    Time frame: Baseline, 8 weeks

    Score from 0 to 100. 0 representing extreme knee problems and 100 representing no knee problems.

  6. Timed Up and Go test

    Time frame: Baseline, 8 weeks

    Score from 1 to 5. 1 indicates "normal function" and 5 indicates "severely abnormal function"

  7. 30-sec chair stand test

    Time frame: 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.

  8. Functional reach test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2023
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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