Knee OsteoarthritisNCT06183177
Pain Function and QOL Undergoing Whole-Body Vibration and Exercise in End-Stage Knee Osteoarthritis
A study testing Whole-Body Vibration and Exercise in people with Knee Osteoarthritis and Pain, Joint, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis, Pain, Joint
- What is being tested?
- Whole-Body Vibration and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2021to 26 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage knee osteoarthritis on queue for scheduling primary total knee replacement
- Completed 8-week course of physiotherapy program
Who cannot join
- TKR during the last 12 months
- Severe heart failure or neurological diseases affecting physical functions
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Whole-Body Vibration, Exercise
- Medical subject headings
- Osteoarthritis, Knee, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body VibrationOther
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
ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise + WBV Group | Experimental | Not described Receives: Other: Whole-Body Vibration; Other: Exercise |
| Exercise Group | Active comparator | Not described Receives: Other: Exercise |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale
Pain assessment. Minimum value = 0, Maximum value = 10; the higher the score the worse the pain level
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks
Secondary outcomes (8)
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.
Measured: Baseline, 8 weeks
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.
Measured: Baseline, 8 weeks
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.
Measured: Baseline, 8 weeks
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.
Measured: Baseline, 8 weeks
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.
Measured: Baseline, 8 weeks
Timed Up and Go test
Score from 1 to 5. 1 indicates "normal function" and 5 indicates "severely abnormal function"
Measured: 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.
Measured: 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
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 Oct 2021
- Primary completion1 Jan 2023
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183177
- Sponsor's protocol ID
- 2020.401
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06183177
- Acronym / sponsor ID
- 2020.401
- Conditions
- Knee Osteoarthritis, Pain, Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise + WBV Group | Experimental | Other: Whole-Body Vibration, Other: Exercise |
| Exercise Group | Active comparator | Other: Exercise |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with end-stage knee osteoarthritis on queue for scheduling primary total knee replacement
- Completed 8-week course of physiotherapy program
Key exclusion criteria (2 listed)
- TKR during the last 12 months
- Severe heart failure or neurological diseases affecting physical functions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-Body Vibration10 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 | Other | Exercise + WBV Group |
| ExerciseFour 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 | Other | Exercise + WBV Group, Exercise Group |
Primary outcome
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
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)
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
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.
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.
8 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)-Knee pain (KP)
Time frame: Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)-Other Symptoms (S)
Time frame: Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)- Activities of Daily Living (ADL)
Time frame: Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)-Sport and Recreation function
Time frame: Baseline, 8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)-knee-related Quality of Life (QOL)
Time frame: Baseline, 8 weeks
Timed Up and Go test
Time frame: Baseline, 8 weeks
30-sec chair stand test
Time frame: Baseline, 8 weeks
Functional reach test
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Vibration and Exercise in people with Knee Osteoarthritis and Pain, Joint, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (time frame: Baseline, 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.