Knee ArthropathyNCT03880344
Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients
A study testing Vibration Therapy and Physiotherapy in people with Knee Arthropathy and Osteoarthritis, Knee, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Osteoarthritis (OA) is one of the commonest chronic degenerative conditions affecting our aging population. It limits joint movement and causing disability in elderlies due to discordant symptoms such as pain and stiffness. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Arthropathy, Osteoarthritis, Knee, Knee Osteoarthritis
- What is being tested?
- Vibration Therapy and Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Jan 2020to 31 Dec 2024
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged over 45 with end stage knee OA
- Patient has been scheduled for TKR
- Able to comply with the assessments and has given oral and written consent
Who cannot join
- Patients with connective tissue disorders or myositis condition
- Previous cases of alcoholism or drug abuse
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Orthopaedics & Traumatology
Hong Kong
Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd, (852) 3505 2715, kevinho@cuhk.edu.hk
Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd
About this study
Official title: Randomized Control Trial Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients
Osteoarthritis (OA) is one of the commonest chronic degenerative conditions affecting our aging population. It limits joint movement and causing disability in elderlies due to discordant symptoms such as pain and stiffness. The prevalence of radiologic knee osteoarthritis increases in proportion to age, reaching an astounding 64.1% for patients whom are over 60 years of age. In addition the prevalence of symptomatic knee OA has been shown to be around 10% in people who are 60 years and older.
Read the detailed description
Patients with end stage OA often adopt a sedentary lifestyle causing mobility and functionality decline to avoid joint pain and stiffness. This dysfunctions a series of antioxidant response cascades which eventually leads to muscle atrophy of the knee. Notably, muscle atrophy and weakness (i.e. sarcopenia) often accompanies with OA. However the relationship between these symptoms and OA remains undefined and no strong consensus have been made thus far. Our ongoing longitudinal study on muscle strength and functionality which investigates the prevalence of sarcopenia in end stage OA patient's pre and post operation (Total Knee Replacement) have reflected that 24% with severe knee OA patients also suffered sarcopenia. In addition, these patients also showed a much slower recovery and longer length of stay in hospital after undergoing surgical operation.
The effect of clinical sarcopenia affects our locomotion system in the aging population. Weakness in patients and decline in muscle strength results in significant functional impairment are often seen in the cohort, leading to fragility, falls, fractures and disability.
Many authors have tried to explain the pathophysiology of sarcopenia in an attempt to link the disorder to a molecular or biochemical level in numerous literature. Satellite cells (a myogenic stem cell), Insulin like growth factor 1 (IGF-1) (an important mediator of muscle growth and regeneration affecting muscle function) and fast twitch muscle fibres are three major molecular composites that have been widely studied. Evidence have suggested the close relationship between them and muscle atrophy and weakness. However, these studies have either shown the results from an animal standpoint or they lack specificity and further research is necessary to confirm their role in patients suffering from sarcopenia.
Attempts have also been made to discover the most effective intervention to treat or even eliminate the chances of sarcopenia. Among these studies resistance exercises have been documented the most.
Evidence showed that progressive resistance and aerobic exercises are most beneficial for the prevention and treatment of sarcopenia. Resistant training that such as lifting weights, strength resistance bands, resistance machines has shown to improve protein synthesis in skeletal muscle cells leading to better muscle strength and mass, leading to muscle hypertrophy and promotes muscle power. Our previous knowledge transfer study on developing an aerobic exercise (i.e. Tai Chi Exercise) for end stage OA patients also showed similar positive effects in subjects, decreasing their pain and stiffness symptoms and limitations in physical activity. Though resistance exercise showed promising effects, are safe and strongly advised interventions based on documented and our previous study, the elderly populations often accompanies with other physical symptoms (such as back pain) and diminished fine motor skills that may limit their range of movement in these exercise regimes. In addition, resistive exercises are extremely technical and is essential to execute with proper form to avoid further injury; hence these exercises are unable to perform safely alone at home, making the intervention less autonomous.
Vibration therapy is a noninvasive biophysical modality and has been demonstrated in a number of studies showing multiple positive effects in terms of postural control, balancing ability, circulation and most importantly muscle strength. Two of our previous studies investigated the long term effects on muscle performance and bone quality in using low-magnitude high frequency vibration. Though the results showed that the treatment is an effective method in fall prevention by improving on both frontiers, these two studies' main subject focuses were on the elderly population as a whole. A study pivoting on subjects with co-existing diagnosis of sarcopenia and OA is crucial to investigate the effectiveness of this therapy method. Limited studies have shown positive effects of vibration therapy on osteoarthritis, however, these studies were limited to a single gender (i.e. females) or contained subject recruitment bias or assessment period of less than 6 months. A randomized control trial with a longer assessment period is essential to investigate the true effects of vibration therapy on knee OA patients.
- Conditions
- Knee Arthropathy, Osteoarthritis, Knee, Knee Osteoarthritis
- Being tested
- Vibration Therapy, Physiotherapy
- Keywords
- vibration therapy, Knee Osteoarthritis, Knee Arthropathy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration TherapyDevice
Vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months + Normal Regular out-patient department physiotherapy
PhysiotherapyCombination product
Physiotherapy as post-operative rehabilitation programme for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Vibration Therapy + Normal Out-Patient Physiotherapy | Experimental | Patients' randomized to this group will receive vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months. Regular out-patient department physiotherapy will also be given. They will be assessed 6 weeks and 6 months post operatively. Receives: Device: Vibration Therapy; Combination Product: Physiotherapy |
| Normal Out-Patient Department Physiotherapy | Active comparator | Patients randomized to this group will receive regular out-patient department physiotherapy postoperatively for 6 months. They will be assessed 6 weeks and 6 months post operatively. Receives: Combination Product: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Flexion/Extension Strength
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Measured: Baseline Assessment
Knee Flexion/Extension Strength
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Measured: Pre-Operative Assessment
Knee Flexion/Extension Strength
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Measured: Post-Operative 6 weeks
Knee Flexion/Extension Strength
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Measured: Post-Operative 6 months
Knee Flexion/Extension Strength
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Measured: Post-Operative 12 months
Secondary outcomes (33)
Whole body lean muscle mass
DXA measurement scan
Measured: Baseline Assessment
Whole body lean muscle mass
DXA measurement scan
Measured: Pre-Operative Assessment
Whole body lean muscle mass
DXA measurement scan
Measured: Post-Operative 6 months
Muscle Biopsy
Types of muscle fibers and satellite cells as Assessed by Muscle Biopsy Assessment
Measured: Intra-Operatively
Knee Functions measure by the Knee Society Score
Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.
Measured: Baseline Assessment
Knee Functions measure by the Knee Society Score
Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.
Measured: Pre-Operative Assessment
Knee Functions measure by the Knee Society Score
Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.
Measured: Post-Operative 6 weeks
Knee Functions measure by the Knee Society Score
Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.
Measured: Post-Operative 6 months
Knee Functions measure by the Knee Society Score
Physician will assess on the Visual Analog Scale in pain score (None to Severe), Flexion Contracture (None to >20°), Extension lag (None to 20°), Total Range of Flexion (0-5° to 121-125°), Alignment (0° to Over 15°), Antero-posterior stability (<5mm to 10+mm), Mediolateral stability (<5° to 15°). Patients will record individuals' satisfaction, functional activities, and expectations.
Measured: Post-Operative 12 months
Knee Function measures by 6 meter Timed Walking Gait Test
The 10 meter timed walking test is a well-established and documented test for assessment for gait speed in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6 meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).
Measured: Baseline Assessment
Knee Function measures by 6 meter Timed Walking Gait Test
The 10 meter timed walking test is a well-established and documented test for assessment for gait speed in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6 meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).
Measured: Pre-Operative Assessment
Knee Function measures by 6 meter Timed Walking Gait Test
The 10 meter timed walking test is a well-established and documented test for assessment for gait speed in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6 meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).
Measured: Post-Operative 6 weeks
Knee Function measures by 6 meter Timed Walking Gait Test
The 10 meter timed walking test is a well-established and documented test for assessment for gait speed in patients. However, due to space limitations and the exhaustive nature of the test for patients with OA, the 6 meter test has been documented to be a valid and reliable substitute. Patients will be asked to walk a straight line of 6 meters where the time taken to complete the distance will be measured. (<7.5 seconds is normal).
Measured: Post-Operative 6 months
SF-12
The 36-Item Short Form Health Survey (SF-12) will be used to measure the health related Quality of Life. The SF-12 has twelve questions ; the scores are weighted sums of the questions in each section. Scores range from 0 - 60. Lower scores = more disability, higher scores = less disability.
Measured: Baseline Assessment
SF-12
The 36-Item Short Form Health Survey (SF-12) will be used to measure the health related Quality of Life. The SF-12 has twelve questions ; the scores are weighted sums of the questions in each section. Scores range from 0 - 60. Lower scores = more disability, higher scores = less disability.
Measured: Pre-Operative Assessment
SF-12
The 36-Item Short Form Health Survey (SF-12) will be used to measure the health related Quality of Life. The SF-12 has twelve questions ; the scores are weighted sums of the questions in each section. Scores range from 0 - 60. Lower scores = more disability, higher scores = less disability.
Measured: Post-Operative 6 weeks
SF-12
The 36-Item Short Form Health Survey (SF-12) will be used to measure the health related Quality of Life. The SF-12 has twelve questions ; the scores are weighted sums of the questions in each section. Scores range from 0 - 60. Lower scores = more disability, higher scores = less disability.
Measured: Post-Operative 6 months
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC will be used as a self-administered health status measure in assessing pain, stiffness, and function in patients with OA of the hip or knee. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline Assessment
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC will be used as a self-administered health status measure in assessing pain, stiffness, and function in patients with OA of the hip or knee. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Pre-Operative Assessment
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC will be used as a self-administered health status measure in assessing pain, stiffness, and function in patients with OA of the hip or knee. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. With a scale ranges from 0 to 96. Lower scores = more disability, higher scores = less disability.
Measured: Post-Operative 6 weeks
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
The WOMAC will be used as a self-administered health status measure in assessing pain, stiffness, and function in patients with OA of the hip or knee. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. With a scale ranges from 0 to 96. Lower scores = more disability, higher scores = less disability.
Measured: Post-Operative 6 months
IPAQ
The 36-Item Short Form Health Survey (SF-12) will be used to measure health-related physical activity (PA) performance. With a scale ranges from 0 to 96. Lower scores = more disability, higher scores = less disability.
Measured: Baseline Assessment
IPAQ
The 36-Item Short Form Health Survey (SF-12) will be used to measure health-related physical activity (PA) performance. Score is expressed as MET-min per week: MET level x minutes of activity x events per week. Computed to fall into the category of: "Low", "Moderate" and "High" level of Physical Activity.
Measured: Pre-Operative Assessment
IPAQ
The 36-Item Short Form Health Survey (SF-12) will be used to measure health-related physical activity (PA) performance. Score is expressed as MET-min per week: MET level x minutes of activity x events per week. Computed to fall into the category of: "Low", "Moderate" and "High" level of Physical Activity.
Measured: Post-Operative 6 weeks
IPAQ
The 36-Item Short Form Health Survey (SF-12) will be used to measure health-related physical activity (PA) performance. Score is expressed as MET-min per week: MET level x minutes of activity x events per week. Computed to fall into the category of: "Low", "Moderate" and "High" level of Physical Activity.
Measured: Post-Operative 6 months
Hand-grip Strength
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Measured: Baseline Assessment
Hand-grip Strength
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Measured: Pre-Operative Assessment
Hand-grip Strength
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Measured: Post-Operative 6 weeks
Hand-grip Strength
Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.
Measured: Post-Operative 6 months
Gait Speed
6 meter timed walking gait test
Measured: Baseline Assessment
Gait Speed
6 meter timed walking gait test
Measured: Pre-Operative Assessment
Gait Speed
6 meter timed walking gait test
Measured: Post-Operative 6 weeks
Gait Speed
6 meter timed walking gait test
Measured: Post-Operative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start31 Jan 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ho Ki Wai, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880344
- Sponsor's protocol ID
- CUHK_2018.403
- Status last verified
- Dec 2023
- First submitted
- 6 Mar 2019
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients
- ClinicalTrials.gov ID
- NCT03880344
- Acronym / sponsor ID
- CUHK_2018.403
- Conditions
- Knee Arthropathy, Osteoarthritis, Knee, Knee Osteoarthritis
- Keywords
- vibration therapy, Knee Osteoarthritis, Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Mar 2019 (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.
Osteoarthritis (OA) is one of the commonest chronic degenerative conditions affecting our aging population. It limits joint movement and causing disability in elderlies due to discordant symptoms such as pain and stiffness. The prevalence of radiologic knee osteoarthritis increases in proportion to age, reaching an astounding 64.1% for patients whom are over 60 years of age. In addition the prevalence of symptomatic knee OA has been shown to be around 10% in people who are 60 years and older.
Detailed description
Patients with end stage OA often adopt a sedentary lifestyle causing mobility and functionality decline to avoid joint pain and stiffness. This dysfunctions a series of antioxidant response cascades which eventually leads to muscle atrophy of the knee. Notably, muscle atrophy and weakness (i.e. sarcopenia) often accompanies with OA. However the relationship between these symptoms and OA remains undefined and no strong consensus have been made thus far. Our ongoing longitudinal study on muscle strength and functionality which investigates the prevalence of sarcopenia in end stage OA patient's pre and post operation (Total Knee Replacement) have reflected that 24% with severe knee OA patients also suffered sarcopenia. In addition, these patients also showed a much slower recovery and longer length of stay in hospital after undergoing surgical operation.
The effect of clinical sarcopenia affects our locomotion system in the aging population. Weakness in patients and decline in muscle strength results in significant functional impairment are often seen in the cohort, leading to fragility, falls, fractures and disability.
Many authors have tried to explain the pathophysiology of sarcopenia in an attempt to link the disorder to a molecular or biochemical level in numerous literature. Satellite cells (a myogenic stem cell), Insulin like growth factor 1 (IGF-1) (an important mediator of muscle growth and regeneration affecting muscle function) and fast twitch muscle fibres are three major molecular composites that have been widely studied. Evidence have suggested the close relationship between them and muscle atrophy and weakness. However, these studies have either shown the results from an animal standpoint or they lack specificity and further research is necessary to confirm their role in patients suffering from sarcopenia.
Attempts have also been made to discover the most effective intervention to treat or even eliminate the chances of sarcopenia. Among these studies resistance exercises have been documented the most.
Evidence showed that progressive resistance and aerobic exercises are most beneficial for the prevention and treatment of sarcopenia. Resistant training that such as lifting weights, strength resistance bands, resistance machines has shown to improve protein synthesis in skeletal muscle cells leading to better muscle strength and mass, leading to muscle hypertrophy and promotes muscle power. Our previous knowledge transfer study on developing an aerobic exercise (i.e. Tai Chi Exercise) for end stage OA patients also showed similar positive effects in subjects, decreasing their pain and stiffness symptoms and limitations in physical activity. Though resistance exercise showed promising effects, are safe and strongly advised interventions based on documented and our previous study, the elderly populations often accompanies with other physical symptoms (such as back pain) and diminished fine motor skills that may limit their range of movement in these exercise regimes. In addition, resistive exercises are extremely technical and is essential to execute with proper form to avoid further injury; hence these exercises are unable to perform safely alone at home, making the intervention less autonomous.
Vibration therapy is a noninvasive biophysical modality and has been demonstrated in a number of studies showing multiple positive effects in terms of postural control, balancing ability, circulation and most importantly muscle strength. Two of our previous studies investigated the long term effects on muscle performance and bone quality in using low-magnitude high frequency vibration. Though the results showed that the treatment is an effective method in fall prevention by improving on both frontiers, these two studies' main subject focuses were on the elderly population as a whole. A study pivoting on subjects with co-existing diagnosis of sarcopenia and OA is crucial to investigate the effectiveness of this therapy method. Limited studies have shown positive effects of vibration therapy on osteoarthritis, however, these studies were limited to a single gender (i.e. females) or contained subject recruitment bias or assessment period of less than 6 months. A randomized control trial with a longer assessment period is essential to investigate the true effects of vibration therapy on knee OA patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration Therapy + Normal Out-Patient Physiotherapy | Experimental | Device: Vibration Therapy, Combination Product: PhysiotherapyPatients' randomized to this group will receive vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months. Regular out-patient department physiotherapy will also be given. They will be assessed 6 weeks and 6 months post operatively. |
| Normal Out-Patient Department Physiotherapy | Active comparator | Combination Product: PhysiotherapyPatients randomized to this group will receive regular out-patient department physiotherapy postoperatively for 6 months. They will be assessed 6 weeks and 6 months post operatively. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients aged over 45 with end stage knee OA
- Patient has been scheduled for TKR
- Able to comply with the assessments and has given oral and written consent
Key exclusion criteria (3 listed)
- Patients with connective tissue disorders or myositis condition
- Previous cases of alcoholism or drug abuse
- Pregnancy or breast feeding
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 |
|---|---|---|
| Vibration TherapyVibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months + Normal Regular out-patient department physiotherapy | Device | Vibration Therapy + Normal Out-Patient Physiotherapy |
| PhysiotherapyPhysiotherapy as post-operative rehabilitation programme for 6 months. | Combination product | Normal Out-Patient Department Physiotherapy, Vibration Therapy + Normal Out-Patient Physiotherapy |
Primary outcome
Knee Flexion/Extension Strength
Time frame: Baseline Assessment
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Knee Flexion/Extension Strength
Time frame: Pre-Operative Assessment
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Knee Flexion/Extension Strength
Time frame: Post-Operative 6 weeks
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Knee Flexion/Extension Strength
Time frame: Post-Operative 6 months
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
Knee Flexion/Extension Strength
Time frame: Post-Operative 12 months
Muscle strength on the quadriceps is measured by instructing the patient to perform an active knee flexion/extension movement in a sitting position with both feet free from ground, and the hip and knee joint flexed at 90%. The optimal isometric force of the knee flexion/extension movement are measured by the dynamometer attached at the malleoli level with a strap. The measurements (0 to 30 cm) will be taken at maximum force for three times.
33 secondary outcomes
Whole body lean muscle mass
Time frame: Baseline Assessment
Whole body lean muscle mass
Time frame: Pre-Operative Assessment
Whole body lean muscle mass
Time frame: Post-Operative 6 months
Muscle Biopsy
Time frame: Intra-Operatively
Knee Functions measure by the Knee Society Score
Time frame: Baseline Assessment
Knee Functions measure by the Knee Society Score
Time frame: Pre-Operative Assessment
Knee Functions measure by the Knee Society Score
Time frame: Post-Operative 6 weeks
Knee Functions measure by the Knee Society Score
Time frame: Post-Operative 6 months
Knee Functions measure by the Knee Society Score
Time frame: Post-Operative 12 months
Knee Function measures by 6 meter Timed Walking Gait Test
Time frame: Baseline Assessment
Knee Function measures by 6 meter Timed Walking Gait Test
Time frame: Pre-Operative Assessment
Knee Function measures by 6 meter Timed Walking Gait Test
Time frame: Post-Operative 6 weeks
Knee Function measures by 6 meter Timed Walking Gait Test
Time frame: Post-Operative 6 months
SF-12
Time frame: Baseline Assessment
SF-12
Time frame: Pre-Operative Assessment
SF-12
Time frame: Post-Operative 6 weeks
SF-12
Time frame: Post-Operative 6 months
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Baseline Assessment
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Pre-Operative Assessment
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Post-Operative 6 weeks
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time frame: Post-Operative 6 months
IPAQ
Time frame: Baseline Assessment
IPAQ
Time frame: Pre-Operative Assessment
IPAQ
Time frame: Post-Operative 6 weeks
IPAQ
Time frame: Post-Operative 6 months
Hand-grip Strength
Time frame: Baseline Assessment
Hand-grip Strength
Time frame: Pre-Operative Assessment
Hand-grip Strength
Time frame: Post-Operative 6 weeks
Hand-grip Strength
Time frame: Post-Operative 6 months
Gait Speed
Time frame: Baseline Assessment
Gait Speed
Time frame: Pre-Operative Assessment
Gait Speed
Time frame: Post-Operative 6 weeks
Gait Speed
Time frame: Post-Operative 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration Therapy and Physiotherapy in people with Knee Arthropathy and Osteoarthritis, Knee, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Flexion/Extension Strength (time frame: Baseline Assessment). 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 7 Dec 2023.