Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients

Knee Osteoarthritis Clinical Trial

Official title:

Randomized Control Trial Investigating the Effectiveness of Vibration Therapy on Sarcopenia in Osteoarthritis Knee Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03880344
• Other study ID #: CUHK_2018.403
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: December 31, 2024

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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with connective tissue disorders or myositis condition
• Previous cases of alcoholism or drug abuse
• Pregnancy or breast feeding

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Sarcopenia

Intervention

Device:
• Vibration Therapy
Vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months + Normal Regular out-patient department physiotherapy

Combination Product:
• Physiotherapy
Physiotherapy as post-operative rehabilitation programme for 6 months.

Locations

Country	Name	City	State
Hong Kong	Department of Orthopaedics & Traumatology	Hong Kong

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	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.	Baseline Assessment
Primary	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.	Pre-Operative Assessment
Primary	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.	Post-Operative 6 weeks
Primary	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.	Post-Operative 6 months
Primary	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.	Post-Operative 12 months
Secondary	Whole body lean muscle mass	DXA measurement scan	Baseline Assessment
Secondary	Whole body lean muscle mass	DXA measurement scan	Pre-Operative Assessment
Secondary	Whole body lean muscle mass	DXA measurement scan	Post-Operative 6 months
Secondary	Muscle Biopsy	Types of muscle fibers and satellite cells as Assessed by Muscle Biopsy Assessment	Intra-Operatively
Secondary	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.	Baseline Assessment
Secondary	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.	Pre-Operative Assessment
Secondary	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.	Post-Operative 6 weeks
Secondary	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.	Post-Operative 6 months
Secondary	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.	Post-Operative 12 months
Secondary	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).	Baseline Assessment
Secondary	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).	Pre-Operative Assessment
Secondary	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).	Post-Operative 6 weeks
Secondary	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).	Post-Operative 6 months
Secondary	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.	Baseline Assessment
Secondary	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.	Pre-Operative Assessment
Secondary	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.	Post-Operative 6 weeks
Secondary	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.	Post-Operative 6 months
Secondary	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.	Baseline Assessment
Secondary	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.	Pre-Operative Assessment
Secondary	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.	Post-Operative 6 weeks
Secondary	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.	Post-Operative 6 months
Secondary	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.	Baseline Assessment
Secondary	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.	Pre-Operative Assessment
Secondary	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.	Post-Operative 6 weeks
Secondary	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.	Post-Operative 6 months
Secondary	Hand-grip Strength	Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.	Baseline Assessment
Secondary	Hand-grip Strength	Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.	Pre-Operative Assessment
Secondary	Hand-grip Strength	Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.	Post-Operative 6 weeks
Secondary	Hand-grip Strength	Average of 3 times hand-grip strength values measures by a hand dynamometer grip strength meter.	Post-Operative 6 months
Secondary	Gait Speed	6 meter timed walking gait test	Baseline Assessment
Secondary	Gait Speed	6 meter timed walking gait test	Pre-Operative Assessment
Secondary	Gait Speed	6 meter timed walking gait test	Post-Operative 6 weeks
Secondary	Gait Speed	6 meter timed walking gait test	Post-Operative 6 months