The study's objective is to investigate the effects of whole-body vibration therapy administered before surgery on various factors related to patients who undergo total knee arthroplasty. These factors include pain, swelling, skin temperature, normal joint movement, knee joint position sense, knee extensor muscle strength, functional status, and patient satisfaction.
The study will include participants aged 50-80 who are planning to undergo total knee arthroplasty. According to the sample size analysis, a total of 40 people will be included in this study. The enrolled participants will be randomly assigned to one of two parallel groups: the whole-body vibration group or the sham whole-body vibration group. Both groups will receive standard patient education and exercise training.The experimental group will receive whole-body vibration along with exercise on the whole-body vibration device, while the control group (sham group) will receive sham vibration on the same device. All participants will receive treatment for a total of 5 days, one session per day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
The vibration will be applied for 10 minutes (30 seconds rest, 30 seconds training, 10 reps) in total with a low frequency (20 HZ) and low amplitude (2mm). Participants will be asked to stand in a squatting position by semi-flexing (30°) their knees during the 30-second vibration period.
The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.
Gazi University
Ankara, Turkey (Türkiye)
Baseline pain severity
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Time frame: baseline
Change in pain severity from baseline to day 5 after interventions
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.pain and 10 representing maximal pain.
Time frame: up to 5 days after baseline
Change in the preoperative pain severity on the 7th day of surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Time frame: up to 7 days after surgery
Change in pain severity from day 7 to day 14 post-surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Time frame: up to 14 days after surgery
Change in pain severity from day 14 to day 21 post-surgery
The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.
Time frame: up to 21 days after surgery
Baseline leg circumference
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time frame: baseline
Change in leg circumference from baseline to day 5 after interventions
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
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Time frame: up to 5 days after baseline
Change in the preoperative leg circumference on the 7th day of surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time frame: up to 7 days after surgery
Change in leg circumference from day 7 to day 14 post-surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time frame: up to 14 days after surgery
Change in leg circumference from day 14 to day 21 post-surgery
Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.
Time frame: up to 21 days after surgery
Baseline range of motion
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time frame: baseline
Change in range of motion from baseline to day 5 after interventions
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time frame: up to 5 days after baseline
Change in the preoperative range of motion on the 7th day of surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time frame: up to 7 days after surgery
Change in range of motion from day 7 to day 14 post-surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time frame: up to 14 days after surgery
Change in range of motion from day 14 to day 21 post-surgery
The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.
Time frame: up to 21 days after surgery
Baseline muscle strength
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time frame: baseline
Change in muscle strength from baseline to day 5 after interventions
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time frame: up to 5 days after baseline
Change in the preoperative muscle strength on the 7th day of surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time frame: up to 7 days after surgery
Change in muscle strength from day 7 to day 14 post-surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time frame: up to 14 days after surgery
Change in muscle strength from day 14 to day 21 post-surgery
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
Time frame: up to 21 days after surgery
Baseline skin temperature
A portable infrared thermometer will be used to measure knee skin temperature.
Time frame: baseline
Change in skin temperature from baseline to day 5 after interventions
A portable infrared thermometer will be used to measure knee skin temperature.
Time frame: up to 5 days after baseline
Change in the preoperative skin temperature on the 7th day of surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Time frame: up to 7 days after surgery
Change in skin temperature from day 7 to day 14 post-surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Time frame: up to 14 days after surgery
Change in skin temperature from day 14 to day 21 post-surgery
A portable infrared thermometer will be used to measure knee skin temperature.
Time frame: up to 21 days after surgery
Baseline knee proprioception
Active reposition test will be measured using a digital inclinometer device.
Time frame: baseline
Change in knee proprioception from baseline to day 5 after interventions
Active reposition test will be measured using a digital inclinometer device.
Time frame: up to 5 days after baseline
Change in the preoperative knee proprioception on the 7th day of surgery
Active reposition test will be measured using a digital inclinometer device.
Time frame: up to 7 days after surgery
Change in knee proprioception from day 7 to day 14 post-surgery
Active reposition test will be measured using a digital inclinometer device.
Time frame: up to 14 days after surgery
Change in knee proprioception from day 14 to day 21 post-surgery
Active reposition test will be measured using a digital inclinometer device.
Time frame: up to 21 days after surgery
Baseline Time Up and Go
functional performance test
Time frame: baseline
Change in Time Up and Go from baseline to day 5 after interventions
functional performance test
Time frame: up to 5 days after baseline
Change in the preoperative Time Up and Go on the 7th day of surgery
functional performance test
Time frame: up to 7 days after surgery
Change in Time Up and Go from day 7 to day 14 post-surgery
functional performance test
Time frame: up to 14 days after surgery
Change in Time Up and Go from day 14 to day 21 post-surgery
functional performance test
Time frame: up to 21 days after surgery
SF-36
The 36-Item Short-Form Health Survey (SF-36) is a general scoring instrument used to provide a health profile comprised of eight scaled scores. Each scale is instantly turned into a 0-100 scale, allowing identification of the patient's physical and mental status. A higher score means a better result.
Time frame: baseline
Change in the preoperative SF-36 on the 21st day of surgery
The 36-Item Short-Form Health Survey (SF-36) is a general scoring instrument used to provide a health profile comprised of eight scaled scores. Each scale is instantly turned into a 0-100 scale, allowing identification of the patient's physical and mental status. A higher score means a better result.
Time frame: up to 21 days after surgery
WOMAC
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-report multidimensional questionnaire that assesses pain, stiffness, and physical functional disability. A higher score means a better result.
Time frame: before interventions, 21st day after surgery
Change in the preoperative WOMAC on the 21st day of surgery
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a disease-specific self-report multidimensional questionnaire that assesses pain, stiffness, and physical functional disability. A higher score means a better result.
Time frame: up to 21 days after surgery
Global Rating of Change Scales (GROC)
The GROC score, which has seven response options ranging from 'much worse' (a score of 0) to 'much better' (a score of six), will be used to determine the subject's perception of overall improvement.
Time frame: up to 21st day after surgery