Arthropathy of Knee Clinical Trial
Official title:
The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | October 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - Patients with advanced idiopathic knee OA and scheduled for unilateral total knee arthroplasty will be considered candidates for the present study and will be asked to participate Exclusion Criteria: - if they had undergone another hip or knee joint replacement in the previous year - if they had any medical condition in which exercise was contraindicated - if they had any disease that affected functional performance |
Country | Name | City | State |
---|---|---|---|
Turkey | Gazi University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Gazi University | Gulhane Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline | |
Primary | 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. | up to 5 days after baseline | |
Primary | 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. | up to 7 days after surgery | |
Primary | 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. | up to 14 days after surgery | |
Primary | 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. | up to 21 days after surgery | |
Primary | 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. | baseline | |
Primary | 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. | up to 5 days after baseline | |
Primary | 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. | up to 7 days after surgery | |
Primary | 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. | up to 14 days after surgery | |
Primary | 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. | up to 21 days after surgery | |
Primary | Baseline range of motion | The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position. | baseline | |
Primary | 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. | up to 5 days after baseline | |
Primary | 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. | up to 7 days after surgery | |
Primary | 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. | up to 14 days after surgery | |
Primary | 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. | up to 21 days after surgery | |
Primary | Baseline muscle strength | Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position. | baseline | |
Primary | 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. | up to 5 days after baseline | |
Primary | 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. | up to 7 days after surgery | |
Primary | 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. | up to 14 days after surgery | |
Primary | 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. | up to 21 days after surgery | |
Primary | Baseline skin temperature | A portable infrared thermometer will be used to measure knee skin temperature. | baseline | |
Primary | Change in skin temperature from baseline to day 5 after interventions | A portable infrared thermometer will be used to measure knee skin temperature. | up to 5 days after baseline | |
Primary | Change in the preoperative skin temperature on the 7th day of surgery | A portable infrared thermometer will be used to measure knee skin temperature. | up to 7 days after surgery | |
Primary | Change in skin temperature from day 7 to day 14 post-surgery | A portable infrared thermometer will be used to measure knee skin temperature. | up to 14 days after surgery | |
Primary | Change in skin temperature from day 14 to day 21 post-surgery | A portable infrared thermometer will be used to measure knee skin temperature. | up to 21 days after surgery | |
Primary | Baseline knee proprioception | Active reposition test will be measured using a digital inclinometer device. | baseline | |
Primary | Change in knee proprioception from baseline to day 5 after interventions | Active reposition test will be measured using a digital inclinometer device. | up to 5 days after baseline | |
Primary | Change in the preoperative knee proprioception on the 7th day of surgery | Active reposition test will be measured using a digital inclinometer device. | up to 7 days after surgery | |
Primary | Change in knee proprioception from day 7 to day 14 post-surgery | Active reposition test will be measured using a digital inclinometer device. | up to 14 days after surgery | |
Primary | Change in knee proprioception from day 14 to day 21 post-surgery | Active reposition test will be measured using a digital inclinometer device. | up to 21 days after surgery | |
Primary | Baseline Time Up and Go | functional performance test | baseline | |
Primary | Change in Time Up and Go from baseline to day 5 after interventions | functional performance test | up to 5 days after baseline | |
Primary | Change in the preoperative Time Up and Go on the 7th day of surgery | functional performance test | up to 7 days after surgery | |
Primary | Change in Time Up and Go from day 7 to day 14 post-surgery | functional performance test | up to 14 days after surgery | |
Primary | Change in Time Up and Go from day 14 to day 21 post-surgery | functional performance test | up to 21 days after surgery | |
Secondary | 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. | baseline | |
Secondary | 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. | up to 21 days after surgery | |
Secondary | 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. | before interventions, 21st day after surgery | |
Secondary | 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. | up to 21 days after surgery | |
Secondary | 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. | up to 21st day after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03940651 -
Cardiac and Renal Biomarkers in Arthroplasty Surgery
|
Phase 4 | |
Completed |
NCT05593341 -
Opioid Education in Total Knee Arthroplasty
|
N/A | |
Not yet recruiting |
NCT05290818 -
Total Versus Robotic Assisted Unicompartmental Knee Replacement
|
N/A | |
Withdrawn |
NCT04099355 -
Investigating the Effect of Dronabinol on Post-surgical Pain
|
Early Phase 1 | |
Recruiting |
NCT04924205 -
A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
|
N/A | |
Completed |
NCT05399043 -
Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation
|
N/A | |
Terminated |
NCT03185117 -
Opioid Consumption After Hospital Discharge in Orthopedic Surgery
|
||
Completed |
NCT04118023 -
7T MRI to Evaluate Cartilage Defects in the Knee
|
||
Terminated |
NCT03260699 -
Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)
|
N/A | |
Recruiting |
NCT03283878 -
Antibiotic Prophylaxis in Patients Undergoing Elective TKA- Multi-center Trial
|
Phase 4 | |
Completed |
NCT03133481 -
Adductor Canal Block Versus Femoral Nerve Block for Total Knee Arthroplasty
|
Phase 3 | |
Active, not recruiting |
NCT04684160 -
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
|
N/A | |
Completed |
NCT03282201 -
A Survey on Blood Transfusions in Major Artrhoplasty Operations
|
||
Recruiting |
NCT06259032 -
Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment
|
N/A | |
Completed |
NCT02928562 -
The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
|
N/A | |
Completed |
NCT04481711 -
Total Knee Arthroplasty and Clinical Findings
|
N/A | |
Recruiting |
NCT01135160 -
Evaluation of Weight Bearing After Total Hip and Knee Replacement
|
||
Completed |
NCT03921034 -
IPACK Nerve Block for Total Knee Arthroplasty
|
Phase 4 | |
Active, not recruiting |
NCT05248815 -
Muscle Strength and Total Knee Replacement
|
||
Not yet recruiting |
NCT06024161 -
Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties
|