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| Name | Class |
|---|---|
| Gulhane Training and Research Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-body vibration | Experimental | Standard patient education and exercise training + whole body vibration |
|
| Sham-whole-body vibration | Sham Comparator | Standard patient education and exercise training + sham whole body vibration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body vibration | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in leg circumference from baseline to day 5 after interventions |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zeynep Hazar | Gazi University | Study Director |
| Cemil Yıldız | Gulhane Training and Research Hospital | Study Chair |
| Sevim Beyza Ölmez | Gazi University | Principal Investigator |
| Beyza Yazgan | Gazi University | Principal Investigator |
| Ä°nci AyaÅŸ | Gazi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University | Ankara | 06490 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham-Whole body vibration | Other | The sham-whole body vibration treatment will follow the same procedures with the vibration machine off. |
|
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 |
| 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 |
| 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 |
| 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 |
| Baseline range of motion | The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | up to 21 days after surgery |
| Baseline skin temperature | A portable infrared thermometer will be used to measure knee skin temperature. | baseline |
| 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 |
| 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 |
| 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 |
| 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 |
| Baseline knee proprioception | Active reposition test will be measured using a digital inclinometer device. | baseline |
| 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 |
| 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 |
| 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 |
| 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 |
| Baseline Time Up and Go | functional performance test | baseline |
| Change in Time Up and Go from baseline to day 5 after interventions | functional performance test | up to 5 days after baseline |
| Change in the preoperative Time Up and Go on the 7th day of surgery | functional performance test | up to 7 days after surgery |
| Change in Time Up and Go from day 7 to day 14 post-surgery | functional performance test | up to 14 days after surgery |
| Change in Time Up and Go from day 14 to day 21 post-surgery | functional performance test | up to 21 days after surgery |
| 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 |
| 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 |
| 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 |
| 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 |