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Completed

NCT Number: NCT05967637

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.

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Key information

Conditions

Whole-body Vibration Arthropathy of Knee Edema Pathological Conditions, Signs and Symptoms Signs and Symptoms Swelling/ Edema

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sham-Whole body vibration

Other

The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.

Primary outcomes

  1. Baseline pain severity

    Time frame: baseline

    The pain severity will be evaluated using an NRS rating from 0 to 10, with 0 representing no pain and 10 representing maximal pain.

  2. Change in pain severity from baseline to day 5 after interventions

    Time frame: up to 5 days after baseline

    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.

  3. Change in the preoperative pain severity on the 7th day of surgery

    Time frame: up to 7 days after 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.

  4. Change in pain severity from day 7 to day 14 post-surgery

    Time frame: up to 14 days after 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.

  5. Change in pain severity from day 14 to day 21 post-surgery

    Time frame: up to 21 days after 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.

  6. Baseline leg circumference

    Time frame: baseline

    Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.

  7. Change in leg circumference from baseline to day 5 after interventions

    Time frame: up to 5 days after baseline

    Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.

  8. Change in the preoperative leg circumference on the 7th day of surgery

    Time frame: up to 7 days after surgery

    Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.

  9. Change in leg circumference from day 7 to day 14 post-surgery

    Time frame: up to 14 days after surgery

    Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.

  10. Change in leg circumference from day 14 to day 21 post-surgery

    Time frame: up to 21 days after surgery

    Knee swelling will be assessed by measuring the circumference of the mid-patella, thigh, and calf with the knee in full extension.

  11. Baseline range of motion

    Time frame: baseline

    The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.

  12. Change in range of motion from baseline to day 5 after interventions

    Time frame: up to 5 days after baseline

    The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.

  13. Change in the preoperative range of motion on the 7th day of surgery

    Time frame: up to 7 days after surgery

    The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.

  14. Change in range of motion from day 7 to day 14 post-surgery

    Time frame: up to 14 days after surgery

    The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.

  15. Change in range of motion from day 14 to day 21 post-surgery

    Time frame: up to 21 days after surgery

    The knee flexion and extension ranges of motion will be measured using a goniometer in the supine position.

  16. Baseline muscle strength

    Time frame: baseline

    Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.

  17. Change in muscle strength from baseline to day 5 after interventions

    Time frame: up to 5 days after baseline

    Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.

  18. Change in the preoperative muscle strength on the 7th day of surgery

    Time frame: up to 7 days after surgery

    Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.

  19. Change in muscle strength from day 7 to day 14 post-surgery

    Time frame: up to 14 days after surgery

    Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.

  20. Change in muscle strength from day 14 to day 21 post-surgery

    Time frame: up to 21 days after surgery

    Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.

  21. Baseline skin temperature

    Time frame: baseline

    A portable infrared thermometer will be used to measure knee skin temperature.

  22. Change in skin temperature from baseline to day 5 after interventions

    Time frame: up to 5 days after baseline

    A portable infrared thermometer will be used to measure knee skin temperature.

  23. Change in the preoperative skin temperature on the 7th day of surgery

    Time frame: up to 7 days after surgery

    A portable infrared thermometer will be used to measure knee skin temperature.

  24. Change in skin temperature from day 7 to day 14 post-surgery

    Time frame: up to 14 days after surgery

    A portable infrared thermometer will be used to measure knee skin temperature.

  25. Change in skin temperature from day 14 to day 21 post-surgery

    Time frame: up to 21 days after surgery

    A portable infrared thermometer will be used to measure knee skin temperature.

  26. Baseline knee proprioception

    Time frame: baseline

    Active reposition test will be measured using a digital inclinometer device.

  27. Change in knee proprioception from baseline to day 5 after interventions

    Time frame: up to 5 days after baseline

    Active reposition test will be measured using a digital inclinometer device.

  28. Change in the preoperative knee proprioception on the 7th day of surgery

    Time frame: up to 7 days after surgery

    Active reposition test will be measured using a digital inclinometer device.

  29. Change in knee proprioception from day 7 to day 14 post-surgery

    Time frame: up to 14 days after surgery

    Active reposition test will be measured using a digital inclinometer device.

  30. Change in knee proprioception from day 14 to day 21 post-surgery

    Time frame: up to 21 days after surgery

    Active reposition test will be measured using a digital inclinometer device.

  31. Baseline Time Up and Go

    Time frame: baseline

    functional performance test

  32. Change in Time Up and Go from baseline to day 5 after interventions

    Time frame: up to 5 days after baseline

    functional performance test

  33. Change in the preoperative Time Up and Go on the 7th day of surgery

    Time frame: up to 7 days after surgery

    functional performance test

  34. Change in Time Up and Go from day 7 to day 14 post-surgery

    Time frame: up to 14 days after surgery

    functional performance test

  35. Change in Time Up and Go from day 14 to day 21 post-surgery

    Time frame: up to 21 days after surgery

    functional performance test

Secondary outcomes

  1. SF-36

    Time frame: baseline

    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.

  2. Change in the preoperative SF-36 on the 21st day of surgery

    Time frame: up to 21 days after 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.

  3. WOMAC

    Time frame: before interventions, 21st day after 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.

  4. Change in the preoperative WOMAC on the 21st day of surgery

    Time frame: up to 21 days after 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.

  5. Global Rating of Change Scales (GROC)

    Time frame: up to 21st day after surgery

    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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Collaborators

  • Gulhane Training and Research Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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