Whole-body VibrationNCT05967637
The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty
A study testing Whole body vibration in people with Whole-body Vibration and Arthropathy of Knee, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Whole-body Vibration, Arthropathy of Knee, Swelling/ Edema
- What is being tested?
- Whole body vibration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Whole-body Vibration, Arthropathy of Knee, Swelling/ Edema
- Being tested
- Whole body vibration, Sham-Whole body vibration
- Keywords
- whole-body vibration, total knee arthroplasty, swelling, edema
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibrationOther
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 vibrationOther
The sham-whole body vibration treatment will follow the same procedures with the vibration machine off.
| Study group | Role | What they receive |
|---|---|---|
| Whole-body vibration | Experimental | Standard patient education and exercise training + whole body vibration Receives: Other: Whole body vibration |
| Sham-whole-body vibration | Sham comparator | Standard patient education and exercise training + sham whole body vibration Receives: Other: Sham-Whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 21 days after surgery
Baseline skin temperature
A portable infrared thermometer will be used to measure knee skin temperature.
Measured: baseline
Change in skin temperature from baseline to day 5 after interventions
A portable infrared thermometer will be used to measure knee skin temperature.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 21 days after surgery
Baseline knee proprioception
Active reposition test will be measured using a digital inclinometer device.
Measured: baseline
Change in knee proprioception from baseline to day 5 after interventions
Active reposition test will be measured using a digital inclinometer device.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 21 days after surgery
Baseline Time Up and Go
functional performance test
Measured: baseline
Change in Time Up and Go from baseline to day 5 after interventions
functional performance test
Measured: up to 5 days after baseline
Change in the preoperative Time Up and Go on the 7th day of surgery
functional performance test
Measured: up to 7 days after surgery
Change in Time Up and Go from day 7 to day 14 post-surgery
functional performance test
Measured: up to 14 days after surgery
Change in Time Up and Go from day 14 to day 21 post-surgery
functional performance test
Measured: up to 21 days after surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 21st day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whole-body VibrationStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane Training and Research Hospital
- Responsible party
- Principal investigator, Sevim Beyza Ölmez, Gazi University
- Investigators
- Zeynep Hazar, Study director, Gazi UniversityCemil Yıldız, Study chair, Gulhane Training and Research HospitalSevim Beyza Ölmez, Principal investigator, Gazi UniversityBeyza Yazgan, Principal investigator, Gazi Universityİnci Ayaş, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967637
- Sponsor's protocol ID
- 2023-874
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05967637
- Acronym / sponsor ID
- 2023-874
- Conditions
- Whole-body Vibration, Arthropathy of Knee, Swelling/ Edema
- Keywords
- whole-body vibration, total knee arthroplasty, swelling, edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Gulhane Training and Research Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-body vibration | Experimental | Other: Whole body vibrationStandard patient education and exercise training + whole body vibration |
| Sham-whole-body vibration | Sham comparator | Other: Sham-Whole body vibrationStandard patient education and exercise training + sham whole body vibration |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body vibrationThe 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. | Other | Whole-body vibration |
| Sham-Whole body vibrationThe sham-whole body vibration treatment will follow the same procedures with the vibration machine off. | Other | Sham-whole-body vibration |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Baseline muscle strength
Time frame: baseline
Knee extensor muscle strength will be assessed using a hand-held dynamometer in the sitting position.
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.
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.
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.
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.
Baseline skin temperature
Time frame: baseline
A portable infrared thermometer will be used to measure knee skin temperature.
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.
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.
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.
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.
Baseline knee proprioception
Time frame: baseline
Active reposition test will be measured using a digital inclinometer device.
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.
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.
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.
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.
Baseline Time Up and Go
Time frame: baseline
functional performance test
Change in Time Up and Go from baseline to day 5 after interventions
Time frame: up to 5 days after baseline
functional performance test
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
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
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
5 secondary outcomes
SF-36
Time frame: baseline
Change in the preoperative SF-36 on the 21st day of surgery
Time frame: up to 21 days after surgery
WOMAC
Time frame: before interventions, 21st day after surgery
Change in the preoperative WOMAC on the 21st day of surgery
Time frame: up to 21 days after surgery
Global Rating of Change Scales (GROC)
Time frame: up to 21st day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Hazar study director
Gazi University
Cemil Yıldız study chair
Gulhane Training and Research Hospital
Sevim Beyza Ölmez principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration in people with Whole-body Vibration and Arthropathy of Knee, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline pain severity (time frame: baseline). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.