The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty

Arthropathy of Knee Clinical Trial

Official title:

The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967637
• Other study ID #: 2023-874
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: August 2023
• Source: Gazi University
• Contact: Sevim Beyza Olmez
• Phone: +90 312 216 26 21
• Email: sevimbeyzaolmez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. These factors include pain, swelling, skin temperature, normal joint movement, knee joint position sense, knee extensor muscle strength, functional status, and patient satisfaction.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Edema
• Joint Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Gazi University	Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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