Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients

Knee Arthroplasty Clinical Trial

Official title:

The Effect of Pain Management, Relaxation and Fall Training on Clinical Parameters in Total Knee Arthroplasty Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009341
• Other study ID #: Artroplasti gevseme
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Mugla Sitki Koçman University
• Contact: Fatih Özden, PhD
• Phone: 543 433 4593
• Email: fatihozden[@]mu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the effectiveness of a comprehensive training program consisting of pain management, relaxation, breathing, massage and falling components will be investigated in patients with total knee arthroplasty. In this randomized controlled study, the trainings will be offered face-to-face after the initial evaluation and within the scope of telemedicine with prepared videos. The first evaluation will be performed on the first postoperative day and the last evaluation will be performed 3 months postoperatively. The aim of this study is to evaluate the effectiveness of a comprehensive education program consisting of pain management, relaxation, respiration, massage and fall components in patients with total knee arthroplasty.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: January 1, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Participants aged 50 and over
• Participants indicated for unilateral or bilateral total knee arthoplasty
• Individuals to be followed after surgery

Exclusion Criteria:

• Other surgeries
• Individuals with neurological and orthopedic diagnoses
• Individuals with cognitive, hearing, speech and psychiatric problems that prevent them from communicating
• Illiterate individuals
• Presence of malignancy
• Not signing the consent form

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Other:
• Rehabilitation
The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given. In addition, the intervention group will be taught the training program and applications.

Locations

Country	Name	City	State
Turkey	Mugla Sitki Koçman Training and Research Hospital	Mugla	Mentese

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Short Form (KSSF)	The scale is a 9-item measure developed to assess total knee arthroplasty patients' satisfaction, expectations, physical activities, and clinical and functional status in the preoperative and postoperative period, reported by both the physician and the patient.	Change from Baseline KSSF at 12 weeks
Primary	Visual Analog Scale (VAS)	On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).	Change from Baseline VAS at 12 weeks
Primary	Tampa Scale for Kinesiophobia (TSK)	The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.	Change from Baseline TSK at 12 weeks
Primary	EQ-5D-3L Quality of Life Scale	The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".	Change from Baseline EQ-5D-3L at 12 weeks
Primary	Pain Catastrophising Scale (PCS)	Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.	Change from Baseline PCS at 12 weeks
Primary	Activity Specific Balance Confidence Scale (ABC)	This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.	Change from Baseline ABC at 12 weeks
Primary	Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	The Fear of Falling Avoidance Behavior Questionnaire (FFABQ) was developed to assess avoidance behavior (activity limitation and participation restriction) in community-dwelling older adults. The FFABQ consists of 14 items ranked using a five-point Likert style, resulting in a maximum possible score of 56 points. A high score indicates activity limitation and participation restriction.	Change from Baseline FFABQ at 12 weeks