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Clinical Trials/NCT06009341
NCT06009341
Completed
Not Applicable

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

Muğla Sıtkı Koçman University1 site in 1 country50 target enrollmentMay 19, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Arthroplasty
Sponsor
Muğla Sıtkı Koçman University
Enrollment
50
Locations
1
Primary Endpoint
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
Status
Completed
Last Updated
4 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 19, 2023
End Date
December 1, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Muğla Sıtkı Koçman University
Responsible Party
Principal Investigator
Principal Investigator

Fatih Ozden

Assistant Professor

Muğla Sıtkı Koçman University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Fear of Falling Avoidance Behavior Questionnaire (FFABQ)

Time Frame: Change from Baseline FFABQ at 12 weeks

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.

Knee Society Short Form (KSSF)

Time Frame: Change from Baseline KSSF at 12 weeks

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.

Pain Catastrophising Scale (PCS)

Time Frame: Change from Baseline PCS at 12 weeks

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.

Visual Analog Scale (VAS)

Time Frame: Change from Baseline VAS at 12 weeks

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).

Tampa Scale for Kinesiophobia (TSK)

Time Frame: Change from Baseline TSK at 12 weeks

The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.

EQ-5D-3L Quality of Life Scale

Time Frame: Change from Baseline EQ-5D-3L at 12 weeks

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".

Activity Specific Balance Confidence Scale (ABC)

Time Frame: Change from Baseline ABC at 12 weeks

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.

Study Sites (1)

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