The Effect of Pain Management, Relaxation and Fall Training on Clinical Parameters in Total Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 50 and over
- •Participants indicated for unilateral or bilateral total knee arthoplasty
- •Individuals to be followed after surgery
排除标准
- •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
研究组 & 干预措施
Intervention Group
In this study, the intervention group will be given comprehensive training in addition to standard conservative follow-up (pain spasm pain cycle, pain does not always mean that there is a problem, tissue repair, fall prevention, lower extremity classical massage, muscle relaxation relaxation methods, respiratory control), while the control group will be followed only with conservative treatment applications (muscle strengthening, stretching). The applications will be performed with 10 repetitions each day.
干预措施: Rehabilitation (Other)
Control Group
The control group will not be trained. Only exercise brochure including muscle strengthening and stretching will be given.
干预措施: Rehabilitation (Other)
结局指标
主要结局
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Fatih Ozden
Assistant Professor
Muğla Sıtkı Koçman University