跳至主要内容
临床试验/NCT04038918
NCT04038918已完成不适用

The Effectiveness of Relaxation Exercises on Pain, Functional Outcomes and Muscle Strength in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial

Dokuz Eylul University2 个研究点 分布在 2 个国家目标入组 106 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
The Numeric Pain Rating Scale

研究概览

简要总结

The purpose of this study is to investigate the effectiveness of progressive muscle relaxation (PMR) exercise on pain, functional outcomes and muscle strength in patients with TKA. Seventy patients with TKA are going to randomly assigned to intervention group and control group.

详细描述

Total knee arthroplasty (TKA) is applied in end-stage osteoarthritis to reduce pain, improve functional ability, and provide greater health related quality of life. However, evidence showed that presence of severe pain, impaired functional outcomes and reduced muscle strength continue up to 6 to 12 month after surgery. Relaxation techniques such as progressive muscle relaxation exercise and rhythmic breathing have long been used in treating postoperative pain and for various health-related purposes. Although the number of studies that include relaxation techniques in treating postoperative pain is increasing, there isn't any study that investigate the effectiveness of progressive muscle relaxation exercise on pain, functional outcomes and muscle strength in patients with TKA.

The aim is to investigate the effectiveness of progressive muscle relaxation (PMR) exercise on pain, functional outcomes and muscle strength in patients with TKA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30 years older above
  • Preoperative diagnosis have to be knee osteoarthritis
  • Have a primary total knee arthroplasty
  • Able to understand Turkish instructions
  • Willing and able to attend study

排除标准

  • Revision total knee arthroplasty
  • Unable to understand verbal and written instructions
  • Having previously orthopaedic or neurological disorder that causes gait disturbance

研究组 & 干预措施

Progressive Muscle Relaxation Exercise Group

Experimental

Standard postoperative physiotherapy program plus progressive muscle relaxation (PMR) exercise will be applied.

干预措施: progressive muscle relaxation exercise (Other)

Progressive Muscle Relaxation Exercise Group

Experimental

Standard postoperative physiotherapy program plus progressive muscle relaxation (PMR) exercise will be applied.

干预措施: standard postoperative physiotherapy program (Other)

Control Group

Other

Standard postoperative physiotherapy program will be applied.

干预措施: standard postoperative physiotherapy program (Other)

结局指标

主要结局

The Numeric Pain Rating Scale

时间窗: Postoperative three months

The Numeric Rating Scale (NPRS), reliable and valid instrument, is commonly used to determine for pain intensity in rehabilitation. The activity and resting pain level in the knee joints will be evaluated by NPRS from 0 to 10 (0 refers to no pain, 10 refers to worst pain).

Muscle Strength

时间窗: Postoperative three months

Strength of knee muscles will be evaluated by hand-held dynamometer.

Hospital for Special Surgery Knee Score

时间窗: Postoperative three months

Hospital for Special Surgery knee score. A scoring system evaluation of pain, mobility, range of motion and deforming of the knee giving 0-100 points.

Iowa Level of Assistance Scale

时间窗: Postoperative three months

This test assesses the patient's ability to perform four functional activities, namely, supine to sitting on the edge of the bed, sitting on the edge of the bed to standing, walking 4.57 meters. The scoring of these activities is done as independent 6 points, observational aid 5 points, minimum help 4 points, medium help 3 points, maximum help 2 points, fail 1 point and untested 0 points. Higher values represent a better outcome. Speed scoring is done by evaluating the walking speed at a distance of 13.4 meters (44 steps). 20 seconds (sec) and below are recorded as 0, 21-30 sec 1, 31-40 sec 2, 41-50 3, 51-60 sec 4, 61-70 sec 5 and 70 sec. Higher values represent a worse outcome

10 meter walk speed test

时间窗: Postoperative three months

10MWT testing distance require 5-m acceleration and 5-m deceleration space, with the inner 10-m zone being the distance over which gait is timed. Before the test, patients should be asked to walk as fast as possible and allowed to use assistive devices (cane, walker) if needed. Patients start to walk and accelerate in the 20-m. The stopwatch is started as soon as the patient's leg pass over the starting line and stopped the patient's leg pass over the 10-m sign.

Timed Up and Go (TUG)

时间窗: Postoperative three months

To determine fall risk and measure the progress of balance, sit to stand, and walking. The patient starts in a seated position. The patient stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device.

次要结局

  • 12-Item Short Form Survey(Postoperative three months)
  • Range of Motion(Postoperative three months)
  • Tampa Scale for Kinesiophobia (TSK)(Postoperative three months)
  • The Hospital Anxiety and Depression Scale (HADS)(Postoperative three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Musa Eymir

Research Assistant

Dokuz Eylul University

研究点 (2)

Loading locations...

相似试验