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临床试验/NCT06190041
NCT06190041尚未招募不适用

Kinesiophobia in Patients With Chronic Low Back Pain: an Evaluation on Relevant Factors and Its Effects on Quality of Life

Fatih Sultan Mehmet Training and Research Hospital0 个研究点目标入组 200 人开始时间: 2024年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
Kinesiophobia in patients with chronic low back pain

研究概览

简要总结

Low back pain is an important health problem that is common in public and causes serious socio-economic losses. Low back pain that persists for more than 12 weeks is defined as chronic low back pain. The prognosis in patients with chronic low back pain is generally not good and it significantly affects the patient's daily living activities and workforce. In the clinical course of chronic low back pain, patients generally reduce some activities or avoid them altogether due to fear of pain or concern about worsening of the initial lesion. This fear is called "kinesiophobia", which is an important factor in the chronicity of low back pain and the resulting functional disabilities. Kinesiophobia causes loss of flexibility, decreased muscle performance, muscle wasting, and all of these lead to a decrease in social and physical activities, which perpetuates and aggravates the disability. The aim of this study is to determine the relationship between the frequency of kinesiophobia in chronic low back pain patients and age, gender, body mass index, educational status, occupation, pain intensity and disability, and to examine the effect of kinesiophobia on quality of life.

详细描述

Approximately 200 patients with chronic low back pain lasting ≥12 weeks between the ages of 18-75 who applied to the outpatient clinic will be included in the study. Demographic data of the patients such as age, gender, body mass index and occupation will be recorded. The pain intensity of the patients will be evaluated with the Visual Analog Scale (VAS), their disability with the Oswestry disability index, their kinesiophobia with the Tampo scale for kinesiophobia (TSK), and their quality of life with the SF 36 quality of life scale. TSK is a 17-question scale developed to measure the fear of movement/re-injury. The scale has four answer options rated on a Likert scale (1=Strongly Disagree, 2=Disagree, 3=Agree, 4=Strongly Agree). The total score varies between 17 and 68. Oswestry disability index will be used to measure the person's level of functional disability in individuals with low back pain. Oswestry disability index includes ten subheadings: severity of pain, personal care, lifting loads, walking, sitting, standing, sleeping, sexual life, social life and travel. Each question is given a score between 0 (no disability) and 5 (full disability). The total score varies between 0 (no disability) and 50 (full disability). As the total score increases, functional status worsens. SF-36 short form index will be used to measure quality of life. SF 36 Short form is a questionnaire that provides wide-angle measurement within the quality of life scales and has a generic criterion feature. It consists of 36 questions in 8 categories under the headings of physical function, physical role difficulty, social function, mental health, vitality, pain, emotional role difficulty and general health. The answers to the questions are added as positive and negative and the total score varies between 0 and 100. A high score indicates good health.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having mechanic lower back pain lasting more than 12 weeks
  • VAS score ≥4
  • Being between the ages of 18-75

排除标准

  • Having inflammatory lower back pain
  • Presence of oncological disease
  • Presence of infection
  • Presence of recent trauma and/or lumbar fracture affecting the lumbar spine
  • Presence of neurological disease that will affect movement
  • Presence of rheumatic disease

结局指标

主要结局

Kinesiophobia in patients with chronic low back pain

时间窗: 3 months

Kinesiophobia will be assessed using the Turkish version of the Tampa Scale for kinesiophobia (TSK). TSK is a 17-question scale developed to measure the fear of movement/re-injury. The scale has four answer options rated on a Likert scale (1=Strongly Disagree, 2=Disagree, 3=Agree, 4=Strongly Agree). The total score varies between 17 and 68.

Disability in patients with chronic low back pain

时间窗: 3 months

Oswestry disability index will be used to measure the person's level of functional disability in individuals with low back pain.Oswestry disability index is a test that measures the level of functional disability in individuals with low back pain. It includes ten subheadings: severity of pain, personal care, lifting loads, walking, sitting, standing, sleeping, sexual life, social life and travel. Each question is given a score between 0 (no disability) and 5 (full disability). The total score varies between 0 (no disability) and 50 (full disability). As the total score increases, functional status worsens.

Quality of life in patients with chronic low back pain

时间窗: 3 months

SF-36 short form index will be used to measure quality of life. SF 36 Short form is a questionnaire that provides wide-angle measurement within the quality of life scales and has a generic criterion feature. It consists of 36 questions in 8 categories under the headings of physical function, physical role difficulty, social function, mental health, vitality, pain, emotional role difficulty and general health. The answers to the questions are added as positive and negative and the total score varies between 0 and 100. A high score indicates good health.

次要结局

未报告次要终点

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duygu Karamanlıoğlu

Principal investigator

Fatih Sultan Mehmet Training and Research Hospital

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