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临床试验/NCT06959355
NCT06959355已完成不适用

Examination of Frailty and Related Factors in Lumbar Spinal Stenosis

Karabuk University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2025年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
1
主要终点
Dynamic balance

研究概览

简要总结

Lumbar spinal stenosis (LSS) is generally seen with advanced age, but it manifests itself with an increase in both physical and psychological health problems. Frailty is an important parameter that has become increasingly important in recent years and affects both the physical and psychological health of individuals. It has been examined in various disease groups in the literature and is reported to increase in patients with low back pain. However, the level of frailty and related factors in LSS are unknown. Since physical and psychological health are important in maintaining daily life, it is important to examine frailty in these individuals who present with chronic pain symptoms.

详细描述

Lumbar spinal stenosis (LSS) is a degenerative disease that occurs due to compression of neurological structures as a result of narrowing of the spinal canal, and is particularly common in elderly individuals. LSS is characterized by pain, neurogenic claudication, decreased walking capacity, and functional disability. This condition can limit patients' daily living activities, leading to decreased physical activity levels, balance disorders, and increased fear of falling. At the same time, disability and decreased quality of life due to the disease can negatively affect individuals' physical and psychosocial health status, leading to increased frailty levels. Frailty is an important geriatric concept that requires multidisciplinary approaches and is associated with increased dependency and risk of falling in elderly individuals. Demonstrating the relationship between frailty and parameters such as pain, disability, quality of life, physical activity, balance, and fear of falling in individuals with LSS can contribute to the development of more effective rehabilitation strategies for the management of the disease.

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
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with lumbar spinal stenosis by MRI,
  • •Patients between the ages of 45-80,
  • •Patients who can stand independently,
  • •Volunteer to participate in the study

排除标准

  • •Patients who did not agree to participate in the study,
  • •Those with a chronic disease that would affect walking,
  • •Those who had undergone surgery in the lumbar region within the last year,
  • •Those with advanced joint disease in the lower extremity,
  • •Those with malignancy in the spine,
  • •Those with vision and/or vestibular system problems,
  • •Those who did not cooperate well were not included in the study.

研究组 & 干预措施

Patients with frail LSS

Patients with LSS who are frail according to Fried criteria will be assigned to this group. According to the Frid criteria, patients who score 3 or more on the following symptoms have a frailty level: weight loss, weakness, exhaustion, decreased mobility, and physical inactivity.

Patients without frail LSS

Patients with LSS who are not frail according to Fried criteria will be assigned to this group.

结局指标

主要结局

Dynamic balance

时间窗: Baseline

Dynamic balance will be assessed with Timed up and Go test. Time will be recorded in seconds

Disability

时间窗: Baseline

Disability will be assessed using the Oswestry Disability Index. The scale is scored from 0 to 100. A higher score indicates greater disability.

Pain severity

时间窗: Baseline

Pain will be assessed with the numerical pain scale (NRS). NRS varies between 0-10. The higher the score, the greater the pain. Pain will be assessed with the numerical pain scale (NRS). NRS varies between 0-10. The higher the score, the greater the pain. Pain will be assessed with the numerical pain scale (NRS). NRS varies between 0-10. The higher the score, the greater the pain.

Static balance

时间窗: Baseline

Static balance will be assessed with the one-legged standing test. The test is terminated when it is 30 seconds or more, and there is a balance disorder below 10 seconds. Static balance will be assessed with the one-legged standing test. The test is terminated when it is 30 seconds or more, and there is a balance disorder below 10 seconds.

Fear of Falling

时间窗: Baseline

Fear of falling will be assessed with the Fall Efficacy Scale-International. It is scored between 16-64, the higher the score, the greater the fear of falling.

Health related quality of life

时间窗: Baseline

Quality of life will be assessed with Short Form-36. It is scored between 0-100, the higher the score, the higher the quality of life.

次要结局

未报告次要终点

研究者

发起方
Karabuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Musa Güneş

Principal Investigator, PhD

Karabuk University

研究点 (1)

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