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临床试验/NCT07058350
NCT07058350已完成不适用

Association Between Radiological Stenosis Level and Patient Questionnaires in Patients With Lumbar Spinal Stenosis: A Cross-Sectional Study

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年6月1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
120
试验地点
1
主要终点
Oswestry Disability Index

研究概览

简要总结

One of the important causes of low back pain is lumbar spinal stenosis. With the increasing prevalence of magnetic resonance imaging (MRI), lumbar spinal stenosis grading systems have been developed. The Lee and Schizas lumbar spinal stenosis grading systems are widely used. Patient questionnaires are also used especially in treatment follow-ups. This study aimed to compare the compliance of patient questionnaires with the presence or absence of radiological stenosis and the degree of stenosis if present.

详细描述

Patients who apply to our Physical Medicine and Rehabilitation out-patient clinic with complaints of low back pain and who have or do not have lumbar spinal stenosis on lumbar spinal MRI will be screened. Demographic values, accompanying diseases, radiological staging of lumbar spinal stenosis, Oswestry Disability Index, Istanbul Low Back Pain Disability Questionnaire, Swiss Spinal Stenosis Questionnaire will be evaluated. Pain levels will be evaluated with Visual Analog Scale (VAS). Radiological stenosis level will be determined with Lee radiological spinal stenosis classification system. Those with and without stenosis will be determined. In addition, subgroup analysis will be performed by creating subgroups with mild, moderate and severe stenosis in the stenosis group. Evaluations will be made at the L4-L5 vertebrae level, where degenerative spinal stenosis is most frequently seen. All questionnaires will be filled in both groups with and without stenosis.

研究设计

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

入排标准

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

入选标准

  • Patients aged 50 and over with low back pain
  • Those who have had a lumbar magnetic resonance imaging (MRI) scan within the last year

排除标准

  • Patients with congenital lumbar spinal stenosis
  • Patients with traumatic lumbar spinal stenosis
  • Patients with iatrogenic lumbar spinal stenosis
  • Those with a history of lumbar vertebral surgery
  • Those with cognitive impairment

结局指标

主要结局

Oswestry Disability Index

时间窗: Day 1

The Oswestry Disability Index (ODI) is used to measure the degree of functional limitations caused by pain in patients with low back pain. The questionnaire provides the user with detailed information about the general daily functioning of a patient with low back pain. Questions are included regarding pain intensity, self-care, lifting, moving, sitting or standing, sleeping, sexual life, social life, and travel/transportation. A score of 0 indicates no limitations due to pain, while a score of 5 indicates the greatest perceived limitation in an activity due to pain. It is calculated by dividing the total score by the score range and multiplying the result by 100 to obtain the percentage value of the index. 0% indicating no disability and 100% indicating the highest level of disability.

İstanbul Low Back Pain Disability Questionnaire

时间窗: Day 1

The Istanbul Low Back Pain Disability Index consists of 18 questions that evaluate the effects of low back pain on activities such as going up and down stairs, walking, bathing, brushing teeth, dressing, etc. If a person can do it "without any difficulty", 0 points, if "with little difficulty", 1 point, if "with some difficulty", 2 points, if "with great difficulty", 3 points, if "almost impossible", 4 points, and "impossible" (5 points) are used to obtain a total score of 0-90. A total score of 0 indicates no disability, while 90 indicates maximum disability.

Swiss Spinal Stenosis Questionnaire

时间窗: Day 1

The Swiss Spinal Stenosis Questionnaire consists of 18 questions. The first 7 questions concern the patient's symptoms. The first three questions concern pain (intensity, frequency and back pain) and the last four questions concern neuroischemic symptoms (numbness or tingling, weakness and balance disorders). Each question is scored from 1 to 5 (maximum 35 points). The next 5 questions concern the patients' physical activity and each question is scored from 1 to 4 (maximum 20 points). A higher score indicates a more severe disease. The last 6 questions concern the patients' satisfaction with surgical treatment and each is scored from 1 to 4. A higher score indicates less satisfaction with surgery.

次要结局

  • Visual Analog Scale(Day 1)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selda Çiftci

Medical Doctor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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