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临床试验/NCT04379765
NCT04379765已完成不适用

Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3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
40
试验地点
1
主要终点
Clinical Evaluation 3 Istanbul waist pain disability index

研究概览

简要总结

Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.

详细描述

Patients between 40-85 years old who are hospitalized and treated with the diagnosis of LSS in Physical Medicine and rehabilitation, Orthopedics and Neurosurgery Clinics will be included in the study. The diagnosis of LSS will be made by MR and / or CT and neurogenic claudication history.

Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment, and the duration of the study is considered to be 24 months. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.

Clinical evaluation will be done by the same physician. In patients with spinal stenosis, pain (movement, rest, night) VAS, functional status walking distance and ILBDI (Istanbul waist pain disability index) inquiry form, Nottingham Extended Life Profile will be used.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be between 40-85 years old
  • Defining neurogenic claudication in patient anamnesis
  • Diagnosis of lumbar stenosis in MR and / or CT imaging
  • The duration of the symptom should be at least 4 weeks
  • Other causes of low back pain have been ruled out

排除标准

  • Having had lumbar surgery before
  • Physical therapy for lumbar spinal stenosis less than 3 months ago
  • Any lumbar injection has been applied before
  • Patients with inflammatory low back pain
  • Patients with spinal stenosis due to spondylolysis and / or spondylolisthesis
  • Patients with a history of trauma and suspected Vertebral fracture

结局指标

主要结局

Clinical Evaluation 3 Istanbul waist pain disability index

时间窗: 1st month

In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.

Clinical Evaluation 4 Nottingham Extended Life Profile

时间窗: 1st month

In patients with spinal stenosis, Nottingham Extended Life Profile will be used.

Clinical Evaluation VAS (visual analog scale) for pain assessment

时间窗: 1st month

Clinical evaluation will be done by the same physician. In patients with spinal stenosis, VAS (visual analog scale) for pain assessment will be used.

Clinical Evaluation 2 functional status walking distance

时间窗: 1st month

In patients with spinal stenosis, functional status walking distance will be used.

次要结局

  • Clinical Evaluation 5(12th month)
  • Clinical Evaluation 6(12th month)
  • Clinical Evaluation 8(12th month)
  • Clinical Evaluation 7(12th month)

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

Aylin Ayyıldız

Medical Doctor in Physical Medicine and Rehabilitation

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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