跳至主要内容
临床试验/NCT03918512
NCT03918512撤回不适用

Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 200 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
撤回
入组人数
200
试验地点
1
主要终点
Lumbar Spinal Stenosis-specific activity limitation in patients with Lumbar Spinal Stenosis

研究概览

简要总结

To develop and validate a questionnaire aiming at assessing specific activity limitation in patients with lumbar spinal stenosis (LSS).

详细描述

Construction of the provisional questionnaire :

In a first step, semi-structured in-depth individual interviews were conducted from September 20, 2016 to January 4, 2017, in 20 patients fulfilling inclusion criteria to collect concepts related to LSS-specific activity limitation, participation restriction and patients' views about their condition. Thematic content was analysed using investigator triangulation. Overall, 57 items were generated by patients. 48 items were related to LSS-specific activity limitation and were used to construct the provisional 48-item Cochin L3S questionnaire (CL3S-48). Acceptability and understandability of the provisional CL3S-48 questionnaire was tested and consolidated in 10 patients with LSS.

Item reduction and validation of the questionnaire :

In a second step, 200 eligible patients according to our medical records will be informed by email of the purpose of the study, their non-opposition to the collection of data will be collected and patients will be invited to complete the following online self-administered questionnaires at baseline, 7 days and 3 months:

  • Demographical and clinical characteristics at baseline
  • Consolidated version of the CL3S-48 questionnaire
  • Lumbar pain numeric rating scale (NRS)
  • Radicular pain NRS
  • Zurich Claudication Questionnaire (ZCQ) physical function subscale
  • Oswestry Disability Index (ODI)
  • Fukushima LSS Scale 25 (FLS-25)
  • 12-Item Short Form Health Survey (SF-12)
  • 1 anchoring question about patient acceptable symptom state
  • 1 anchoring question about patient minimal clinically important difference at 3 months.

研究设计

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

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 ≥ 50 year old
  • with lumbar spinal stenosis (LSS) according to medical records.

排除标准

  • lumbar spinal surgery,
  • cognitive impairment and inability to speak and/or understand French.

结局指标

主要结局

Lumbar Spinal Stenosis-specific activity limitation in patients with Lumbar Spinal Stenosis

时间窗: at baseline

To develop and validate a questionnaire aiming at assessing specific activity limitation in patients with LSS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验