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临床试验/NCT02827981
NCT02827981撤回不适用

Retrospective Study on the Evaluation of Intra-disc Infiltration in the Active Disc Disease

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change from baseline in Pain Scores on visual Analogue Scale

研究概览

简要总结

Active discopathies or MODIC 1, are a diagnostic entity discovery with the contribution of MRI in which the first cases were described by Dr. Michael MODIC in 1988. It is characterized by a vertebral bone edema secondary to active discarthrose. Its prevalence is estimated at 6% of the general population and up to 40% of the CLBP according to studies. Following the discovery of this recent diagnostic entity, responsible for low back pain, the question of its management is debate in the medical community. Early studies demonstrate the effectiveness of corticosteroid injections in intra-disc. Other works, most recent, suggest the contrary, infectious, incriminating a pathogenic role of certain bacteria such as Propionibacterium acness or Corynebacterium propinquum recommending, in contrast, treatment with prolonged antibiotic therapy. This study will aim to assess the effectiveness of intra-disc infiltration GHPSJ carried out between 2007 and 2014. The innovation of our work will be to assess these infiltrations in various subgroups such as patients with a previous surgery of the spine or a history of scoliosis or spondylolisthesis.

详细描述

  1. Primary objective:

Evaluate the effectiveness of intra-disc infiltrations conducted in the rheumatology department of pain in the active disc disease. 2. Secondary objectives:

  • Evaluate the duration of the benefit on pain caused by gesture
  • Assess the impact of the gesture on NSAIDs and / or analgesics
  • Analysis of different subgroups (antecedent of surgery, spondylolisthesis, scoliosis) Inclusion / non-inclusion: Patients older than 18 who were hospitalized between 2007 and 2014 in the Rheumatology Department for intradiscal infiltration.

Methodology: A retrospective, single-center, non-interventional Study duration: 6 months Acquisition of data: demographic data, data on the disc disease, data on the assessment of pain, the effectiveness of infiltration of analgesics and / or NSAIDs, or need infiltration surgery for the gesture.

Supports: patient questionnaire report hospital, medical, Excel grid of data collection), analysis (statistic: local management) Anonymised data in the Excel spreadsheet Development of the study: Data collection, statistical analysis, literature review Retrospective study based on recovering data regarding efficacy of infiltrative gesture that some patient was performed in 2007, with possibility of bias on the recovery of data in view of the age of the gesture for some patients.

研究设计

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

入排标准

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

入选标准

  • Patient aged > 18yo
  • Hospitalization between 2007 and 2014 in the Rheumatology Department for intradiscal infiltration

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in Pain Scores on visual Analogue Scale

时间窗: Day1, Before and after Intra-disc Infiltration

Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

次要结局

  • Amount of analgesic taken(Day1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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