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临床试验/NCT05022017
NCT05022017已完成不适用

EOS MODIC : Inflammatory Disc Disease: Description of Statics by EOS Imaging and Evaluation of the Efficacy of Intradiscal Corticosteroid Infiltration

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Evaluate the effectiveness of the intra-disc infiltration at 3 months on the pain felt by the patient.

研究概览

简要总结

Inflammatory disc disease or Modic 1 disc disease is a radiological entity first described by Modic in 1988 and corresponds to an inflammatory signal on MRI defined by the presence of a T2-weighted hypersignal and a T1-weighted hyposignal of the vertebral endplates adjacent to a pathological disc.

The presence of these radiological abnormalities are significantly associated with chronic low back pain, the therapeutic management of which may include lumbar rehabilitation, rigid corset, spinal infiltrations and surgical treatment. Corticosteroid infiltration of the pathological intervertebral disc (intradiscal infiltration) has been evaluated in low back pain due to Modic 1 disc disease with short-term efficacy. The clinical response to this infiltration is not always optimal and to date in the literature, no predictive factor of response has been identified.

详细描述

There are several hypotheses to explain this phenomenon: mechanical, genetic, infectious or inflammatory. One of the mechanical hypotheses would be the presence of an instability of the spinal segment (hypermobility of the spinal segment) and disorders of the sagittal statics of the spine with angles of thoracic kyphosis and lumbar lordosis weak and a weak sacral slope supporting a hyperpressure passing by the discs and the genesis of discopathy.

In this work, the investigators will evaluate the different parameters of the spinal statics in the sagittal plane and in the frontal plane (sacral slope, pelvic version, Roussouly classification, cobb angle...) by EOS imaging as well as the parameters of the Modic 1 anomaly on lumbar MRI (spinal stage, Pfirmann classification, laterality of the inflammatory signal) in a population of patients who received intradiscal corticosteroid infiltration for low back pain in the context of Modic 1 disc disease.

The analysis of the different radiological parameters could enrich the investigator's understanding of the pathophysiology and evaluate radiological factors predictive of the effectiveness of intradiscal infiltration in this population. This could allow us to adapt the management of low back pain patients with Modic 1 disc disease.

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 whose age ≥ 18 years
  • French speaking patient
  • Patient hospitalized in the rheumatology department of GHPSJ between 01/01/2014 and 31/12/2020 for MODIC 1
  • Patients who received as part of their management an intra-disc infiltration with hydrocortancyl.

排除标准

  • Patient under guardianship or curators
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his data for this research
  • Patient having benefited from another infiltration between the intradiscal infiltration and the collection of efficacy data at 3 months.

结局指标

主要结局

Evaluate the effectiveness of the intra-disc infiltration at 3 months on the pain felt by the patient.

时间窗: 3 months

Percentage of patients with improved low back pain defined as a decrease in Visual Analogue Scale (VAS) pain \>3 at 3 months after intradiscal infiltration compared to VAS at admission. VAS scale : minimum score 0 (no pain) / higher score 10 (greater pain intensity)

次要结局

  • Describe the parameters of spinal statics in the frontal planes in Modic 1 disc disease.(3 months)
  • Change in analgesic consumption (Level 1, Level 2, Level 3 and NSAIDs) at 3 months.(3 months)
  • Compare the parameters of spinal statics according to the different stages of Modic 1 disc disease(3 months)
  • Predictive factors (clinical and radiological) of the effectiveness of intra-disc infiltration(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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