Description of Statics by EOS Imaging and Evaluation of the Efficacy of Intradiscal Corticosteroid Infiltration

Inflammatory Disease Clinical Trial

— EOSMODIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022017
• Other study ID #: EOS MODIC
• Status: Completed
• Start date: May 3, 2021
• Est. completion date: April 26, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 26, 2023
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Inflammatory Disease

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of the intra-disc infiltration at 3 months on the pain felt by the patient.	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)	3 months
Secondary	Change in analgesic consumption (Level 1, Level 2, Level 3 and NSAIDs) at 3 months.	Consumption of level 1, 2 or 3 painkillers and NSAIDs in the previous week (number of doses per day and per week).	3 months
Secondary	Describe the parameters of spinal statics in the frontal planes in Modic 1 disc disease.	Distribution of the values of the parameters of the spinal statics in the sagittal plane (sacral slope, pelvic incidence, pelvic version, lumbar lordosis, Roussouly classification) and in the frontal plane (cobb angle).	3 months
Secondary	Compare the parameters of spinal statics according to the different stages of Modic 1 disc disease	Distribution of the values of spinal statics parameters in the sagittal plane (sacral slope, pelvic incidence, pelvic version, lumbar lordosis, Roussouly classification) and in the frontal plane (cobb angle) according to the presence of low lumbar (L4L5 L5S1) or high lumbar (L1L2 L2L3 L3L4) disc disease.	3 months
Secondary	Predictive factors (clinical and radiological) of the effectiveness of intra-disc infiltration	Correlation between pain improvement 3 months after infiltration and the type of disc disease (cobb scoliosis > 10°) as well as the parameters of spinal statics in the sagittal and frontal planes and the type of disc damage according to the Pfirmann classification	3 months