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

NCT05022017 | Completed

• 1 other identifier: EOS MODIC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in analgesic consumption (Level 1, Level 2, Level 3 and NSAIDs) at 3 months.

  3 months

• Describe the parameters of spinal statics in the frontal planes in Modic 1 disc disease.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient hospitalized in the rheumatology department of GHPSJ between 01/01/2014 and 31/12/2020 for MODIC 1

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Thomas HUET, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: August 26, 2021
• Study Start: May 3, 2021
• Primary Completion: June 3, 2021
• Study Completion: April 26, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)