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

NCT02827981 | Withdrawn DMC

• 1 other identifier: MODIC
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disc Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Pain Scores on visual Analogue Scale

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

  Day1, Before and after Intra-disc Infiltration

Secondary Outcomes (1)

• Amount of analgesic taken

  Day1

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

Patients hospitalized between 2007 and 2014 in the Rheumatology Department for intradiscal infiltration.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Study Officials

• ISRAEL Jonathan, 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: June 29, 2016
• First Posted: July 11, 2016
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 17, 2017

Record last verified: 2016-06

Locations

FR (1)