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

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.

Study Overview

• Status: Withdrawn
• Conditions: Disc Disease

Detailed Description

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.

An analysis of each folder from the hospital report will be carried out in parallel in order to compare the data collected by the questionnaire with the reporting. The sending of questionnaires and letters will be performed by the service attaches where a pre-stamped letter. The address of the patients will be that recorded in the base DxCare.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Amount of analgesic taken	Day1

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: ISRAEL Jonathan, MD, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: MODIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED