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

Disc Disease Clinical Trial

— MODIC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02827981
• Other study ID #: MODIC
• Status: Withdrawn
• Phase: N/A
• First received: June 29, 2016
• Last updated: February 16, 2017
• Start date: May 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged > 18yo

• Hospitalization between 2007 and 2014 in the Rheumatology Department for intradiscal infiltration

Exclusion Criteria:

Related Conditions & MeSH terms

• Disc Disease
• Spinal Diseases

Locations

Country	Name	City	State
France	Groupe hospitalier Paris Saint-Joseph	Paris

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	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	Amount of analgesic taken		Day1