Ignite Creation Date:
2024-05-06 @ 8:48 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02827981
Status:
WITHDRAWN
Last Update Posted:
2017-02-17
First Post:
2016-06-29
Brief Title:
Retrospective Study on the Evaluation of Intra-disc Infiltration in the Active Disc Disease
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Retrospective Study on the Evaluation of Intra-disc Infiltration in the Active Disc Disease
Status:
WITHDRAWN
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MODIC
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None