Skip to content

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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02827981
Acronym
MODIC
Enrollment
0
Registered
2016-07-11
Start date
2015-05-31
Completion date
2015-05-31
Last updated
2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disc Disease

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.

Interventions

None listed

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in Pain Scores on visual Analogue ScaleDay1, Before and after Intra-disc InfiltrationChange From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

Secondary

MeasureTime frame
Amount of analgesic takenDay1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026