Study On Discopathie With Modic 1

February 1, 2019 updated by: Groupe Hospitalier Paris Saint Joseph
The chronic lumbago can be associated with an active discopathie, objectified on the MRI by the presence of an inflammatory signal (Modic 1) or greasy (Modic 2) vertebral trays framing the pathological vertebral disk The treatment recommended by t consists in particular of a local infiltration of corticoids which the efficiency is variable according to the patients. The objective of this study is to estimate the efficiency of the local treatment and to highlight some of the factors associated to the advantage of the infiltration by corticoids.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient hospitalized in GHPSJ for infiltration

Description

Inclusion Criteria:

  • Patient admitted in Rhumatology service for intra-disc infiltration
  • Chronic pain (>3 monts)
  • VAS >3
  • MRI stipulating MODIC 1

Exclusion Criteria:

  • radiculalgy
  • radicular VAS< lumbar VAS
  • pregnancy
  • local infection
  • corticoid allergy
  • previous rachial surgery
  • previous spondylodiscite
  • psychiatric disorder
  • MRI contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain VAS ( VISUAL ANALOGIC SCORE)
Time Frame: Day 1 - Day 30
Day 1 - Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: COHEN SOLAL P Julien, MD, Groupe Hospitalier Paris Saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2016

Primary Completion (Actual)

September 25, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MODIC 1 PRO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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