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TerminatedNCT03303261Updated Feb 4, 2019

Study On Discopathie With Modic 1

An observational study in Lumbar Hernia, sponsored by Fondation Hôpital Saint-Joseph. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Why this study was terminated
The principal investigator decided to stop the study.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lumbar Hernia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

patient hospitalized in GHPSJ for infiltration

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • radiculalgy
  • radicular VAS\< lumbar VAS
  • pregnancy
  • local infection
  • corticoid allergy
  • previous rachial surgery
  • previous spondylodiscite
  • psychiatric disorder
  • MRI contraindication
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. pain VAS ( VISUAL ANALOGIC SCORE)

    Time frame: Day 1 - Day 30

06

Study locations

1 site
  • Groupe Hospitalier Paris Saint Joseph
    Paris, Ile-de-France 75014, France
07

Registry details

Key details

Study ID
NCT03303261
Lead sponsor
Fondation Hôpital Saint-Joseph
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Apr 18, 2016
Primary completion
Sep 25, 2017
Completion
Dec 31, 2018
Last update
Feb 4, 2019

Study contacts

COHEN SOLAL P Julien, MD
principal investigator · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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