NCT03303261

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 4, 2019

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

October 2, 2017

Last Update Submit

February 1, 2019

Conditions

Lumbar Hernia

Outcome Measures

Primary Outcomes (1)

  • pain VAS ( VISUAL ANALOGIC SCORE)

    Day 1 - Day 30

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient hospitalized in GHPSJ for infiltration

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • COHEN SOLAL P Julien, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 6, 2017

Study Start

April 18, 2016

Primary Completion

September 25, 2017

Study Completion

December 31, 2018

Last Updated

February 4, 2019

Record last verified: 2018-03

Locations

FR(1)