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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03303261
Other study ID # MODIC 1 PRO
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 18, 2016
Est. completion date December 31, 2018

Study information

Verified date March 2018
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date December 31, 2018
Est. primary completion date September 25, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain VAS ( VISUAL ANALOGIC SCORE) Day 1 - Day 30