Completed
MODISCAssessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
What is being tested
Hydrocortancyl.
+ Lidocaine
Drug
Who is being recruted
Back Pain+3
+ Neurologic Manifestations
+ Pain
From 18 to 80 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: July 2012
Summary
Principal SponsorUniversity Hospital, Montpellier
Last updated: February 5, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: July 12, 2012
Actual date on which the first participant was enrolled.This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.
Principal SponsorUniversity Hospital, Montpellier
Last updated: February 5, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Back PainNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsLow Back Pain
Criteria
3 inclusion criteria required to participate
Age between 18 and 80 years
Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)
Signed Informed consent
15 exclusion criteria prevent from participating
Impossible 6 months follow-up
Participation to another trial
Past history of lumbar surgery
Patient under anticoagulant or antisludge treatment, or with coagulation troubles
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorA group of patients will receive an intradiscal injection of Hydrocortancyl.
Group II
ShamA group of patients will receive an intradiscal injection of Lidocaine.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Hospital University of Montpellier
Montpellier, FranceOpen Hospital University of Montpellier in Google MapsCompletedOne Study Center