Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. (MODISC)
The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.
Low Back Pain
Modic I Discopathy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.|
- Pain assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]The pain will be assessed by the visual analog scale (VAS).
- Quality of life assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Quality of life will be assessed by the self-questionnaire SF-36.
- Consumption of analgesics and NSAIDs assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Specific low back pain parameters assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Low back pain parameters will be assessed by the Dallas scale and the Oswestry scale.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Corticoids
A group of patients will receive an intradiscal injection of Hydrocortancyl.
Patients will receive an intradiscal injection of hydrocortancyl.
Sham Comparator: Local anaesthetic
A group of patients will receive an intradiscal injection of Lidocaine.
This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694134
|Contact: Isabelle Tavares, MD||+334 67 33 88 email@example.com|
|Hospital University of Montpellier||Recruiting|
|Montpellier, France, 34000|
|Contact: Isabelle Tavares, MD +334 67 33 88 26 firstname.lastname@example.org|
|Principal Investigator: Isabelle Tavares, MD|