Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. (MODISC)
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|ClinicalTrials.gov Identifier: NCT01694134|
Recruitment Status : Recruiting
First Posted : September 26, 2012
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Lumbago Modic I Discopathy||Drug: Hydrocortancyl. Drug: Lidocaine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
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.
- Pain assessment [ Time Frame: 6 months ]The pain will be assessed by the visual analog scale (VAS).
- Quality of life assessment [ Time Frame: 6 months ]Quality of life will be assessed by the self-questionnaire SF-36.
- Consumption of analgesics and NSAIDs assessment [ Time Frame: 6 months ]
- Specific low back pain parameters assessment [ Time Frame: 6 months ]Low back pain parameters will be assessed by the Dallas scale and the Oswestry scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694134
|Contact: Isabelle Tavares, MD||+334 67 33 88 firstname.lastname@example.org|
|Hospital University of Montpellier||Recruiting|
|Montpellier, France, 34000|
|Contact: Isabelle Tavares, MD +334 67 33 88 26 email@example.com|
|Principal Investigator: Isabelle Tavares, MD|