Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. (MODISC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01694134|
Recruitment Status : Unknown
Verified May 2016 by University Hospital, Montpellier.
Recruitment status was: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|