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 : Completed
First Posted : September 26, 2012
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Lumbago Modic I Discopathy||Drug: Hydrocortancyl. Drug: Lidocaine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.|
|Actual Study Start Date :||July 12, 2012|
|Actual Primary Completion Date :||March 20, 2017|
|Actual Study Completion Date :||March 20, 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: VAS [ Time Frame: 1 months ]The pain will be assessed by the visual analog scale (VAS).
- Quality of life assessment: SF-36 [ 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.The Dallas Pain Questionnaire (DPQ) assesses the impact of low back pain (LBP) on four components (0-100) of daily life .
- 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. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
- Employment status [ Time Frame: 6 months ]Employment or non-employment status will be noted
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
|Hospital University of Montpellier|
|Montpellier, France, 34000|