Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

Official Title
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Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.

Conditions
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Low Back Pain, Lumbago, Modic I Discopathy

Intervention / Treatment
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* Drug: Hydrocortancyl.
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 years Signed Informed consent Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI) Exclusion Criteria: Past history of lumbar surgery Patient under anticoagulant or antisludge treatment, or with coagulation troubles Patient with unbalanced diabetes mellitus (blood glucose > 1.30 g/l) Patient with unstabilized high blood pressure (> 160/95 mmHg) Patient with evolving infection Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components Porphyria, hypersensitivity to local anaesthetic Patient with sphincter troubles showing a cauda equine syndrome Untreated psychotic state Pregnant women or of childbearing age without effective contraception means Impossible 6 months follow-up Participation to another trial Vulnerable persons protected by the law Persons under guardianship Persons unable to express their consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticoids<br>A group of patients will receive an intradiscal injection of Hydrocortancyl. | Drug: Hydrocortancyl.<br>* Patients will receive an intradiscal injection of hydrocortancyl.<br>|
| Sham Comparator: Local anaesthetic<br>A group of patients will receive an intradiscal injection of Lidocaine. | Drug: Lidocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment: VAS | The pain will be assessed by the visual analog scale (VAS). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment: VAS | The pain will be assessed by the visual analog scale (VAS). | 1 week, 2 weeks, 3 weeks, 3 months, 6 months | 
| Quality of life assessment: SF-36 | Quality of life will be assessed by the self-questionnaire SF-36. | 1 month, 3 months, 6 months | 
| Consumption of analgesics and NSAIDs assessment |  | 1 month, 3 months,6 months | 
| Specific low back pain parameters assessment | 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 . | 1 month, 3 months,6 months | 
| Specific low back pain parameters assessment | Low back pain parameters will be assessed by 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. | 1 month, 3 months,6 months | 
| Employment status | Employment or non-employment status will be noted | 1 month, 3 months,6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Discopathy, Modic I, Corticoids, Local Anaesthetic, Intradiscal injection