Low Back Pain, Lumbago, Modic I Discopathy
Conditions
Keywords
Discopathy, Modic I, Corticoids, Local Anaesthetic, Intradiscal injection
Brief summary
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
This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.
Interventions
DRUGHydrocortancyl.
Patients will receive an intradiscal injection of hydrocortancyl.
DRUGLidocaine
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment: VAS | 1 month | The pain will be assessed by the visual analog scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment: VAS | 1 week, 2 weeks, 3 weeks, 3 months, 6 months | The pain will be assessed by the visual analog scale (VAS). |
| Quality of life assessment: SF-36 | 1 month, 3 months, 6 months | Quality of life will be assessed by the self-questionnaire SF-36. |
| Consumption of analgesics and NSAIDs assessment | 1 month, 3 months,6 months | — |
| Specific low back pain parameters assessment | 1 month, 3 months,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 . |
| Employment status | 1 month, 3 months,6 months | Employment or non-employment status will be noted |
Countries
France
Outcome results
None listed