Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.
Overview
- Phase
- Phase 3
- Intervention
- Hydrocortancyl.
- Conditions
- Low Back Pain
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pain assessment: VAS
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Corticoids
A group of patients will receive an intradiscal injection of Hydrocortancyl.
Intervention: Hydrocortancyl.
Local anaesthetic
A group of patients will receive an intradiscal injection of Lidocaine.
Intervention: Lidocaine
Outcomes
Primary Outcomes
Pain assessment: VAS
Time Frame: 1 month
The pain will be assessed by the visual analog scale (VAS).
Secondary Outcomes
- Pain assessment: VAS(1 week, 2 weeks, 3 weeks, 3 months, 6 months)
- Specific low back pain parameters assessment(1 month, 3 months,6 months)
- Employment status(1 month, 3 months,6 months)
- Quality of life assessment: SF-36(1 month, 3 months, 6 months)
- Consumption of analgesics and NSAIDs assessment(1 month, 3 months,6 months)