Post Operative Sciatica by Lumbar Spinal Fibrosis Clinical Trial
Official title:
Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.
OBJECT:
Failed back surgery syndrome is still a challenging therapeutic problem. Clinical studies
have demonstrated a significant association between lumbar spinal fibrosis after lumbar
discectomy and the recurrence of radicular pain in 25% of cases. Forceful epidural
infiltrations, radiotherapy, therapy with D-penicillamine or surgical procedures have had
unfavourable results in terms of pain and cost. Magnetic resonance imaging reveals lumbar
spinal fibrosis by a hyposignal in the T1 sequence and a hypersignal in T2 sequence around
the spinal tissue. Tumor necrosis factor a (TNF-a) is the main cytokine implicated in the
formation of tissue fibrosis. In animal models of fibrosis, TNF-a inhibition has been shown
to prevent and treat tissue fibrosis.
HYPOTHESIS:
Inhibiting TNF-a could significantly decrease sciatica pain because of lumbar spinal
fibrosis after lumbar discectomy by decreasing spinal fibrosis.
METHODS:
We propose a 2-year pilot prospective, randomized, double-blind, controlled study of TNF-a
inhibitor (infliximab) in patients with sciatica as a result of postoperative lumbar spinal
fibrosis. The infliximab group will receive one intravenous injection of 3 mg/kg infliximab.
The control group will receive one physiological serum injection. Patients will be evaluated
at day 0, 10, 30, 90, and 180. The main evaluation criterion will be sciatica pain as
measured on a visual analog scale, with the objective of a 50% decrease in pain at day 10.
This objective leads to a size of 20 patients per group. The other evaluation criteria will
be clinical, functional, social, and professional. Patients will be recruited from the
rehabilitation unit at Cochin teaching hospital.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment