Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385086
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2006-10-04
Brief Title:
Lumbar Spinal Fibrosis and TNF Alpha Inhibition
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 mgkg 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
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 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None