Clinical Trial: Adalimumab in Severe and Acute Sciatica

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Adalimumab in Severe and Acute Sciatica

Brief Summary: The purpose of this study is to determine whether adalimumab (a TNF-alpha inhibitor) is effective in the treatment of severe and acute sciatica.

Detailed Summary: Sciatica and low back pain are common problems that lead to major costs in Western countries. The presence of herniated disc is generally considered as the leading cause of sciatica. However, recent findings indicate that the presence of this mechanism is not sufficient to explain all the clinical signs of radiculopathy and that inflammatory mechanisms contribute also to the pathophysiology of sciatica. Indeed, herniated discs contain large amounts of tumor necrosis factor (TNF-alpha) which can induce acute and chronic inflammation and pain. It has recently been demonstrated that TNF-alpha inhibitors (infliximab or etanercept) were able to prevent the occurrence of pain in an experimental model of sciatica. In addition, two independent preliminary studies have shown that patients treated with TNF-alpha inhibitors had better evolution than an historical control group. This study has been designed to verify the hypothesis that TNF-alpha has a major role in human sciatica and that anti-TNF-alpha agents are interesting therapeutic approaches in severe sciatica.
Sponsor: University Hospital, Geneva

Current Primary Outcome: Evolution of leg pain over time. Pain will be assessed using a Visual Analog Scale (VAS). [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of amelioration for VAS and ODI (Oswestry Disability Index) [ Time Frame: 6 months ]
  • Assessment of patient's statisfaction and expectations using the SF12 general health questionnaire. [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: May 4, 2007
Date Started: May 2005
Date Completion:
Last Updated: June 6, 2008
Last Verified: June 2008