Sciatica | Steroids Versus Gabapentin
Sciatica research study
What is the primary objective of this study?
Who is eligible to participate?
Inclusion Criteria: - Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.) - Numerical Rating Scale leg pain score > 4 (or if 3/10, greater or equal to back pain) - MRI evidence of spinal pathology consistent with symptoms Exclusion Criteria: - Untreated coagulopathy - Previous spine surgery - No MRI study - Leg pain > 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation. Pregnancy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:epidural steroid injectionInjection of steroids and local anesthetic into the epidural space
Procedure:Sham epidural steroid injectionInjection of saline into the back muscles
Drug:GabapentinTitration of gabapentin to effect
Drug:Placebo gabapentinTitration of placebo gabapentin
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Epidural steroidsInjection of steroids into the epidural space
GabapentinTitration of gabapentin to effect
Start Date: December 2011
Completed Date: September 2014
Primary Outcome: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale
Secondary Outcome: Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
Study sponsors, principal investigator, and references
Principal Investigator: Steven P Cohen, MD
Lead Sponsor: Johns Hopkins University
Collaborator: Walter Reed National Military Medical Center