Steroids Versus Gabapentin
Steroids Versus Gabapentin
The purpose of this study is to determine whether pharmacotherapy or epidural steroid
 injections are a better treatment for lumbosacral radicular pain.

 142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be
 randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will
 be allocated to receive an epidural steroid injection (ESI; group I), with an equal number
 allocated to receive gabapentin (group II). Patients & evaluating physicians will be blinded.
 Follow-up will be through 3-months after treatment.
142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be
 randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will
 be allocated to receive an ESI (group I), with an equal number allocated to receive
 gabapentin (group II).

 Group I patients with unilateral symptoms will receive (unilateral) transforaminal ESI, while
 those with bilateral symptoms will receive (central) interlaminar ESI, as is common practice.

 In group II patients who receive gabapentin, the dose will be titrated to between 1800 mg/d
 and 2700 mg/d in TID dosing, but may be lowered or elevated (up to 3600 mg/d) depending on
 the clinical circumstances. To ensure blinding, these patients will also receive midline (for
 patients with bilateral symptoms who would receive interlaminar ESI) or unilateral paraspinal
 (for patients with unilateral symptoms who would receive transforaminal ESI) normal saline
 into the interspinal ligaments or paraspinal musculature, respectively. Injections and
 medication titration will commence on the same day.

 Rescue medications will consist of tramadol 50 mg 1 to 2 tablets every 6 hours PRN (up to
 8/d) and/or ibuprofen 400-800 mg every 6 hours PRN (not-to-exceed 3000 mg/d). Patients
 already taking analgesics, including opioids, can continue on these medications "as needed".

 The first follow-up visit will be scheduled 1-month from the start of treatment. A positive
 outcome will be defined as a > 2-point decrease in leg pain coupled with a positive
 satisfaction rating. Subjects who obtain a positive outcome at their initial 1-month
 follow-up visit will remain in the study and return for the final 3-month follow-up visit.
 Those with a negative outcome will exit the study "per protocol" to receive standard care,
 which may consist of unblinded ESI, medical management with drugs such as gabapentin (for
 those who did not receive gabapentin) and antidepressants, and physical therapy. Subjects who
 obtain a positive outcome at 1-month but experience a recurrence before their 3-month
 follow-up visit will also exit the study per protocol, with their final outcome measures
 recorded before they receive standard care. At all follow-up visits, pill counts will be
 conducted to determine medication compliance.
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