Steroids Versus Gabapentin

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