Steroids Versus Gabapentin
Condition: Sciatica; Radiculopathy
MeSH terms: Radiculopathy; Sciatica
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): epidural steroid injection; Sham epidural steroid injection; Gabapentin; Placebo gabapentin
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Injection of steroids and local anesthetic into the epidural space; Injection of saline into the back muscles; Titration of gabapentin to effect; Titration of placebo gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; radiculopathy; injection