Clinical trial NCT01495923
Conditions: Sciatica Radiculopathy
Keywords: low back pain radiculopathy injection
Sponsor: Johns Hopkins University
Start date: 2011-12-01; Completion date: 2014-09-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Injection of steroids into the epidural space arm 2: Titration of gabapentin to effect
Interventions: intervention 1: epidural steroid injection intervention 2: Sham epidural steroid injection intervention 3: Gabapentin intervention 4: Placebo gabapentin
Intervention descriptions: intervention 1: Injection of steroids and local anesthetic into the epidural space intervention 2: Injection of saline into the back muscles intervention 3: Titration of gabapentin to effect intervention 4: Titration of placebo gabapentin

Protocol documents: