A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy

This is a 3-arm multi-center, randomized, double-blind, placebo-controlled study comparing
two treatments with transforaminal epidural saline. Each group will receive a 2nd procedure
identical to the first 2 weeks after the initial procedure.

Seventy-eight study participants will be randomized via a computerized randomization system
using SPSS software in groups of 6 at each institution by a research nurse not involved in
patient care. There will be 26 patients in each of the 3 groups. A physician unaware of
the patient's treatment group will place 22-gauge needles in the relevant foramen under
fluoroscopic guidance as determined by patient's symptoms and MRI findings. Once correct
placement is confirmed by contrast injection, the blinded physician will leave the room and
another physician will inject the medication. In group I, this will be 60 mg of
depo-methylprednisolone. In group II, this will be 4 mg of etanercept reconstituted in 2 ml
of sterile water. In group III, this will be normal saline.

Two weeks after the initial procedure, an identical procedure to the first one will be done
by the same physician or his designate. In addition to the study medication, each patient
in each group will receive 0.5 ml of 0.5% bupivacaine local anesthetic for immediate pain
relief during both injections before the study drug is delivered. The efficacy of blinding
will be assessed by a disinterested observer unaware of the randomization results after the
second procedure before discharge. Follow-up visits will be conducted one, three and six
months after the second injection, for those subjects who continue to experience > 50% pain
relief.