A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
Condition: Lumbosacral Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and
      worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2
      concluded them to be effective in the long-term. In our own double-blind, placebo-controlled
      study evaluating epidural etanercept, the results showed significant benefit in favor of the
      etanercept group, but no subject was included with a duration of pain > 9 months, and the
      results of this study have yet to be replicated.

      Currently, epidural steroid injections are the most frequently performed procedures in pain
      clinics across the U.S. However, epidural steroids may benefit only a select group of
      patients. The literature on treating sciatica is notable for a lack of randomized comparative
      studies involving various treatments. The objective of this project is to conduct a 3-arm
      study to determine the efficacy of 1) transforaminal epidural corticosteroids; and 2)
      transforaminal epidural etanercept, in patients with lumbosacral radiculopathy.
    

Detailed description: 
      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.
    

Intervention name(s): etanercept; methylprednisolone; normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two transforaminal epidural injections of 4 mg, two weeks apart; Two transforaminal epidural steroid injections with 60 mg, two weeks apart; Two transforaminal epidural saline injections, two weeks apart
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Etanercept; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: radiculopathy; sciatica; low back pain