Background Among patients presenting with axial low back pain, facet arthropathy accounts for approximately 10-15% of cases. Facet interventions are the second most frequently performed procedures in pain clinics across the United States. Currently, there are no uniformly accepted criteria regarding how best to select patients for radiofrequency denervation. Methods A randomized, multicenter study was performed in 151 subjects with suspected lumbar facetogenic pain comparing three treatment paradigms. Group 0 received radiofrequency denervation based solely on clinical findings; group 1 underwent denervation contingent on a positive response to a single diagnostic block; and group 2 proceeded to denervation only if they obtained a positive response to comparative blocks done with lidocaine and bupivacaine. A positive outcome was predesignated as > or =50% pain relief coupled with a positive global perceived effect persisting for 3 months. Results In group 0, 17 patients (33%) obtained a successful outcome at 3 months versus eight patients (16%) in group 1 and 11 (22%) patients in group 2. Denervation success rates in groups 0, 1, and 2 were 33, 39, and 64%, respectively. Pain scores and functional capacity were significantly lower at 3 months but not at 1 month in group 2 subjects who proceeded to denervation compared with patients in groups 0 and 1. The costs per successful treatment in groups 0, 1, and 2 were $6,286, $17,142, and $15,241, respectively. Conclusions Using current reimbursement scales, these findings suggest that proceeding to radiofrequency denervation without a diagnostic block is the most cost-effective treatment paradigm.

Background Recent evidence implicates the inflammatory cytokine tumor necrosis factor as a major cause of radiculopathy. Yet, whereas open-label studies with systemically delivered tumor necrosis factor inhibitors have yielded positive results, a placebo-controlled study failed to demonstrate efficacy. One variable that may have contributed to poor outcomes is low drug levels at the site of nerve inflammation. To date, no studies have evaluated the efficacy or safety of epidurally administered anti-tumor necrosis factor agents. Methods A double-blind, placebo-controlled, dose-response study was conducted to evaluate an epidural tumor necrosis factor inhibitor. Twenty-four patients with subacute lumbosacral radiculopathy were randomly assigned to receive two transforaminal epidural injections of 2, 4, or 6 mg of entanercept 2 weeks apart in successive groups of eight. In each group, two patients received epidural saline. A parallel epidural canine safety study was conducted using the same injection doses and paradigm as in the clinical study. Results The animal and human safety studies revealed no behavioral, neurologic, or histologic evidence of drug-related toxicity. In the clinical arm, significant improvements in leg and back pain were collectively noted for the etanercept-treated patients, but not for the saline group, one month after treatment. One patient in the saline group (17%), six patients in the 2-mg group (100%), and four patients each in the 4-mg and 6-mg groups (67%) reported at least 50% reduction in leg pain and a positive global perceived effect one month after treatment. Six months after treatment, the beneficial effects persisted in all but one patient. Conclusion Epidural entanercept holds promise as a treatment for lumbosacral radiculopathy.