Lateral parasagittal versus midline interlaminar lumbar epidural steroid injection for management of low back pain with lumbosacral radicular pain: a double-blind, randomized study.

BACKGROUND: Epidural steroid injections are commonly used for management of low back pain with lumbosacral radicular pain and can be administered by either interlaminar or transforaminal routes. The transforaminal route is reported to be more effective than the interlaminar route due to higher delivery of drug at the ventral epidural space. However, the transforaminal route has been associated with serious complications including spinal cord injury and permanent paralysis. Hence, there is a search for a technically better route with fewer complications for drug delivery into the ventral epidural space. Recently, a parasagittal interlaminar (PIL) approach of epidural contrast injection was reported to have 100% ventral epidural spread. However, the therapeutic efficacy of this route has never been investigated. We compared the therapeutic efficacy of the PIL approach and midline interlaminar (MIL) approach. We hypothesized that the PIL approach may produce a better clinical outcome because of better ventral epidural spread of the drug compared with MIL approach.
METHODS: Thirty-seven patients were randomized to receive injection of 80 mg methylprednisolone either by the PIL (PIL group, n = 19) or MIL (MIL group, n = 18) approach under fluoroscopic guidance. Patients were evaluated for effective pain relief (≥50% from baseline) by visual analog scale and improvement in disability by the modified Oswestry Disability Questionnaire at intervals of 15 days, 1, 2, 3, and 6 months. Patients having <50% pain relief from baseline received additional epidural injection of the same drug, dosage, and route, a maximum of 3 injections at least 15 days apart. The primary outcome of our study was the incidence of effective pain relief at 6 months.
RESULTS: The incidence of patients having effective pain relief was higher with the PIL approach (13/19 [68.4%]) vs MIL (3/18 [16.7%]) at the end of 6 months. A significantly higher relative success of effective pain relief was noted in the PIL group (relative risk, 4.10; 95% confidence interval, 1.40-12.05; P = 0.001) at the end of the 6-month follow up with the requirement of fewer total injections (29 vs 41 in MIL, P = 0.043). Visual analog scale and modified Oswestry Disability Questionnaire scores were significantly lower in the PIL group compared with the MIL group at all time intervals after the procedure. Ventral epidural spread of contrast was significantly higher in the PIL 89.7% vs 31.7% in the MIL group. The administration of epidural steroid injection was without any complications with an exact 95% Clopper-Pearson confidence interval of 0.0% to 17.6% in the PIL group and 0.0% to 18.5% in the MIL group.
CONCLUSIONS: Epidural steroid injection administered with the PIL approach was significantly more effective for pain relief and improvement in disability than the MIL approach for 6 months in the management of low back pain with lumbosacral radicular pain.

RCT Entities:   Population Interventions Outcomes