drugset / Trial / NCT01995461

Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis

NCT01995461 ↗

Terminated 26 enrolled Marshfield Clinic Research Foundation
NaSingle-groupOpen-labelSupportive care

Summary

The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS, particularly in patients whose level of stenosis is L4-5 or higher. However, these unilateral injections do not cross the midline, so in cases of lower extremity pain and symptoms on both sides, a bilateral TESI would probably be more beneficial. To date, there have not been any well designed prospective studies to determine the effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC. Therefore, the goal of this prospective, non-randomized case-series outcome study is to evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving function in patients with DLSS. The hypothesis is that BTESI at the level below the most stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and improves function in patients with DLSS.

Timeline

Start
2013-05
Primary completion
2014-06
Completion
2014-06

Outcome

Outcome not reported

Stopped: “biostatistician determined 20 subjects would be adequate to perform statistics”

Drugs

EvaluationDrugModalityDoseRoute
Background Dexamethasone Small molecule 10 mg Other
Background Lidocaine Other / unclassified 1 ml Other