NCT01995461

Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis

Effectiveness of Bilateral Transforaminal Epidural Steroid Injections in Degenerative Lumbar Spinal Stenosis Patients With Neurogenic Claudication: A Prospective Outcome Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Marshfield Clinic Research Foundation · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Interventions

Type	Name	Description
DRUG	bilateral transforaminal epidural steroid injections	BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-11-26
• Last updated: 2015-11-24
• Results posted: 2015-11-24

Locations

1 site across 1 country: United States