Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis
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|ClinicalTrials.gov Identifier: NCT01995461|
Recruitment Status : Terminated (biostatistician determined 20 subjects would be adequate to perform statistics)
First Posted : November 26, 2013
Results First Posted : November 24, 2015
Last Update Posted : November 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Stenosis, Lumbar Region, With Neurogenic Claudication||Drug: bilateral transforaminal epidural steroid injections||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effectiveness of Bilateral Transforaminal Epidural Steroid Injections in Degenerative Lumbar Spinal Stenosis Patients With Neurogenic Claudication: A Prospective Outcome Study|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
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.
Other Name: BTESI
- Change From Baseline Pain Score at 6 Months [ Time Frame: baseline (pre-1st injection) to 6 months post-1st injection ]change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection
- Change From Baseline Swiss Spinal Stenosis Score at 6 Months [ Time Frame: baseline (pre-1st injection) to 6 months post-1st injection ]The Swiss spinal stenosis score is a questionnaire composed of 18 multiple choice questions designed to give information as to how the patient's back and leg pain is affecting their ability to manage everyday life. The Swiss spinal stenosis (SSS) questionnaire consists of 12 baseline questions asked of all participants prior to injection and an additional 6 questions asked at each time point post-treatment. The initial 12 questions assess reliability and condition at baseline while the 6 post-treatment questions assess treatment satisfaction. All questions ask the patient to assess symptoms over the previous month with a total maximum score for the initial 12 questions of 53 and a total maximum score of 24 for the 6 additional questions. The final total score is expressed as a percentage of the maximum possible score. Total score increases with worsening disability.
- Change From Baseline Oswestry Disability Index at 6 Months [ Time Frame: baseline (pre-1st injection) to 6 months post-1st injection ]The 2 questions from this Index pertaining to Standing and Walking are being utilized to assess changes in duration of standing and walking in these patients. The two sections of the Oswestry Disability Index (ODI) used in the present study were those related to walking and standing (sections 4 and 6). For each section, the total possible score is 5 and overall ODI score was expressed as a percentage of the maximum possible score (10). Total score increases with worsening disability.
- Change From Baseline Pain Medication Need/Use at 6 Months [ Time Frame: baseline (pre-1st injection) to 6 months post-1st injection ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995461
|United States, Wisconsin|
|Marshfield, Wisconsin, United States, 54449|
|Principal Investigator:||Mustafa Farooque, MD||Marshfield Clinic/MCRF|
|Principal Investigator:||James Burmester, PhD||Marshfield Clinic Research Foundation|