Epidural Lavage Study for Lumbar Stenosis

Not Applicable

Completed

Conditions: Lumbar Spinal Stenosis

Interventions: Procedure: Epidural Steroid Injection with Lavage

Registration Number: NCT03511053

Lead Sponsor: Dallas VA Medical Center

Brief Summary: The purpose of this research is to find out if there are inflammatory biomarkers (also known as biological markers) in epidural space that can predict response to an epidural steroid injection. This study will also be evaluating whether the results of an EMG study (also known as electromyography) can predict the response to an epidural steroid injection.

Detailed Description: Lumbar spinal stenosis is a common cause of back pain and mobility impairment in older adults. It is often a multi-factorial condition resulting from degenerative changes in the spine, and may result in severe disability, with symptoms of lower back pain and/or pain, numbness and weakness of the lower extremities that are often exacerbated by walking and/or standing. Since lumbar spinal stenosis mostly stems from slowly progressive degenerative changes, symptoms often worsen over time, leading to poor health outcomes and high rates of healthcare utilization.

Epidural steroid injection (ESI) with anti-inflammatory compounds such as glucocorticoids is commonly provided to alleviate pain from neurogenic claudication in spinal stenosis: it is estimated that 25% of ESI's performed in the Medicare population and 74% of ESIs in the Veterans Affairs system are for spinal stenosis. However, one recent, large, multi-center, randomized controlled trial (RCT) demonstrated no significant benefit of epidural corticosteroids in alleviating symptoms of spinal stenosis. In this study, Friedly et al. conducted a double-blind, RCT comparing patient outcomes with epidural injection of glucocorticoid plus anesthetic (lidocaine) vs. anesthetic (lidocaine) only. No significant differences were observed at 6 weeks between the two groups of patients with respect to pain-related functional disability or pain intensity. However, a subset of patients who received glucocorticoids plus lidocaine reported significantly higher treatment satisfaction and higher reductions in depressive symptoms. This suggests that ESIs may be effective for a subset of patients with spinal stenosis.

Another treatment modality for spinal stenosis is decompression surgery, which may be effective for some patients but is associated with higher risk especially in the elderly and patients with multiple medical comorbidities. In Davis et al.'s observational study, in a two-year period with 68 patients, 32% of patients opted for surgery, 44% of patients were satisfied with non-surgical management and were discharged after 2 years, but the remaining 24% with non-surgical management (some of whom chose to decline surgery) did not seem to be satisfied with treatment. This study indicates the potential key role that non-surgical management options such as ESIs may play, in some patients. However, appropriate patient selection using indicators or biomarkers for patients who may most likely benefit from ESIs would be extremely beneficial.

In studying biomarkers that may predict patients' response to ESIs, Scuderi et al. found interferon-gamma (IFG) levels to have high predictive value for patients with lumbar nerve root irritation, while Golish et al. and Smith et al. found fibronectin-aggrecan complex (FAC) levels to have high predictive value for patients with herniated nucleus pulposus (HNP). In addition, many other factors (such as lower age and higher education) have been found to predict better outcome for radiculopathy. In particular, needle electromyography (EMG) has been shown in several studies to be a strong predictor for response to lumbar epidural steroid injection (LESI) and transforaminal epidural steroid injection (TESI) for patients with lumbosacral radiculopathy (LSR). Inspired by these studies, this study aims to explore if certain biomarkers such as IFG \& FAC along with EMG findings can help predict which patients with spinal stenosis and neurogenic claudication will optimally benefit from ESIs.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

Inclusion Criteria

Mild-severe lumbar central canal stenosis identified by MRI or CT scan
Symptoms:
Lower extremety symptoms consistent with neurogenic claudication
Pain, weakness and/or numbness triggered by standing or walking, and relieved by sitting
Must be able to read English and complete assessment instruments

Exclusion Criteria

Cognitive impairment that renders the patient unable to give informed consent or provide accurate data
Clinical co-morbidities that could interfere with the collection of data concerning pain and function
Severe vascular, pulmonary, or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months)
Spinal instability requiring surgical fusion
Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis
Metastatic cancer
Excessive alcohol consumption or evidence of non-prescribed or illegal drug use
Pregnancy
Concordant pain with internal rotation of the hip (or known hip joint pathology)
Active local or systemic infection
Abnormal coagulation
Allergy to local anesthetic, steroid, or contrast
Previous lumbar spine surgery
Prisoners
Epidural steroid injection within previous 6 months
Rheumatological disorders such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Epidural Steroid Injection with Lavage	Epidural Lavage followed by Lumbar Epidural Steroid Injection

Primary Outcome Measures

Name	Time	Method
Swiss Spinal Stenosis Questionnaire	Change between baseline, 1 month and 2 months post injection	Measures how pain due to spinal stenosis is effected the patient based on quality of life/pain questions and satisfaction questions for months 1 and 2 (no scales are used) SSSQ scores are reported in percentages 0-100%, higher scores indicate worse outcomes.
Visual Analogue Scale	Change between baseline, 1 month and 2 months post injection	Number rating of back/leg pain from 0 to 10, 0 being no pain/discomfort, 10 being extreme pain/discomfort
Pain Disability Questionnaire	Change between baseline, 1 month and 2 months post injection	Measures how pain is affecting the patients lifestyle on a scale from 0 to 10 as defined by each question. The questionnaire contains 15 questions that each range on a scale form 0 to 10. The total score of the questionnaire ranges from 0 to 150. Lower values represent a better outcome.