Epidural Lavage Study

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.

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