Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)

Lumbar spinal stenosis is one of the most common causes of low back pain in the elderly and
can lead to significant disability. The symptoms of spinal stenosis range from low back pain
to neurogenic claudication with lower extremity pain, weakness and/or sensory changes related
to activities. As spinal stenosis can affect the central canal as well as the lateral
recesses and intervertebral foramen variably, symptoms can involve single or multiple
myotomes and dermatomes. Since the causes of spinal stenosis are most frequently degenerative
changes, the symptoms of spinal stenosis often, but not always, worsen over time. Despite the
prevalence of spinal stenosis, treatment of spinal stenosis remains somewhat controversial.
Common treatments include conservative measures such as non-steroidal anti-inflammatories
(NSAIDS), activity modification and physical therapy as well as more invasive treatments such
as epidural steroid injections and surgery. Although surgery has been demonstrated to provide
some benefit to many individuals with spinal stenosis, ESI are being used with increasing
frequency as a less invasive, potentially more cost effective and safer treatment for spinal
stenosis. However, there is a lack of data to demonstrate the effectiveness and safety of
epidural steroid injections for spinal stenosis, particularly in the older adults.

Because of the compelling need for effective therapy for patients suffering from spinal
stenosis and because epidural steroid injections are rapidly becoming standard of care for
treating these patients - even in the absence of compelling clinical evidence - we are
conducting a randomized, controlled trial in order to test the hypothesis that lumbar
epidural steroid injections improve functional status and pain associated with spinal
stenosis. The main objective of the study is to conduct a blinded, randomized controlled
trial (RCT) in elderly patients with spinal stenosis to test if the effectiveness of epidural
steroid injections (ESI) plus local anesthetic (LA) is greater than LA alone.

Inclusion Criteria:

1. Pain in the low back, buttock, and/or lower extremity (pain NRS>=5) with standing,
walking and/or spinal extension (buttock/leg>back pain).

2. Modified Roland-Morris score of at least 7.

3. Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified
by MRI or CT scan.

4. Lower extremity symptoms consistent with neurogenic claudication.

5. Must be able to read English and complete the assessment instruments.

6. Age 50 or older.

Exclusion Criteria:

1. Cognitive impairment that renders the patient unable to give informed consent or
provide accurate data.

2. Clinical co-morbidities that could interfere with the collection of data concerning
pain and function.

Known dx of fibromyalgia, chronic widespread pain, amputees, parkinsons, head injury,
dementia, stroke, other neurologic conditions Collect date about cervical spinal
stenosis, painful peripheral neuropathy, EMGs

3. Severe vascular, pulmonary or coronary artery disease that limits ambulation including
recent myocardial infarction (within 6 months).

4. Spinal instability requiring surgical fusion.

5. Severe osteoporosis as defined by multiple compression fractures or a fracture at the
same level as the stenosis.

6. Metastatic cancer.

7. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.

8. Possible pregnancy or other reason that precludes the use of fluoroscopy.

9. Concordant pain with internal rotation of the hip (or known hip joint pathology).

10. Active local or systemic infection.

11. Abnormal coagulation.

12. Allergy to local anesthetic, steroid or contrast.

13. Previous lumbar spine surgery.

14. Epidural steroid injection within previous 6 months.