Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older
Brief Summary: The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.


Options:
A: 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.
B: Inclusion Criteria:

* At least 18 years of age
* History of chronic, function-limiting low back pain of at least 6 months duration
* Able to give voluntary, written informed consent to participate,
* Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up
* No recent surgical procedures within last three months

Exclusion Criteria:

* Cauda Equina symptoms and/or compressive radiculopathy
* Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine
* Uncontrolled major Depression or uncontrolled psychiatric disorder
* Uncontrolled or acute medical illnesses
* Chronic severe conditions that could interfere with outcome assessments
* Women who are pregnant or lactating
* Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
* Patients with multiple complaints involving concomitant hip osteoarthritis
* Inability to achieve proper positioning and inability to understand informed consent and protocol
* History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
C: Inclusion Criteria:

* Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
* Numerical Rating Scale leg pain score \> 4 (or if 3/10, greater or equal to back pain)
* MRI evidence of spinal pathology consistent with symptoms

Exclusion Criteria:

* Untreated coagulopathy
* Previous spine surgery
* No MRI study
* Leg pain \> 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation.

Pregnancy
D: Inclusion Criteria:

1. Chronic low back pain of radicular origin of \> 4 weeks but \< 6 months duration.
2. Leg pain \> back pain.
3. Failure of conservative therapy to include physical and pharmacotherapy.
4. MRI evidence of a lateral or paracentral herniated disc corresponding to the patient's radicular symptoms.

Exclusion Criteria:

1. Uncontrolled coagulopathy.
2. Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age.
3. Allergy to contrast dye or amide local anesthetics.
4. Previous epidural steroid injection within last year.
5. Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response.
6. Rheumatoid arthritis or spondylarthropathy.
7. Unstable neurological condition (e.g. multiple sclerosis)
8. Systemic infection

Answer: A