Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
Condition: Spinal Stenosis; Low Back Pain
MeSH terms: Spinal Stenosis; Back Pain; Low Back Pain; Constriction, Pathologic
Intervention: Epidural steroid with local anesthetic injection; Epidural local anesthetic injection; Epidural steroid injection; Epidural local anesthetic injection
Intervention description: Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.; Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.; Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.; Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Intervention MeSH terms: Dexamethasone; Betamethasone; Methylprednisolone Acetate; Lidocaine; Anesthetics, Local; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Epidural Steroid Injection; Low Back Pain; Spinal Stenosis; Elderly

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.
    

Eligibility criteria:

        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.