Overview

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

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Collaborators:
Dallas VA Medical Center
Harvard Pilgrim Health Care
Harvard Vanguard Medical Associates
Henry Ford Hospital
Kaiser Permanente
Massachusetts General Hospital
Mayo Clinic
Oregon Health and Science University
Stanford University
University of California, San Francisco
University of Colorado, Denver
Virginia Spine Research Institute
Treatments:
Anesthetics
Anesthetics, Local
BB 1101
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lidocaine
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
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.