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.