Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Nov 3, 1999

Keywords

ClinConnect Summary

Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. It is the second most frequent condition, after the common cold, for which patients see a physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the condition appear to determine the rates of su...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Duration of Symptoms: 12 or more weeks.
• • Treatments tried: Nonsteroidal anti-inflammatory medical therapy and physical therapy.
• • Surgical Screening: Pain in low back, buttocks, or lower extremity that becomes worse with lumbar extension. Must be confirmed by evidence of central or central-lateral compression of the cauda equina by a degenerative lesion of the facet joint, disc, or ligamentum flavum on MRI, computed tomography scans, or myelograms.
• • Tests: MRI to confirm diagnosis and level(s).
• Exclusion Criteria:
• • Previous lumbar spine surgery.
• • Not a surgical candidate for any of these reasons: Overall health that makes spinal surgery too life-threatening to be an appropriate alternative, patient has improved dramatically with conservative care, or the patient is unable (for any reason) to undergo surgery within 6 months.
• • Possible pregnancy.
• • Active malignancy: Patients with a history of any invasive malignancy (except nonmelanoma skin cancer) are ineligible unless they have been treated with curative intent AND have not had any clinical signs or symptoms of the malignancy for at least 5 years.
• • Current fracture, infection, and/or deformity (greater than 15 degrees of lumbar scoliosis, using Cobb measure technique) of the spine.
• • Age less than 18 years.
• • Cauda equina syndrome or progressive neurologic deficit (usually requiring urgent surgery).
• • Unavailability for followup (planning to move, no telephone, etc.) or inability to complete data surveys.
• • Symptoms less than 12 weeks.
• • Patient currently enrolled in any experimental "spine related" study.

Trial Officials