Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation

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 United States and the world. This condition is the second most frequent condition, after the common cold, for which people 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 problem appear to determin...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Duration of symptoms: 6 or more weeks.
• • Treatments tried: Non-steroidal anti-inflammatory medical therapy and physical therapy.
• • Surgical screening: Persistent radicular pain provoked by moderate exercise, sitting, increased abdominal pressure, decreased mobility, list (scoliosis), straight leg raising.
• • 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 which makes spinal surgery too life-threatening to be an appropriate alternative, dramatic improvement with conservative care, or inability (for any reason) to undergo surgery within 6 months.
• • Possible pregnancy.
• • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer) is ineligible unless he or she has been treated with a curative intent AND there has been no 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 neurological deficit (usually requiring urgent surgery).
• • Unavailability for follow-up (planning to move, no telephone, etc.) or inability to complete data surveys.
• • Symptoms less than 6 weeks.
• • Patient currently enrolled in any experimental "spine related" study.

Trial Officials