Status:
COMPLETED
Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute for Occupational Safety and Health (NIOSH/CDC)
Conditions:
Herniated Disc
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study tests the effectiveness of different treatments for the three most commonly diagnosed lumbar (lower) spine conditions. The purpose of the study is to learn which of two commonly prescribed ...
Detailed Description
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 whic...
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.
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00000410
Start Date
March 1 2000
End Date
April 1 2015
Last Update
August 4 2015
Active Locations (13)
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1
Kaiser Permanente Spine Care Program
Oakland, California, United States, 94612
2
University of California, San Francisco
San Francisco, California, United States, 94143-0728
3
The Emory Clinic, Emory University
Decatur, Georgia, United States, 30033
4
Rush-Presbyterian, St. Luke's Medical Center
Chicago, Illinois, United States, 60612-3833