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

Completed · Phase 4

Conditions studied: Herniated Disc, Low Back Pain

In brief

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 treatments (surgery and non-surgical therapy) works better for specific types of low back pain. In this part of the study, people with lumbar intervertebral disc herniation (damage to the tissue between the bones of the lower spine, or backbone) will receive either discectomy (surgical removal of herniated disc material) or non-surgical treatment. This study does not cover the cost of treatment.

Key facts

Study ID

NCT00000410

Run by

Dartmouth-Hitchcock Medical Center

People needed

501

Starts

2000-03-01

Expected to finish

2015-04-01

Last updated by the study team

2015-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente Spine Care Program — Oakland, California, United States
• University of California, San Francisco — San Francisco, California, United States
• The Emory Clinic, Emory University — Decatur, Georgia, United States
• Rush-Presbyterian, St. Luke's Medical Center — Chicago, Illinois, United States
• Maine Spine & Rehabilitation — Scarborough, Maine, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Nebraska Foundation for Spinal Research — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center - Spine Center — Lebanon, New Hampshire, United States
• New York University, The Hospital for Joint Diseases — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Rothman Institute at Thomas Jefferson Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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