Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis

Completed · Phase 4

Conditions studied: Spondylolisthesis, Spinal Stenosis, Low Back Pain

In brief

This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain. In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips forward on another) with either surgery or nonsurgical methods. This study does not cover the cost of treatment.

Key facts

Study ID

NCT00000409

Run by

Dartmouth-Hitchcock Medical Center

People needed

304

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: 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).

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente Spine Care Program — Oakland, California, United States
• University of California, San Francisco (UCSF) — San Francisco, California, United States
• Emory University, The Emory Clinic — 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 University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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