Design of the Spine Patient outcomes Research Trial (SPORT).
Nancy J O Birkmeyer, James N Weinstein, Anna N A Tosteson...
https://pubmed.ncbi.nlm.nih.gov/12065987Completed
Phase 4
Age: 18Years +
All Genders
ID00000410
Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Intervertebral Disc Herniation (IDH)
Led by Dartmouth-Hitchcock Medical Center · Updated on 2015-08-04
501
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Dartmouth-Hitchcock Medical Center
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 Site Locations
Total: 13 locations
1
Kaiser Permanente Spine Care Program
Oakland, California, United States, 94612
Status Unknown
2
University of California, San Francisco
San Francisco, California, United States, 94143-0728
Status Unknown
3
The Emory Clinic, Emory University
Decatur, Georgia, United States, 30033
Status Unknown
4
Rush-Presbyterian, St. Luke's Medical Center
Chicago, Illinois, United States, 60612-3833
Status Unknown
5
Maine Spine & Rehabilitation
Scarborough, Maine, United States, 04074
Status Unknown
6
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073-9952
Status Unknown
7
Washington University
St Louis, Missouri, United States, 63110
Status Unknown
8
Nebraska Foundation for Spinal Research
Omaha, Nebraska, United States, 68154-4438
Status Unknown
9
Dartmouth-Hitchcock Medical Center - Spine Center
Lebanon, New Hampshire, United States, 03756
Status Unknown
10
New York University, The Hospital for Joint Diseases
New York, New York, United States, 10003
Status Unknown
11
Hospital for Special Surgery
New York, New York, United States, 10021
Status Unknown
12
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Status Unknown
13
Rothman Institute at Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107-4216
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Designing an ambulatory clinical practice for outcomes improvement: from vision to reality--the Spine Center at Dartmouth-Hitchcock, year one.
J N Weinstein, P W Brown, B Hanscom...
https://pubmed.ncbi.nlm.nih.gov/10787504Cluster analysis classification of SF-36 profiles for patients with spinal pain.
Gilbert J Fanciullo, Brett Hanscom, James N Weinstein...
https://pubmed.ncbi.nlm.nih.gov/14520044Biologic treatment for intervertebral disc degeneration: summary statement.
Frank M Phillips, Howard An, James D Kang...
https://pubmed.ncbi.nlm.nih.gov/12897482Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36.
Thomas L Walsh, Brett Hanscom, Jon D Lurie...
https://pubmed.ncbi.nlm.nih.gov/12642770Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort.
James N Weinstein, Jon D Lurie, Tor D Tosteson...
https://pubmed.ncbi.nlm.nih.gov/17119141Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.
James N Weinstein, Tor D Tosteson, Jon D Lurie...
https://pubmed.ncbi.nlm.nih.gov/17119140Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT).
James N Weinstein, Jon D Lurie, Tor D Tosteson...
https://pubmed.ncbi.nlm.nih.gov/19018250The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT).
Anna N A Tosteson, Jonathan S Skinner, Tor D Tosteson...
https://pubmed.ncbi.nlm.nih.gov/18777603Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation.
Anna N A Tosteson, Tor D Tosteson, Jon D Lurie...
https://pubmed.ncbi.nlm.nih.gov/22048651