Spine Patient Outcomes Research Trial (SPORT): Spinal Stenosis
2 other identifiers
interventional
289
1 country
13
Brief Summary
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. Low back pain is one of the most widely experienced health problems in the United States and the world. It is the second most frequent condition, after the common cold, for which people see a doctor or lose days from work. 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) with a type of surgery known as posterior decompressive laminectomy or with nonsurgical methods. This study does not cover the cost of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2000
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedStudy Start
First participant enrolled
March 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedAugust 4, 2015
August 1, 2015
15.1 years
November 3, 1999
August 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in health-related quality of life as measured by the SF-36 health status questionnaire
Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Secondary Outcomes (4)
Patient satisfaction with treatment
Baseline, 6 wks, 3 mos, Annually thereafter
utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness
Baseline, 1 yr, 4 yr
resource utilization
Baseline, 6 wks, 3 and 6 mos, Annually thereafter
cost
Baseline, 6 wks, 3 and 6 mos, Annually thereafter
Study Arms (2)
Surgery
ACTIVE COMPARATORDecompressive laminectomy
Non-surgical treatments
ACTIVE COMPARATORActive physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
Interventions
Removal of the hypertrophic inferior and superior articular facets will be performed when they are intruding upon the midline and causing both central and lateral recess stenosis.
Active physical therapy modality, Education/Counseling with home exercise instruction, and an NSAID if tolerated
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Kaiser Permanente Spine Care Program
Oakland, California, 94612, United States
University of California, San Francisco (UCSF)
San Francisco, California, 94143-0728, United States
Emory University, The Emory Clinic
Decatur, Georgia, 30033, United States
Rush-Presbyterian, St. Luke's Medical Center
Chicago, Illinois, 60612-3833, United States
Maine Spine & Rehabilitation
Scarborough, Maine, 04074, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073-9952, United States
Washington University
St Louis, Missouri, 63110, United States
Nebraska Foundation for Spinal Research
Omaha, Nebraska, 68154-4438, United States
Dartmouth-Hitchcock Medical Center - Spine Center
Lebanon, New Hampshire, 03756, United States
New York University, The Hospital for Joint Diseases
New York, New York, 10003, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Rothman Institute at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-4216, United States
Related Publications (11)
Birkmeyer NJ, Weinstein JN, Tosteson AN, Tosteson TD, Skinner JS, Lurie JD, Deyo R, Wennberg JE. Design of the Spine Patient outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2002 Jun 15;27(12):1361-72. doi: 10.1097/00007632-200206150-00020.
PMID: 12065987BACKGROUNDWeinstein JN, Brown PW, Hanscom B, Walsh T, Nelson EC. Designing an ambulatory clinical practice for outcomes improvement: from vision to reality--the Spine Center at Dartmouth-Hitchcock, year one. Qual Manag Health Care. 2000 Winter;8(2):1-20. doi: 10.1097/00019514-200008020-00003.
PMID: 10787504BACKGROUNDFanciullo GJ, Hanscom B, Weinstein JN, Chawarski MC, Jamison RN, Baird JC. Cluster analysis classification of SF-36 profiles for patients with spinal pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2276-82. doi: 10.1097/01.BRS.0000084880.33281.EB.
PMID: 14520044BACKGROUNDLurie JD, Birkmeyer NJ, Weinstein JN. Rates of advanced spinal imaging and spine surgery. Spine (Phila Pa 1976). 2003 Mar 15;28(6):616-20. doi: 10.1097/01.BRS.0000049927.37696.DC.
PMID: 12642771BACKGROUNDWalsh TL, Hanscom B, Lurie JD, Weinstein JN. Is 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. Spine (Phila Pa 1976). 2003 Mar 15;28(6):607-15. doi: 10.1097/01.BRS.0000050654.97387.DF.
PMID: 12642770BACKGROUNDWeinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
PMID: 18287602RESULTWeinstein JN, Tosteson TD, Lurie JD, Tosteson A, Blood E, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H. Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial. Spine (Phila Pa 1976). 2010 Jun 15;35(14):1329-38. doi: 10.1097/BRS.0b013e3181e0f04d.
PMID: 20453723RESULTTosteson AN, Lurie JD, Tosteson TD, Skinner JS, Herkowitz H, Albert T, Boden SD, Bridwell K, Longley M, Andersson GB, Blood EA, Grove MR, Weinstein JN; SPORT Investigators. Surgical treatment of spinal stenosis with and without degenerative spondylolisthesis: cost-effectiveness after 2 years. Ann Intern Med. 2008 Dec 16;149(12):845-53. doi: 10.7326/0003-4819-149-12-200812160-00003.
PMID: 19075203RESULTTosteson AN, Tosteson TD, Lurie JD, Abdu W, Herkowitz H, Andersson G, Albert T, Bridwell K, Zhao W, Grove MR, Weinstein MC, Weinstein JN. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Nov 15;36(24):2061-8. doi: 10.1097/BRS.0b013e318235457b.
PMID: 22048651RESULTDesai A, Ball PA, Bekelis K, Lurie J, Mirza SK, Tosteson TD, Weinstein JN. SPORT: Does incidental durotomy affect longterm outcomes in cases of spinal stenosis? Neurosurgery. 2015 Mar;76 Suppl 1(0 1):S57-63; discussion S63. doi: 10.1227/01.neu.0000462078.58454.f4.
PMID: 25692369DERIVEDDesai A, Ball PA, Bekelis K, Lurie J, Mirza SK, Tosteson TD, Weinstein JN. SPORT: does incidental durotomy affect long-term outcomes in cases of spinal stenosis? Neurosurgery. 2011 Jul;69(1):38-44; discussion 44. doi: 10.1227/NEU.0b013e3182134171.
PMID: 21358354DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James N. Weinstein, DO, MS
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
March 1, 2000
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 4, 2015
Record last verified: 2015-08