Low Back Pain Clinical Trial
Official title:
Spine Patient Outcomes Research Trial (SPORT): A Multicenter Trial for Spinal Stenosis (SpS)
Verified date | August 2015 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 289 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Rush-Presbyterian, St. Luke's Medical Center | Chicago | Illinois |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Emory University, The Emory Clinic | Decatur | Georgia |
United States | Dartmouth-Hitchcock Medical Center - Spine Center | Lebanon | New Hampshire |
United States | Hospital for Special Surgery | New York | New York |
United States | New York University, The Hospital for Joint Diseases | New York | New York |
United States | Kaiser Permanente Spine Care Program | Oakland | California |
United States | Nebraska Foundation for Spinal Research | Omaha | Nebraska |
United States | Rothman Institute at Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | University of California, San Francisco (UCSF) | San Francisco | California |
United States | Maine Spine & Rehabilitation | Scarborough | Maine |
United States | Washington University | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | National Institute for Occupational Safety and Health (NIOSH/CDC), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Research on Women's Health (ORWH) |
United States,
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. — View Citation
Fanciullo 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. — View Citation
Lurie JD, Birkmeyer NJ, Weinstein JN. Rates of advanced spinal imaging and spine surgery. Spine (Phila Pa 1976). 2003 Mar 15;28(6):616-20. — View Citation
Tosteson 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 spondylolisthe — View Citation
Tosteson 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 — View Citation
Walsh 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. — View Citation
Weinstein 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. Review. — View Citation
Weinstein 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 Outcome — View Citation
Weinstein 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. 2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Patient satisfaction with treatment | Baseline, 6 wks, 3 mos, Annually thereafter | No | |
Secondary | utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost effectiveness | Baseline, 1 yr, 4 yr | No | |
Secondary | resource utilization | Baseline, 6 wks, 3 and 6 mos, Annually thereafter | No | |
Secondary | cost | Baseline, 6 wks, 3 and 6 mos, Annually thereafter | No |
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