|08-21-2001, 05:45 PM||#1|
Join Date: Jul 2001
Location: New Brunswick, NJ, USA
Spine Patient Outcomes Research Trial: Spinal Stenosis
Spine Patient Outcomes Research Trial: Spinal Stenosis
This study is currently recruiting patients.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute for Occupational Safety and Health (NIOSH/CDC) Office of Research on Women's Health (ORWH)
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.
Condition Treatment or Intervention Phase Spinal Stenosis
Low Back Pain
Procedure:Surgical posterior decompression laminectomy Procedure:Nonsurgical treatments
MEDLINEplusrelated topics:BackPain; SpinalStenosis
Study Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study
Official Title:Spine Patient Outcomes Research Trial (SPORT): A Multicenter Trial for Spinal Stenosis (SpS)
Further Study Details:
Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. It is the second most frequent condition, after the common cold, for which patients see a physician or lose days from work. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply over time, and researchers have documented 15-fold geographic variation in rates of these surgeries. In many cases, where one lives and who one sees for the condition appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over nonsurgical management.
This study will use the National Spine Network to conduct a multicenter, randomized, controlled trial for the three most common diagnostic groups for which spine surgery is performed: lumbar intervertebral disc herniation (IDH), spinal stenosis (SpS) and spinal stenosis secondary to degenerative spondylolisthesis (DS). This arm of the trial will deal with patients from the second diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard nonsurgical treatments. We will conduct the study at 11 sites throughout the United States.
The primary endpoint of the study will be changes in health-related quality of life as measured by the SF-36 health status questionnaire. Secondary endpoints will include patient satisfaction with treatment, utility for current health in order to estimate quality-adjusted life years (QALYS) as the measure for cost-effectiveness, resource use, and cost.
We will follow patients at 3, 6, 12, and 24 months to determine their health status, function, satisfaction, and health care use. We anticipate that we will enroll and randomly allocate a total of 370 study participants in this arm of the trial. We will track an additional observational cohort to assess health and resource outcomes.
We will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus nonsurgical interventions for IDH, SpS, and DS. The results of this trial will provide, for the first time, scientific evidence as to the relative effectiveness of surgical versus nonsurgical treatment for these three most commonly diagnosed lumbar spine conditions.
Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both
* 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).
* 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.
Expected Total Enrollment: 370
Location and Contact Information
Judi L. Forman, M.P.H. 603-650-2591 Judith.L.Forman@dartmouth.edu Susan J. White, B.S. 888-794-2225 Susan.J.White@dartmouth.edu
University of California, San Francisco (UCSF),San Francisco, California, 94143-0728, United States;Recruiting
Patricia Malone, R.N., M.S.N., A.N.P. 415-514-1509 firstname.lastname@example.org Serena Hu, M.D., Principal Investigator
Emory University, The Emory Clinic,Decatur, Georgia, 30033, United States;Recruiting
Janet Warner, R.N. 404-778-7172 Janet_Warner@emory.org Scott Boden, M.D., Principal Investigator
Rush-Presbyterian, St. Luke's Medical Center,Chicago, Illinois, 60612-3833, United States;Recruiting
Audrey Davis-Howard, R.N., M.P.A. 312-243-4244 email@example.com Gunnar Andersson, M.D., Ph.D., Principal Investigator
William Beaumont Hospital,Royal Oak, Michigan, 48073-9952, United States;Recruiting
Noreen Hamill, R.N., B.S. 248-217-0528 firstname.lastname@example.org Harry Herkowitz, M.D., Principal Investigator
Washington University,St. Louis, Missouri, 63110, United States;Recruiting
Georgia Stobbs, R.N., B.A., A.A.S. 314-747-2817 email@example.com Lawrence G Lenke, M.D., Principal Investigator
Nebraska Foundation for Spinal Research,Omaha, Nebraska, 68154-4438, United States;Recruiting
Anne Marie Fredrichs, M.S.N., R.N., C.P.N.P. 402-496-5513 firstname.lastname@example.org Michael Longley, M.D., Principal Investigator
Dartmouth-Hitchcock Medical Center - Spine Center,Lebanon, New Hampshire, 03756, United States;Recruiting
Susan J. White, B.S. 888-794-2225 Susan.J.White@dartmouth.edu William A Abdu, M.D., Principal Investigator
Hospital for Special Surgery,New York, New York, 10021, United States;Recruiting
Brenda Sherry, R.N., B.S.N. 212-774-2984 email@example.com Harvinder Sandhu, M.D., Principal Investigator
New York University, The Hospital for Joint Diseases,New York, New York, 10003, United States;Recruiting
Alex Lee, R.N., B.S.N. 212-598-6114 firstname.lastname@example.org Thomas Errico, M.D., Principal Investigator
Case Western Reserve University,Cleveland, Ohio, 44106, United States;Recruiting
Kathy Higgins, Ph.D., R.N., C.N.S. 216-844-8053 email@example.com Sanford Emery, M.D., Principal Investigator
Rothman Institute at Thomas Jefferson University,Philadelphia, Pennsylvania, 19107-4216, United States;Recruiting
Molly Reckner, R.N., B.S.N. 215-955-4987 firstname.lastname@example.org Todd Albert, M.D., Principal Investigator
Study chairs or principal investigators
James N. Weinstein, D.O., M.S., Principal Investigator Dartmouth Medical School
SPORT web site
Study ID Numbers NIAMS-004B; U01 AR45444
NLM Identifier NCT00000411
Date study started March 2000;
Date Study Completed June 2004
Record last reviewed March 2001