Wise Young
08-21-2001, 06:25 PM
Spine Patient Outcomes Research Trial- Intervertebral Disc Herniation
This study is currently recruiting patients.
Sponsored by
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)
Purpose
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. We will also track and observe an additional group of people who will not receive any treatment.
Condition Treatment or Intervention Phase Herniated Disc
Low Back Pain
Procedure:Discectomy
Procedure:Non-surgical treatments
Phase III
MEDLINEplusrelated topics:BackPain; SlippedDisk
Study Type:Interventional
Study Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study
Official Title:Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Intervertebral Disc Herniation (IDH)
Further Study Details:
Low back pain is considered one of the most widely experienced health problems in the United States and the world. This condition is the second most frequent condition, after the common cold, for which people 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 problem appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over non-surgical management.
The overall study is 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 first diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard non-surgical 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 use of health care. In this arm of the trial, we anticipate enrolling and randomly allocating a total of 500 participants. We will track an additional observational cohort to assess health and resource outcomes (1000 participants).
We will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus non-surgical interventions for IDH, SpS, and DS. On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of surgical versus non-surgical treatment for these three most commonly diagnosed lumbar spine conditions.
Eligibility
Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both
Participants: Patients
Criteria
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Expected Total Enrollment: 500
Location and Contact Information
Judi 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
California
University of California, San Francisco,San Francisco, California, 94143-0728, United States;Recruiting
Patricia Malone, R.N., M.S.N., A.N.P. 415-514-1509 malonep@orthosurg.ucsf.edu Serena Hu, M.D., Principal Investigator
Georgia
The Emory Clinic, Emory University,Decatur, Georgia, 30033, United States;Recruiting
Janet Warner, R.N. 404-778-7172 Janet_Warner@emory.org Scott Boden, M.D., Principal Investigator
Illinois
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 adavish1@rush.edu Gunnar Andersson, M.D., Ph.D., Principal Investigator
Michigan
William Beaumont Hospital,Royal Oak, Michigan, 48073-9952, United States;Recruiting
Noreen Hamill, R.N., B.S. 248-217-0528 nhamill@smtpgw.beaumont.edu Harry Herkowitz, M.D., Principal Investigator
Missouri
Washington University,St. Louis, Missouri, 63110, United States;Recruiting
Georgia Stobbs, R.N., B.A., A.A.S. 314-747-2817 stobbsg@msnotes.wustl.edu Lawrence G. Lenke, M.D., Principal Investigator
Nebraska
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 afredrichs@nebraskaspinecenter.com Michael Longley, M.D., Principal Investigator
New Hampshire
Dartmouth-Hitchcock Medical Center - Spine Center,Lebanon, New Hampshire, 03756, United States;Recruiting
Susan White, B.S. 888-794-2225 susan.j.white@dartmouth.edu William A. Abdu, M.D., Principal Investigator
New York
Hospital for Special Surgery,New York, New York, 10021, United States;Recruiting
Brenda Sherry, R.N., B.S.N. 212-774-2984 sherryb@hss.edu Harvinder Sandhu, M.D., Principal Investigator
New York
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 alex.lee@med.nyu.edu Thomas Errico, M.D., Principal Investigator
Ohio
Case Western Reserve University,Cleveland, Ohio, 44106, United States;Recruiting
Kathy Higgins, Ph.D., R.N., C.N.S. 216-844-8053 krh3@po.cwru.edu Sanford Emery, M.D., Principal Investigator
Pennsylvania
Rothman Institute at Thomas Jefferson Hospital,Philadelphia, Pennsylvania, 19107-4216, United States;Recruiting
Molly Reckner, R.N., B.S.N. 215-955-4987 mreckner@hotmail.com Todd Albert, M.D., Principal Investigator
Study chairs or principal investigators
James N. Weinstein, D.O., M.S., Principal Investigator Dartmouth Medical School
More Information
SPORT web site
Study ID Numbers NIAMS-004C; U01 AR45444
NLM Identifier NCT00000410
Date study startedMarch 2000; Date Study Completed June 2004 Record last reviewed March 2001
This study is currently recruiting patients.
Sponsored by
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)
Purpose
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. We will also track and observe an additional group of people who will not receive any treatment.
Condition Treatment or Intervention Phase Herniated Disc
Low Back Pain
Procedure:Discectomy
Procedure:Non-surgical treatments
Phase III
MEDLINEplusrelated topics:BackPain; SlippedDisk
Study Type:Interventional
Study Design:Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Efficacy Study
Official Title:Spine Patient Outcomes Research Trial (SPORT): A Multicenter Randomized Trial for Intervertebral Disc Herniation (IDH)
Further Study Details:
Low back pain is considered one of the most widely experienced health problems in the United States and the world. This condition is the second most frequent condition, after the common cold, for which people 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 problem appear to determine the rates of surgery. Despite these trends, there is little evidence proving the effectiveness of these therapies over non-surgical management.
The overall study is 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 first diagnostic group. The study will compare the most commonly used standard surgical treatments to the most commonly used standard non-surgical 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 use of health care. In this arm of the trial, we anticipate enrolling and randomly allocating a total of 500 participants. We will track an additional observational cohort to assess health and resource outcomes (1000 participants).
We will integrate data from the trial and observational cohorts to formally estimate the cost-effectiveness of surgical versus non-surgical interventions for IDH, SpS, and DS. On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of surgical versus non-surgical treatment for these three most commonly diagnosed lumbar spine conditions.
Eligibility
Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both
Participants: Patients
Criteria
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Expected Total Enrollment: 500
Location and Contact Information
Judi 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
California
University of California, San Francisco,San Francisco, California, 94143-0728, United States;Recruiting
Patricia Malone, R.N., M.S.N., A.N.P. 415-514-1509 malonep@orthosurg.ucsf.edu Serena Hu, M.D., Principal Investigator
Georgia
The Emory Clinic, Emory University,Decatur, Georgia, 30033, United States;Recruiting
Janet Warner, R.N. 404-778-7172 Janet_Warner@emory.org Scott Boden, M.D., Principal Investigator
Illinois
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 adavish1@rush.edu Gunnar Andersson, M.D., Ph.D., Principal Investigator
Michigan
William Beaumont Hospital,Royal Oak, Michigan, 48073-9952, United States;Recruiting
Noreen Hamill, R.N., B.S. 248-217-0528 nhamill@smtpgw.beaumont.edu Harry Herkowitz, M.D., Principal Investigator
Missouri
Washington University,St. Louis, Missouri, 63110, United States;Recruiting
Georgia Stobbs, R.N., B.A., A.A.S. 314-747-2817 stobbsg@msnotes.wustl.edu Lawrence G. Lenke, M.D., Principal Investigator
Nebraska
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 afredrichs@nebraskaspinecenter.com Michael Longley, M.D., Principal Investigator
New Hampshire
Dartmouth-Hitchcock Medical Center - Spine Center,Lebanon, New Hampshire, 03756, United States;Recruiting
Susan White, B.S. 888-794-2225 susan.j.white@dartmouth.edu William A. Abdu, M.D., Principal Investigator
New York
Hospital for Special Surgery,New York, New York, 10021, United States;Recruiting
Brenda Sherry, R.N., B.S.N. 212-774-2984 sherryb@hss.edu Harvinder Sandhu, M.D., Principal Investigator
New York
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 alex.lee@med.nyu.edu Thomas Errico, M.D., Principal Investigator
Ohio
Case Western Reserve University,Cleveland, Ohio, 44106, United States;Recruiting
Kathy Higgins, Ph.D., R.N., C.N.S. 216-844-8053 krh3@po.cwru.edu Sanford Emery, M.D., Principal Investigator
Pennsylvania
Rothman Institute at Thomas Jefferson Hospital,Philadelphia, Pennsylvania, 19107-4216, United States;Recruiting
Molly Reckner, R.N., B.S.N. 215-955-4987 mreckner@hotmail.com Todd Albert, M.D., Principal Investigator
Study chairs or principal investigators
James N. Weinstein, D.O., M.S., Principal Investigator Dartmouth Medical School
More Information
SPORT web site
Study ID Numbers NIAMS-004C; U01 AR45444
NLM Identifier NCT00000410
Date study startedMarch 2000; Date Study Completed June 2004 Record last reviewed March 2001