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Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation Clinical research trials and Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation. Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation clinical trial. Subjects frequently obtain the most expert healthcare possible for their Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation  Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation
Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation
For Condition: Herniated Disc,Low Back Pain
Status: Recruiting
Sponsor(s): 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)
Synopsis: 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.
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. Overall, the SPORT 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 12 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 6 weeks, 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). Enrollment in the Observational cohort has been completed as of February 2003. 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 500
Location and Contact Information:
Overall Study Official:
JamesWeinstein, Principal Investigator, Dartmouth Medical School
Rothman Institute at Thomas Jefferson Hospital *Recruiting*
Philadelphia, Pennsylvania, 19107-4216
United States
Recruiting Carol Simon 267-339-3613
William Beaumont Hospital *Recruiting*
Royal Oak, Michigan, 48073-9952
United States
Recruiting Gloria Bradley 248-551-7901
Maine Spine & Rehabilitation *Recruiting*
Scarborough, Maine, 04074
United States
Recruiting Ellen Murphy 207-885-1455
The Emory Clinic, Emory University *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Sally Lashley 404-778-7172
Rush-Presbyterian, St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612-3833
United States
Recruiting Margaret Hickey 312-850-9179
University of California, San Francisco *Recruiting*
San Francisco, California, 94143-0728
United States
Recruiting Patricia Malone 415-514-1509
Case Western Reserve University *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Kathy Higgins (216) 844-8053
Nebraska Foundation for Spinal Research *Recruiting*
Omaha, Nebraska, 68154-4438
United States
Recruiting Nancy Fullmer 402-496-5513
Hospital for Special Surgery *Recruiting*
New York City, New York, 10021
United States
Recruiting Brenda Sherry 212-774-2984
Dartmouth-Hitchcock Medical Center - Spine Center *Recruiting*
Lebanon, New Hampshire, 03756
United States
Recruiting Barbara Butler-Schmidt 603-650-2590
New York University, The Hospital for Joint Diseases *Recruiting*
New York City, New York, 10003
United States
Recruiting Alex Lee 212-598-6114
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Georgia Stobbs 314-747-2817
Kaiser Permanente *Recruiting*
Oakland, California, 94611
United States
Recruiting Kristen Alderisio 510-752-5451
Additional Information:
Study ID Numbers: NIAMS-004C; U01 AR45444
Study Start Date: March 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000410
Other Herniated Disc Studies:
1. Magnets in the Treatment of Sciatica
2. Evaluating Yoga for Chronic Low Back Pain
3. Low Back Pain Patient Education Evaluation
4. Efficacy of Acupuncture for Chronic Low Back Pain
5. Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation
Related Studies:
Other Herniated Disc Clinical Trials
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Spine Patient Outcomes Research Trial (SPORT) - Intervertebral Disc Herniation
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