Low back pain is considered one of the most widely experienced health problems in the U.S. and the world. This condition is second only to the common cold as the condition for which patients most frequently see a physician or suffer days lost from work. Estimated costs to those who are severely disabled from low back pain range from 30-70 billion dollars annually. Rates of spinal surgery in the U.S. have increased sharply over time, and 15-fold geographic variation in rates of these surgeries has been documented. In many cases the rates of surgery appear to be determined by where one lives and who one sees. Despite these trends, there is little evidence proving the effectiveness/efficacy of these therapies over non-operative management. This study will use the unique resource of the National Spine Network to conduct multicentered, randomized, controlled trials 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 spondylolithesis (DS). The trials will compare the most commonly used standard surgical treatments to the most commonly used standard non-operative treatments. The study will be conducted at 16 sites throughout the United States. The primary endpoints of the study will be changes in general health-related quality of life as measured by the SF-36 health status questionnaire and spine-related disability as measured by the Oswestry Low Back Pain questionnaire. Secondary endpoints will include patient satisfaction with treatment, resource utilization for estimation of cost, and utility for current health for estimation of quality-adjusted life years (QALYs). The latter two endpoints will be used to complete a formal cost-effectiveness evaluation. Patients will be followed a minimum of 24 months with visits scheduled at 3, 6, 12, and 24 months. Data on all endpoints will be collected at each study visit. If possible, extended follow-up visits will be scheduled at 36 and 48 months. We anticipate that a total of 1450 subjects will be enrolled and randomly allocated. An additional observational cohort will be tracked to assess health and resource outcomes. Data from the RCT and observational cohorts will be integrated to formally estimate the cost-effectiveness of operative versus non-operative interventions for IDH, SpS, and DS. Based on this trial we will, for the first time, have scientific evidence as to the relative effectiveness/efficacy of surgical versus non-surgical treatment for these three common lumbar spine conditions.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AR045444-02
Application #
6171144
Study Section
Special Emphasis Panel (ZAR1-AAA-C (J3))
Program Officer
Panagis, James S
Project Start
1999-07-04
Project End
2004-05-31
Budget Start
2000-06-01
Budget End
2001-05-31
Support Year
2
Fiscal Year
2000
Total Cost
$3,430,132
Indirect Cost
Name
Dartmouth College
Department
Family Medicine
Type
Schools of Medicine
DUNS #
041027822
City
Hanover
State
NH
Country
United States
Zip Code
03755
Skolasky, Richard L; Scherer, Emily A; Wegener, Stephen T et al. (2018) Does reduction in sciatica symptoms precede improvement in disability and physical health among those treated surgically for intervertebral disc herniation? Analysis of temporal patterns in data from the Spine Patient Outcomes Research Trial. Spine J 18:1318-1324
Passias, Peter G; Poorman, Gregory; Lurie, Jon et al. (2018) Patient Profiling Can Identify Spondylolisthesis Patients at Risk for Conversion from Nonoperative to Operative Treatment. JB JS Open Access 3:e0051
Moulton, Haley; Tosteson, Tor D; Zhao, Wenyan et al. (2018) Considering Spine Surgery: A Web-Based Calculator for Communicating Estimates of Personalized Treatment Outcomes. Spine (Phila Pa 1976) 43:1731-1738
Abdu, William A; Sacks, Olivia A; Tosteson, Anna N A et al. (2018) Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976) 43:1619-1630
Suri, Pradeep; Pearson, Adam M; Zhao, Wenyan et al. (2017) Pain Recurrence After Discectomy for Symptomatic Lumbar Disc Herniation. Spine (Phila Pa 1976) 42:755-763
Gerling, Michael C; Leven, Dante; Passias, Peter G et al. (2017) Risk Factors for Reoperation in Patients Treated Surgically for Degenerative Spondylolisthesis: A Subanalysis of the 8-year Data From the SPORT Trial. Spine (Phila Pa 1976) 42:1559-1569
Thackeray, Anne; Fritz, Julie M; Lurie, Jon D et al. (2017) Nonsurgical Treatment Choices by Individuals with Lumbar Intervertebral Disc Herniation in the United States: Associations with Long-term Outcomes. Am J Phys Med Rehabil 96:557-564
Abdu, Robert W; Abdu, William A; Pearson, Adam M et al. (2017) Reoperation for Recurrent Intervertebral Disc Herniation in the Spine Patient Outcomes Research Trial: Analysis of Rate, Risk Factors, and Outcome. Spine (Phila Pa 1976) 42:1106-1114
Gerling, Michael C; Leven, Dante; Passias, Peter G et al. (2016) Risk Factors for Reoperation in Patients Treated Surgically for Lumbar Stenosis: A Subanalysis of the 8-year Data From the SPORT Trial. Spine (Phila Pa 1976) 41:901-9
Lurie, Jon D; Henderson, Eric R; McDonough, Christine M et al. (2016) Effect of Expectations on Treatment Outcome for Lumbar Intervertebral Disc Herniation. Spine (Phila Pa 1976) 41:803-9

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