Low Back Pain: A Multi-Center Clinical Trial

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DESCRIPTION (provided by applicant): Low back related pain is a highly prevalent and costly health problem of major significance to national health policy. Estimated costs of disability from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply overtime, and 12-fold geographic variation in rates of these surgeries has been documented. However, little evidence documents the efficacy and cost-effectiveness of surgical therapy versus non-operative management. The broad objective of the Spine Patient Outcomes Research Trial (SPORT) has been to improve clinical decision making for surgical treatment of low back pain problems. SPORT represents the largest clinical investigation yet conducted of the three most common, disabling and costly low back disorders - intervertebral disc herniation (IDH), spinal stenosis (SpS), and degenerative spondylolisthesis (DS). SPORT'S three multi-center randomized controlled trials (RCTs) and associated observational cohorts compare quality of life outcomes for surgical vs. non-operative treatment. In addition to learning that surgery is an effective treatment for these 3 diagnoses, SPORT confirmed that many patients receiving non-operative treatment also do well, highlighting the importance of informed choice. Among the 2505 patients enrolled in SPORT, 91 have died and 1807 (75%) are actively in follow-up. SPORT III will continue to follow patients and gather long-term functional health, quality of life, and cost- effectiveness data. Our specific aims are: 1) To continue annual follow-up of all subjects for a minimum of 9 years; 2) To compare outcomes of surgical vs. non-operative treatment for low back pain as measured by the SF-36 health status questionnaire and the Oswestry Disability Index; 3) To determine long-term cost effectiveness as measured by societal health state values obtained via EuroQoL EQ-5D, and by subject- reported resource utilization and work productivity data. SPORT represents the largest and most diverse spine cohort established to date and constitutes a unique resource with extensive longitudinal data, a well-established clinical trial infrastructure, and high rates of follow-up. Extending the follow-up in these patients through a minimum of 9 years will provide important insights into the long-term outcomes and cost-effectiveness of treatment options in these common, debilitating and expensive conditions. As part of our ongoing efforts at dissemination, we will continue to develop web-based data resources and interactive software for patients, health care providers, and health policy makers seeking to translate the scientific results from SPORT into improved clinical practice. RELEVANCE (See instructions): Initial results from the Spine Patient Outcomes Research Trial (SPORT) found that for patients diagnosed with herniated disc, stenosis or degenerative spondylolisthesis, surgery resulted in better outcomes; however, non-operatively treated patients also did well highlighting the need for informed choice. Long-term follow-up in these unique cohorts is crucial to assess long-term outcomes and cost-effectiveness.