Surgical Versus Nonoperative Treatment for Lumbar Disc Herniation Four-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

Study Design. Concurrent, prospective, randomized, and observational cohort study. Objective. To assess the 4-year outcomes of surgery versus nonoperative care. Summary of Background Data. Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to nonoperative treatment remain controversial. Methods. Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective, randomized (501 participants), and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI -AAOS/Modems version) assessed at 6 weeks, 3 months, 6 months, and annually thereafter. Results. Nonadherence to treatment assignment caused the intent-to-treat analyses to underestimate the treatment effects. In the 4-year combined as-treated analysis, those receiving surgery demonstrated significantly greater improvement in all the primary outcome measures (mean change surgery vs. nonoperative; treatment effect; 95% CI): BP (45.6 vs. 30.7; 15.0; 11.8 to 18.1), PF (44.6 vs. 29.7; 14.9; 12.0 to 17.8) and ODI (Ϫ38.1 vs. Ϫ24.9; Ϫ13.2; Ϫ15.6 to Ϫ10.9). The percent working was similar between the surgery and nonoperative groups, 84.4% versus 78.4% respectively. Conclusion. In a combined as-treated analysis at 4 years, patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients in all primary and secondary outcomes except work status. Key words: SPORT, intervertebral disc herniation, surgery, nonoperative care, outcomes. Spine 2008;33:2789-2800 Lumbar disc surgery remains one of the most commonly performed operations, with rates exhibiting considerable geographic variation. 1 Two recent randomized trials demonstrated that surgery provides faster pain relief and perceived recovery in patients with herniated disc. 2-4 Outcomes were similar at 1 year for patients assigned to surgery and for those assigned to nonoperative treatment. However, both trials included substantial numbers of surgical patients in the nonoperative comparison arm due to treatment crossover, affecting the interpretation of the intent-to-treat analyses. This paper reports 4-year results for SPORT based on the continued follow-up of the herniated disc randomized and observational cohorts. Materials and Methods Study Design SPORT was conducted in 11 US states at 13 medical centers with multidisciplinary spine practices. The human subjects committees at each participating institution approved a standardized protocol for both the observational and the randomized cohorts. Patient inclusion and exclusion criteria, study interventions, outcome measures, and follow-up procedures have been reported previously. 3-5 Patient Population Men and women who had symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks, who had disc herniation at a corresponding level and side on imaging, and who were considered surgical candidates were eligible. The content of pre-enrollment nonoperative care was not prespecified in the protocol. 3-5 Specific enrollment and exclusion criteria are reported elsewhere

Report of the NIH Task Force on Research Standards for Chronic Low Back Pain

Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients’ lives. Such cLBP is often termed non-specific, and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. The NIH Pain Consortium therefore charged a Research Task Force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimal data set to describe research participants (drawing heavily on the PROMIS methodology); reporting “responder analyses” in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved the recommendations, which investigators should incorporate into NIH grant proposals. The RTF believes these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of chronic low back pain. We expect the RTF recommendations will become a dynamic document, and undergo continual improvement.Perspective: A Task Force was convened by the NIH Pain Consortium, with the goal of developing research standards for chronic low back pain. The results included recommendations for definitions, a minimal dataset, reporting outcomes, and future research. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes