The Spine Patients Outcomes Research Trial was initiated to compare the outcomes of surgical and nonoperative treatment for lumbar intervertebral disc herniation, spinal stenosis, or degenerative spondylolisthesis. The trial included both a randomized cohort (n=501) and an observational cohort (n=743) that declined randomization in favor of self-selected treatment plans. All subjects met inclusion criteria.
This research trial was reported in two parts by James N. Weinstein, DO, MSc, and colleagues in November 2006. The research design and study outcomes generated two companion editorials, one of which described the study as a snapshot of patient preferences and clinical outcomes. Patients in both treatment groups improved substantially during the 2-year study period. In the randomized cohort, improvements were consistently in favor of surgery for all follow-up periods, though these improvements were small and lacked statistical significance. In the observational cohort, those who elected surgical intervention reported greater improvements than those who chose nonoperative care.
Real world patient behavior played a major role in study implementation and subsequent outcomes. Only 50% of patients randomized to surgical intervention actually received that treatment within 3 months of study enrollment. However, 30% of those assigned to nonoperative care received surgery in the same time period. Cross-over subjects had significant differences in terms of annual income, baseline symptoms, and levels of disability. Patient perceptions of worsening symptoms at trial entry predicted participation in the observational trial as well as elective surgery.
Standard care for nonoperative randomized patients was individualized, though the study design did not allow researchers to determine the efficacy of these alternatives. Eleven percent of patients receiving nonoperative treatments elected chiropractic manipulation; 44%, physical therapy; and 91%, nonsteroidal anti-inflammatory drugs, including cyclooxygenase-2 inhibitors.
Because of the study design and patient noncompliance to assigned treatments, the role and benefits of surgery remain unclear. Even so, this study makes a major contribution to the medical literature, raising important issues on study design (eg, sham surgical intervention). Regardless of the intervention received, most patients seemed satisfied with their medical care. Even in the randomized controlled trial, most subjects received the intervention they preferred. —F.J.R.
Weinstein JN et al. JAMA. 2006;296:2441-2450.
Weinstein JN et al. JAMA. 2006;296:2451-2459.