The MRC spine stabilization trial

Study Design. A review of the surgical costs and results in a group of patients randomly allocated to surgery as part of a large prospective randomized trial of patients with chronic back pain. Objective. To report the observational data from the surgical arm of a randomized trial comparing surgery with intensive rehabilitation for chronic low back pain. Clinical and economic data are reported. Summary of Background Data. Surgery for chronic low back pain is a well established but unproven intervention. The most cost-effective technique for spinal stabilization is still not established. Methods. One hundred six patients with chronic low back pain were randomized to the surgical group of a randomized trial comparing spinal fusion of the lumbar with a 3 week intensive rehabilitation program. The primary outcomes were the Oswestry Disability Index (ODI) and the Shuttle Walking Test measured at baseline and 2 years postrandomization. Patients were stratified by preoperative diagnosis, smoking habit, and litigation. Complications were assessed and costs analyzed. Results. Of the 176 surgical patients, 56 underwent postern-lateral fusion, 57 underwent interbody fusion, and 24 underwent flexible stabilization of the spine. The mean ODI for all patients in the surgical arm of the trial improved from a baseline of 46.5 (SD 14.6) to 34.2 (SD 21) at 2 years. Health care costs were higher ( 3109 difference) for more complex procedures, and nearly 6 times as many early complications occurred with the more complex procedures. Smoking and unemployment were associated with worse results whereas litigation did not adversely affect the outcome. Conclusion. These observational changes in the ODI after surgery are similar to those reported from other studies of spinal fusion. More complex surgery is more expensive with more complications than postern-lateral fusion