Clinical Question: Is intensive rehabilitation as effective as fusion of the lumbar spine to improve function in patients with chronic low back pain?
Setting: Outpatient (specialty)
Study Design: Randomized controlled trial (nonblinded)
Synopsis: In this study, researchers enrolled patients who were identified in 15 hospitals in the United Kingdom. They took an interesting approach to patient selection, enrolling 349 patients who were candidates for surgical stabilization of the spine, yet were uncertain (as were their physicians) whether surgery would be better than rehabilitation. The patients were 18 to 55 years of age and had had chronic low back pain for at least 12 months. The patients were randomized (allocation assignment may not have been concealed from the enrolling surgeon) to treatment with spinal fusion using a technique left to the discretion of the surgeon or to outpatient education and exercise five days per week for three weeks, with follow-up sessions at one, three, six, and 12 months. The rehabilitation program included stretching, spinal flexibility exercises, spinal stabilization exercises, aerobic exercise, and hydrotherapy. It also involved cognitive behavior therapy, which focused on identifying and overcoming fears and unwanted beliefs associated with low back pain.
Over the two years of the study, some crossover occurred, with 28 percent of patients in the rehabilitation group receiving surgery and 4 percent in the surgery group receiving rehabilitation. However, the patients were analyzed in the groups to which they were assigned originally (intention-to-treat analysis). Also, approximately 20 percent of patients were unavailable for the two-year follow-up.
At two years, scores on the Oswestry Disability Index (range: zero percent [no disability] to 100 percent [completely disabled]) improved slightly more in the surgically treated patients, from a baseline of 46.5 to 34.0, compared with a change in the rehabilitation group from 44.8 to 36.1, for an estimated mean difference between groups of 4.1 (95% confidence interval, 0.1 to 8.1;P = .045). There was no difference between the groups in the shuttle walking test, a progressive, maximal test of walking speed and endurance. Complications occurred in 11 percent of patients treated with surgery; there were no complications in the rehabilitation group. A study of the cost-effectiveness of spinal fusion compared with rehabilitation showed spinal surgery to cost $92,000 (U.S. dollars) per quality-adjusted life year, which is more expensive than interventions generally judged to be cost-effective (Rivero-Arias O, et al. Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial. BMJ May 28, 2005;330:1239–45)
Bottom Line: Intensive rehabilitation reduces disability caused by chronic low back pain, although it is slightly less effective than spinal fusion surgery. Rehabilitation is more cost-effective and results in fewer complications than surgery. (Level of Evidence: 1b–)