Table 3.

Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. Fairbank et. al. BMJ 2005.

Study Design	Multicenter randomized controlled trial.
Patients	349 participants
Inclusion Criteria	Age 18 to 55 with more than a 12 month history of chronic low back pain (with or without referred pain) who were considered spinal fusion candidates, including those with previous root decompression or discectomy.
Exclusion Criteria	Medical comorbidities precluding intervention, previous surgical stabilization surgery.
Treatments Compared	Lumbar spine fusion vs. an intensive rehabilitation program (based on cognitive therapy).
Loss to Follow-Up	Overall, 20% lost to follow-up at 24 months.
Outcome Measures	Primary: Oswestry disability index (ODI) and shuttle walking test at baseline and at two years. Secondary: Short form 36 general health questionnaire (SF-36) instrument, distress and risk assessment method (DRAM) including the modified Zung depression index and somatic perception questionnaire (psychological assessment)
Findings	Oswestry disability scores improved only slightly in favor of surgery with a mean difference of −4.1 (95% confidence interval −8.1 to −0.1, P = 0.045). There were no major differences between the two groups in any of the other outcome measures at 24 months.
Strengths	Relatively large, multicenter randomized controlled trial that used multiple outcome measures. Comprehensive, multidisciplinary, intensive rehabilitation program was used.
Weaknesses	The 20% loss to follow-up limited the internal validity of the study. There was some crossover between the intervention groups: 28% of patients randomized to rehabilitation had surgery by two years. 4% of subjects randomized to surgery had rehabilitation instead of surgery. Data were analyzed based on the intention to treat principle, so 28% of patients analyzed as receiving non-operative treatment actually had surgery. The difference in Oswestry scores between the interventions (4.1) just barely exceeded the 4 points specified in the sample size calculation, indicating a clinically small difference, though this treatment effect may have been decreased by the crossover. Furthermore, there was variation in the type of surgery performed since surgeons used their choice of procedure. No blinding of the trial research therapists. For some outcome measures, there were fewer subjects’ results at 24 months than anticipated by the initial sample size calculation (although the power was within range for the Oswestry measure) and the authors noted that they had fewer subjects enrolled than planned.
Bottom Line	Provides good evidence to suggest that intensive rehabilitation with a cognitive behavior component may be an alternative to spinal fusion surgery in the management of chronic low back pain. Almost ¾ of the patients randomized to rehabilitation avoided surgery by two years and had improvement in outcomes. The benefit of surgery was small and likely below the minimal clinically important difference, though the high crossover may have diluted the treatment effect. This should be considered in light of the potential risks and costs of surgery.