2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group.
This multicenter, randomized control trial out of Sweden was the 2001 Volvo Award Winner in Clinical Studies. Fritzell et al randomized 294 patients into a surgical treatment group (n=222) versus a non-surgical group (N=72). Patients were randomly assigned treatment and multiple validated outcome measures were utilized. The overall goal of the study was to define “if lumbar fusion could reduce pain and decrease disability more effectively than commonly recommended non-surgical treatment” for those with chronic low back pain.
Both groups had similar baseline characteristics in a number of measures including gender, smoking status, employment, and disability status. The surgical group was treated with either a posterolateral fusion, posterolateral fusion with screw fixation, or posterolateral fusion with screw fixation and interbody fusion. As there were no differences in outcomes, between the 19 treatment centers, the risk of bias was is less likely.
There are two concerns with this study. First and foremost, was the diagnosis of chronic low back pain. This was a very non-specific diagnosis and there was limited discussion about how this diagnosis was reached. Secondly, the non-operative group was treated with physical therapy but may have also been supplemented with other forms of treatment. There was no standardized protocol for treatment in this group.
One may argue that study results may be skewed as there were 25 patients who changed treatment groups during the course of the study. However, the authors applied an intent to treat analysis. Eighteen patient who changed from the surgical group into the nonsurgical group had results that were similar to those in the surgical group.
In regards to generalizability of this study, this was based on a Swedish population and treatment protocols (non-surgical) relied on Swedish standards at the time (2001). It is important to note that this study was funded by a grant from Acromed (Raynham, MA) and Ossano Scandinavica (Stockholm, Sweden).
Overall, this was a well organized randomized clinical trial that has scored relatively high (18 out of 20) using the Spineopedia scoring criteria. This study certainly has added value to the spinal literature and provided a basis for future study. However, generalizability may be limited based on the population studied, the non-specific diagnosis of chronic low back pain, and lack of standardized non-surgical treatment. Multiple meta-analysis have since been published looking at lumbar fusion and chronic low back pain including one in 2014 by Saltychev el al that concluded that lumbar fusion is not any more effective than non-surgical care in reducing perceived disability.