A very large study, the Spine Patient Outcomes Research Trial (SPORT) has recently concluded and found that both surgical and non-surgical treatments tend to help patients with pain from a lumbar herniated disc. Due to problems with the study design, however, it is difficult to say much more than that. Unfortunately, because the trial did not demonstrate that surgery is superior to non-surgical treatments for a lumbar herniated disc, there is new concern among spine physicians that insurance companies may now cite this study as "evidence" that surgery is not necessary.
Lumbar laminectomy or microsurgical discectomy for lumbar disc herniations is the most common spine operation performed in the United States. Although this operation has a long history of safety and reliability, there are large variations in the frequency of the procedure in the U.S. There have been several studies in the past that have compared non-surgical treatment of lumbar herniated discs with surgical treatment, but none have been on the scale of the recently released Spine Patient Outcomes Research Trial (SPORT). Published in the Journal of the American Medical Association in November, 2006, this study was coordinated by Dr. James Weinstein of the University of Vermont. It began in 2000, and included 13 different sites. 500 patients who agreed to participate in the study were randomized into either surgical vs. none surgical treatment arms.
The purpose of the study was to determine if there was either equivalence or superiority between the two types of treatment (surgery vs no surgery). The data were collected at multiple time intervals for 2 years and the two treatment arms were compared. Overall, both patient treatment groups had substantially improved by two years, and while there was a general tendency for the surgical group to do better, the differences between the two groups were not statistically significant.
Although the two groups fared roughly the same, the authors could not conclude that surgical and non-surgical outcomes were equivalent, because:
- 45% of the patients randomized to the no-surgery group switched to having surgery, and
- 40% who were randomize to the surgery group declined the surgery.
With this amount of crossover, it was difficult to draw any solid conclusion as to whether or not the two treatment options were equivalent or if one is superior.
The main problem with non-adherence to randomization and the crossover between groups is that there was a general tendency for patients with severe symptoms to choose surgery even though they had been randomized to the no-surgery group.
Patients who had been randomized to surgery and subsequently declined to proceed with surgery tended to have less severe symptoms. The authors also very wisely followed the patients who declined to be randomized during the two year follow up. These patients chose to have surgery at a better than 5:2 ratio. Basically, if a patient has severe symptoms and cannot manage their pain through non-surgical treatment options they will choose to proceed with surgery.
Both treatment options did eventually lead to satisfactory results in the majority of patients, so it can be concluded that a patient with leg pain due to a disc herniation can expect a favorable outcome. This study also was consistent with past studies in that surgery leads to a quicker resolution of symptoms. Lastly, both treatment options are relatively safe. The surgery group had no complications in 95% of the cases, and not having surgery did not lead to any episodes of serious neurological damage (e.g. cauda equina syndrome).
What patients can conclude from this study is that if they have pain from a disc herniation, trying non-surgical treatment is a reasonable option. If they can control their pain with non-surgical treatment options (medicines, injections, therapy, manipulation, etc...) continuing with this type of treatment is reasonable. If not, surgery is a reasonable option and can be expected to lead to quick and reliable resolution of the patient's symptoms.
For physicians, this study is useful in that it confirms that not all patients with leg pain (lumbar radiculopathy) from a lumbar disc herniation need surgery. It also confirms that surgery is safe and reliable for those patients who fail conservative treatment.
The real danger of a randomized controlled study of this magnitude that did not show superior results with the more expensive surgical treatment option, is the federal and private health care systems of this country may use this information to deny patients surgical treatment. Payors of all kinds are trying to ration care they will pay for based on "evidenced based" guidelines from the literature. What is not provided, however, by the literature is that not all diseases have the same severity. There was little stratification in this study as to severity of symptoms, and what little stratification there was showed a general tendency for patients with more severe symptoms to choose surgery, even when randomized to the no-surgery group.
In an effort to save money, payors would like to deny patients' requests for invasive interventions. They will claim the treatment is medically "unnecessary". Of course, they have not seen or examined the patient, and are simply following an algorithm. In our practice, we are already seeing insurance companies denying surgery for patients with severe leg pain due to a disc herniation unless they first have three epidural injections. We have observed that patients with a lot of tethering of their nerve root (a positive straight leg raise) actually have increased pain after trying to inject around the nerve root. I have also noted over the years that patients with a very shallow canal are less likely to benefit from non-surgical treatment. Patients who have already had their pain for several months can expect little benefit from an epidural injection. At any rate, there are always extenuating circumstances, and this should not be a decision made by the insurance company, but a decision made by the patient after consulting a spine expert. It would be a travesty if this very Herculean effort at a large research study such as the SPORT study was used to deny patients care that is beneficial in certain circumstances.