Saturday, September 3, 2016

My Aching Back: Spinal Fusion & Treatment Scores

There is controversy in the medical community about the usefulness of spinal fusion surgery for chronic low back pain. If you’re a patient in an area where there are a lot of spine surgeons, you’re much more likely to get surgery than if you live in area where there are fewer surgeons.  I’ve heard from surgeons about desperate patients who have tried everything else and they do get better with surgery, but there are several reviews out there questioning the efficacy of spinal fusion for treatment of chronic low back pain. It’s time to take a look at some Treatment Scores.

To be clear, we’re talking about patients with chronic low back pain, not patients with acute low back pain, nerve compressions, or spinal stenosis. Our outcome measure will be a decrease in disability, specifically the Oswestry disability index, as this was the outcome used in the studies I found.  We are not using pain since this was not the main outcome in the studies. In most cases, if the disability index decreases so does the pain level.

I found three randomized controlled trials that compared surgical intervention (specifically spinal fusion) to non-surgical intervention. The best study would be a comparison of surgical intervention vs. sham surgery vs. placebo. As we saw from the studies on vertebroplasties, sham surgeries can have a powerful placebo effect.  However, the only studies done were comparing surgical to non-surgical groups. It is difficult to do sham surgeries, although they have been done for some procedures.  Nevertheless, the purpose of Treatment Scores is to figure out what we know and what we don’t know about a particular topic so we’ll proceed on.

In all of the studies, there was a decrease in the Oswestry disability index (ODI) in the non-surgical group and in the surgical group. The decrease was greater in the surgical group in every case.  We’ll use the percent decrease in the ODI in the surgical group minus the percent decrease in the OSI in the non surgical group. The differences in the three studies were 19%, 8%, and 8%. The non-surgical groups were not the same. In one of the studies the patients had physical therapy. In two of the studies the patients had cognitive therapy along with physical therapy. The group that did not have cognitive therapy had the largest difference in the OSI.

It should also be noted that these were intention to treat studies meaning that some of the patients assigned to the non-surgical group ended up having surgery and this was a significant number in some of the studies. For example, in one study 28% of the patients assigned to the non-surgical group did have surgery within two years and 4% assigned to the surgical group did not have surgery.
Another issue that has to be considered is the MCIC or minimal clinically important change.  This is probably around 10 to 15 for the ODI. The differences in these studies are either below or at the border of clinical significance.

Also, there was another study which should be mentioned. It was a cohort study following groups of patients who had fusion vs those who did not. Since it is a cohort study, it cannot rank as high as randomized trials, but it was a well done cohort study. They found that patients who did not have surgery were 40% more likely to return to work than patients who did have surgery.

In this essay, I won’t go into all of the details of how I calculated my Treatment score. As mentioned in other blogs, the Treatment Score is the gross treatment benefit minus side effects plus side benefits. There is subjectivity in coming up with the final Treatment Score due to some of the uncertainties in the studies and side effects that have to be taken into account. (We will decrease subjectivity with mathematics and programming as we move forward). The side effects have to be rescaled, estimated, and subtracted from the gross treatment benefit. One study listed a complication rate of 18%. Others had lower complication rates. Complications included death, wound infections, deep venous thrombosis, pulmonary embolus, tears of the dura, need for re-operation and nerve injury. It does seem apparent, that with the current data, spinal fusion cannot have a high Treatment Score compared to non-surgical groups. My Treatment Score is 6 as shown in the Treatment Score Calculator™ below:


A Treatment Score of 6 has a letter grade of E.

To sum up, here is what we know. There is a decrease in disability with spinal fusion for the treatment of chronic low back pain. However, the Treatment Score is low compared to non-surgical groups. It appears to be lower than the MCIC ( minimal clinically important change). The groups who had cognitive therapy along with physical therapy tended to do better.

Here’s what we don’t know. There is still uncertainty since spinal fusion has never been compared to sham surgery. Some of the patients who were in the non-surgical group did have surgery. We don’t know if this would have changed the outcome more in favor of spinal fusion if they did not cross over.

This is what Treatment Scores is about. We know what we know, what we don’t know and what we need to find out. There is a simple Treatment Score for each treatment that patients and medical professionals can understand. (See the disclaimers below.)

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