Spine Research: Enhancing or Impeding the Quality of Surgical Decision-Making?

April 18, 2015

I recently reviewed a randomized clinical trial (RCT) that got my attention. Randomizing low back as well as cervical pain patients to either surgery or non-surgery has become a common and attractive study design ever since the National Institute of Health justified funding the SPORT trial ten years ago to the tune of $18 million. After all, isn’t that a crucial decision in spine care worthy of an $18 million investment – whether to operate or treat conservatively?

But there are inherent problems with this study design. It simply isn’t generalizable to real-life practice because non-surgical care always precedes surgery. Non-surgical care and surgery are sequential, not concurrent. Surgery isn’t indicated until non-surgical care has been exhausted and failed to adequately help the patient. Obviously no patient wants surgery if able to recover without it.

The real life decision is when to operate, not which is better? Surgery is never a good choice if there is still a non-surgical treatment worthy of trial.

So there are two related problems with investigating this research question of which is better. First, what constitutes sufficient failed non-surgical care that qualifies a patient to be a surgical candidate and therefore a candidate for such a study?

Consider that primary care physicians commonly refer to spine surgeons simply because the patient has a radiculopathy and needs an MRI, or already has an MRI showing a herniated disc. The surgeon is viewed as the spine expert who is better able to guide care, including appropriate diagnostics, non-surgical care, and then perhaps even surgery. A patient should not be a surgical candidate simply because (s)he is referred to a surgeon or because a certain amount of time has passed. These were the two inclusion criteria defining sufficient non-surgical care in this recent RCT I reviewed.

But there’s a second related problem. A critical question in these studies is never asked: what conservative care has each patient had prior to randomization? It’s never asked because it’s often not asked by spine surgeons during their routine patient care who assume that the referring doc has already exhausted conservative care.  But surgeons should evaluate whether each patient has had sufficient, or the right form(s) of, non-surgical care before recommending surgery.  Again, that aspect of each patient’s history is typically ignored but should be part of the baseline data gathered in all these studies.

Without that pre-study non-surgical care information, some, perhaps many, are randomized to conservative care that had previously failed to help. Would we randomize one of these subjects to surgery who had previously undergone failed surgery? No, we’d likely exclude them altogether, but we’d at least be sure they’re not randomized to the same surgical procedure that has already failed. So to avoid randomizing subjects to care that has already failed, RCTs need to document the type of conservative care each patient had undergone prior to randomization.  But again, if there is more conservative care that might be helpful, why are they even considered a surgical candidate to meet inclusion criteria?

Meanwhile, as has been posted prominently in my blogs, there is strong evidence that eliciting the two clinical findings of directional preference and pain centralization indicates that a patient is NOT a surgical candidate because recovery is so predictable with appropriate directional treatment. These two findings are commonly identified across the a wide spectrum of painful spinal conditions: acutes, chronics, axial and referred pain, radiculopathies, stenotics with pseudo-claudication, spondyloytic and -listhesis patients.

The goal of these RCTs is presumably to improve surgical decision-making. But to avoid a variety of unnecessary surgery, every spinal pain patient should undergo a mechanical evaluation that tests for directional preference and pain centralization before considering surgery. Otherwise, surgery is commonly performed for patients with an undiscovered directional preference.  Of course, that exam needs to be performed by a well-trained McKenzie clinician to determine if the disorder is mechanically reversible.

So tell me below what you think or ask what questions you have.

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