The Annals of Internal Medicine issued a “tip sheet” for journalists last week that a patient advocate for lower back pain believes contributes to medicalization, and may ultimately lead to overtreatment with costly and unproven therapies.
The tip sheet came in advance of a study published in this week’s issue of the highly respected journal.
The controlled study was performed at three French medical centers and was designed to test if injecting glucocorticoids (a type of steroid hormone) directly into the discs sandwiched between the vertebrae of the spine, would relieve pain. The study only enrolled individuals with chronic lower back pain who had not responded to pain medications or previous epidural injections, and who also showed imaging evidence of what are called “Modic 1” changes (inflammatory changes in the vertebral bones on each side of the disc).
Injecting an anti-inflammatory medication directly into the discs (“intradiscal” injection) is an uncommon, invasive and risky procedure that is not widely used for pain management. It is not the same as the much more commonly used “epidural injection,” which involves injecting a medication in the space around the spinal cord (the, so-called, “epidural space”). This distinction is important and was missed in this HealthDay story about the study.
The primary finding of the study was that those who received the injections were more likely than those in the control group to have less pain one month after the treatment. But this benefit did not hold past three months. The researchers concluded: “the rapid efficacy of [the injections] supports the role of local inflammation in the pathogenesis of symptoms related to active discopathy.” In other words, the authors imply that response to an anti-inflammatory drug somehow confirms that “active discopathy” (which would translate to “active disease of the disc”) is responsible for the pain.
But Mark Schoene, who has edited the The BackLetter newsletter for the past 23 years, doesn’t take issue so much with the study itself, as he does with this line from the Annals of Internal Medicine tip sheet:
“Active discopathy is associated with a specific phenotype of chronic low back pain. “
“That term ‘active discopathy’ is a new one for me, ” says Schoene, who adds it’s not a phrase you see in American medical journals. “A casual reader of this news release will come away with the impression that there is a new, valid reason to treat people with chronic low back pain (‘active discopathy’)—one that is supposedly identifiable with the combination of pain and evidence from imaging. But, in fact, there is a general consensus across the spine research community that imaging cannot identify pain in the low back at this point. Creating a new unproven treatment for low back pain is the essence of medicalization.”
And ‘phenotype’ is an odd word choice because it means “an observable physical appearance that is the result of the interaction between genetic characteristics and the environment.” So what is the observable phenomenon here? The inflammatory changes in the vertebral bodies that show up on MRI? Or is it the degenerated discs? (Which, by the way, most of us have after the age of 50.) And since there are no established genetic markers for chronic lower back pain, and the ‘environment’ in question here is undefined, one can’t help but wonder if the odd choice of ‘phenotype’ is either an attempt to add gravitas or something lost in translation.
I asked Dr. Christine Laine, the Editor-in-Chief of the Annals of Internal Medicine, what she thought of Mr. Schoene’s concerns. This was her email reply:
“It is theorized that the Modic I changes which were used to select patients for the study are related to low grade inflammation, but this is not something that is established and is a point of debate. The researchers chose this as an eligibility criteria attempting to select for patients most likely to respond to an anti-inflammatory therapy. However, this study showed that injecting steroids into the area of the changes didn’t actually help. The accompanying editorial sheds some insight on the issues that you are questioning.”
Well, the steroid injections did help, for one month. And Dr. Byron Schneider MD, who co-authored the accompanying editorial, says the short-lived pain relief brings up some important context:
“The study did a very good job of targeting their intervention in people with active inflammation. But it doesn’t mean these patients have chronic back pain because of these Modic 1 (inflammatory) changes. To imply that would be misleading. It is much more likely that this is a subgroup of patients who have chronic low back pain, after all, it took nearly three years to recruit the study subjects. So it’s a group with chronic lower back pain who probably incidentally had an acute episode with Modic 1 changes showing up on their MRI’s.”
Dr. Eugene Carragee is an orthopedic surgeon at Stanford University who has published extensively on back pain and disc interventions in particular. He has three major concerns with the study:
“First, it’s hard to get people to agree on the Modic classifications. Studies show that doctors have a hard time agreeing on what they see on the MRI, and what Modic number to give it. Second, is the steroid injection actually treating a specific condition, in a specific way, or is it providing a generalized or systemic sense of well-being? Finally, we’ve done studies showing that injecting discs with big needles — and the needles used in this study were bigger than the ones we studied — actually accelerates degeneration in the discs.”
The research raises other important questions. If this therapy only seems to provide short-term relief, and most acute back pain resolves on its own, is a a few weeks of relief worth the significant costs and risks of such an invasive procedure? And if intradiscal injections go from non-standard therapy to becoming popularized, could we see a wave of expensive and unproven therapies targeting spinal discs, as if they offer the answer to the incredibly complex world of chronic back pain?
It’s already happening. On the same day as the French study was published an orthopedic surgeon in Beverly Hills used a marketing company to announce “the first out-patient stem cell lumbar intradiscal injection.” It promises something far more alluring than the French study:
“Stem cell treatment replaces the old paradigm of living with the condition. Instead, the patient’s worn-out discs will heal and rebuild and supporting ligaments will strengthen. Chronic pain and suffering is eliminated and replaced by improved mobility and range of motion.”
But here is an important reality check: back pain is NOT a disease. It is a symptom. And even though it has dozens upon dozens of causes — made better or worse by a complex interplay of occupational, environmental and psychological factors — our default has become to approach it as a disease. Perhaps this is because millions of people suffer from it, or billions of dollars are to be made from it.
A study published three months ago by the Institute of Health Metrics and Evaluation (IHME) at the University of Washington looked at public and private spending in the US on all diseases in 2013. Back and neck pain treatments came in third at around $88 billion dollars. What came in first and second were two diseases: diabetes at just over $100 billion and ischemic heart disease at just over $88 billion (cancer was divided into 29 separate cancer types). Perhaps most remarkable was that spending on back and neck pain increased at a rate of over 6 percent a year; more specifically, jumping from $30 billion dollars in 1996 to the $88 billion mark in 2013.
Does Mark Schoene have a case when he says the Annals tip sheet contributes to medicalization? Yes, he does, if indeed the offending sentence in question (“Active discopathy is associated with a specific phenotype of chronic low back pain”) becomes parroted and perpetuated as it already has by some news articles like this one from the Daily Express. But, in fairness to the Annals of Internal Medicine, their tip sheet and the study they published, are a fairly subtle representation of a more far-reaching problem: the extreme medicalization of a symptom with an often reckless disregard for the consequences of overtreatment … the vast majority of which costs a lot of money, but has not proven to do a lot of good.
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