Ben Franklin once said that the only things that are certain are death and taxes, but a close runner-up is this: in your lifetime, you will likely experience at least one incident of serious lower back pain. In fact, over 80% of Americans have a major lower back pain event during their lifetime and it is the second most common reason to go to the doctor in the U.S. Stand down, Star Spangled Banner; our new national anthem, sung as you try to get out of bed in the morning, is, “Oy, my back is killing me!”
Considering that back pain is nearly as common as the common cold, and despite the fact that over $85 billion is spent in the U.S. every single year on diagnosing and treating back pain, the state of medicine in this area hasn’t come much further than crossing your fingers and wishing on a star when it comes to effective outcomes. Truth be told, most physicians will tell you that whatever the cause of your pain, the odds are that it will resolve itself within about 6-8 weeks with some combination of rest, basic stretching exercises and over-the-counter anti-inflammatory meds. Unfortunately they don’t tell you that until you have made a thoughtful contribution to their monthly Porsche payment fund, but it is basically the truth. However, after that 8 weeks is up, approximately 15% of the acute patients do not get any better and graduate to a different level of suffering: chronic low back pain.
The biggest problem with treating chronic back pain is the problem of effectively diagnosing it. There are myriad tests and customs used for that purpose, the vast majority of which tell you exactly nothing about the actual cause of back pain. Manual exams (the proverbial laying on of hands by doctors) is a highly imprecise science that reveals little of a concrete nature. Furthermore, while a very small minority of back pain cases can be traced to tumors, kidney disease and other very serious illnesses that could not be found without X-rays, CT and MRI scans, most of the time the Billions of dollars worth of imaging done annually to diagnose back pain tells you what a fortune-teller would have done for a fraction of the price and without the groovy purple curtains. You may see a bulged disk or an irregularity of the spine when you do one of these scans, but the problem is that those abnormalities of your anatomy may very well be unrelated to the physiological condition that is actually causing your lower back to make you walk around like Quasimodo. This is, by the way, a well-known fact in the field of medicine and yet it’s frequently ignored.
Truth is, if you have survived your teen years, college and your first marriage, you have a pretty good chance of having at least one ruptured disc in your back—it’s the price of living past 40. And just because it’s there doesn’t mean it hurts. The LA Times recently did an extensive multi-story piece about back pain and its treatments and one of the best quotes in it is this one from Dr. Heidi Prather, associate professor of physical medicine and rehabilitation in the department of orthopedic surgery at Washington University in St. Louis.
“If you went to 15 different doctors about your back pain, you’d get 18 different recommendations for treatment. That’s because some of them would give you more than one.”
You have a better chance of getting two economists to agree than two back surgeons, except that the back surgeons are likely to agree that while surgery may not help you get better (many estimate that 50% of all lower back surgeries fail to result in reduced pain), the surgery will help pay to put the surgeons’ children through college. This phenomenon is so common that they even have a name for it: Failed Back Surgery Syndrome. Can you imagine if that was the case in other medical specialties? You know what they called Failed Cardiac Surgery? Death.
In any event, lower back pain is most often caused by one of three things: disc problems, facet problems or muscle problems. Most of the time, when the treatment process starts, the treating physician does not really know which of these problems you have. Thus begins a cascade of trial and error medicine that should strike terror in the hearts of those who start down its path. First you get more scans than an Arab family at the airport. Next comes the ibuprofen (or stronger stuff if you’re Rush Limbaugh). Ok, harmless enough (unless you’re Rush Limbaugh) but also not usually helpful unless you like hallucinating while at work. Next up: the cortisone injections. Nope. Now the exploratory procedures, then the interventional ones. Hope you like jewelry, because you are going to be wearing a lot of metal, albeit on the inside where you can’t show it off.
People who have run this gauntlet have so many holes in them that you can use them as a very credible colander. Once in a while it works, but a very common outcome, sadly, is that 12 months after a process like this, you and your insurance company will have spent thousands to hundreds of thousands of dollars and you may still be swearing every time you try to tie your shoes.
“So what’s the problem? They can cure cancer,” you say, “what the hell?” What’s it going to take to properly diagnose back pain, much less properly match the treatment to the diagnosis so the patient actually feels better when it’s all said and done?
“Back pain is one of the most complicated problems in medicine,” says Dr. James Weinstein, professor of the evaluative clinical sciences and orthopedic surgery at Dartmouth Medical School, quoted in the LA Times piece. “It’s something I’ve been working on for 30 years, and I still don’t understand it.”
Interestingly, more venture capital investment is made in emerging orthopedic companies than in almost any other category of medical devices except cardiology; much of the investment in this area is targeted directly at solutions to spine-related issues, including lower back problems. With all that entrepreneurial spirit targeted at new high tech ways to treat the back, you would think that we’d see the kind of advances we do see in cancer detection and treatment. A key problem, however, is that very little of this investment has been made in actually figuring out how to better diagnose the back problem from the get-go in order to ensure an effective treatment regimen. Truth be told, the vast experience of back interventions have demonstrated that it is the low-tech that seems to reap the best results in pain management: walking, physical therapy, massage therapy, and Motrin.
As investors in medical technology, my firm had spent 10 years passing on deals focused on treating lower back pain because we didn’t feel that any we had seen could demonstrate a meaningful enough difference in quality of outcome, a key characteristic we look for in our investments, coupled with the ability to reduce healthcare costs. It wasn’t until Verium Diagnostics came along (note: used to be called SpineMatrix) that we got excited and here’s why: The company has developed a non-invasive way of reading the electrical impulses of the lower back to determine quite effectively whether the pain you feel emanates specifically from a disc, facet or muscle and which one exactly. Even better, Verium’s physician users have demonstrated that by having a highly specific differential diagnosis, one can utilize highly targeted physical therapy regimens and deliver dramatic reductions in back pain, even in patients that have had failed to get relief from previous physical therapy, pain management, surgeries – or a combination of all three.
Verium’s technology consists of an array the size of a dinner napkin that lays across the lower back and is attached to a machine that can read the electronic outputs your back sends when it is asked to do some small movements, such as lift a small item or bend a certain way. The physician receives what looks like a map of the back with the offending disc, facet or muscle clearly highlighted (usually it is sitting next to a volleyball named Wilson and holding a sign that says, “finally, you found me!”). What the array is actually doing is measuring the intensity of the various back muscles as they contract and then normalizing that information to account for body mass index. Muscle contraction in a specific area, also known as muscle recruitment, guards the back’s skeletal system to eliminate force load associated with lower back pain and back injury. By knowing exactly which of the 96 back muscles are contracting in an out-of-the-ordinary fashion, a clinician has specific information to better direct a treatment path with targeted physical therapy in order to provide a superior patient outcome.
Verium firmly believes that its products are best used by physicians who believe in applying non-invasive treatment approaches, such as physical therapy, before grabbing for the scalpel. Thus, they tend to work with orthopedists who have close connections to well-trained physical therapists who, armed with the specific cause of the actual back pain, can apply very focused, system-specific physical therapy interventions to determine whether anything more is needed for the patient to find relief.
The results of Verium’s most recent study surprised even us. Two groups of patients at Halifax Hospital in Florida were studied, although both of the groups suffered from chronic back pain that affected their functions of daily living—in other words, they were miserable from the pain they had every day. One set of patients was delineated as the
Physical Therapy Group and the other as the “Usual Treatment” or Comparative Group. Patients in both groups ran the gamut from no previous treatment for their condition, to (more often than not) a multiplicity of attempts to treat their chronic pain, including medicines (even the good Rush Limbaugh stuff), injections, surgeries—God knows, maybe even leeches.
Patients who presented for the study were randomly assigned to one of the two groups. Both groups were subjected to an initial medical evaluation and X-ray scan to provide a baseline for the study, and ensure nothing more serious was present that warranted immediate medical intervention (e.g., a spinal tumor or fracture). Patients in the Comparative Group were then sent back out into the ‘real world’ where providers not involved in the study delivered whatever course of treatment was “typical” for the physicians to provide. Typical interventions were generalized physical therapy, bracing, drugs, pain injections and even surgery (e.g., laminectomy, discectomy).
Patients in both groups were also given a Verium scan, called a CERSR scan (pronounced ‘cursor’, which stands for Computerized Electrophysiological Reconstruction of the Spinal Region). The difference was that for the Physical Therapy Group, those patients were continually managed by a single provider trained on the CERSR technology, and were directed toward a very highly targeted 4-8 week physical therapy regimen based on information from the CERSR scan. Each group was re-tested with another CERSR scan at Week 4 and Week 8 to provide an objective measure of progress, along with two standard patient reported outcomes measurements involving their level of pain and disability.
And the results? Well, as you can imagine I wouldn’t be telling this story if they were bad, but they were actually eyebrow-raisingly good. The Halifax study shows a 65% reduction of pain in the Physical Therapy Group compared to a 7.6% reduction in the Comparative Group. The reduction in the Oswestry Disability Index (“ODI”) was 51.1% in the Physical Therapy Group and only 5.8% in the Comparative Group. This is a dramatic reduction in the context of clinical literature, which considers an ODI reduction of 10% to be significant. FYI, the ODI (aka: Oswestry Low Back Pain Disability Questionnaire) is the gold standard tool that researchers and disability evaluators use to measure a patient’s permanent functional disability. The test has been in use for 25 years as the primary measurement tool to assess lower back function—the higher you are on the ODI on a scale up to 100, the more disabled you are as a result of your back pain.
And even though those assigned to the Physical Therapy Group had lived with debilitating back pain for months or even years despite pursuing a variety of ineffective treatments over that time, more than 75% of the patients from this group were successfully resolved by the end of the trial. In fact the vast majority of them were actually deemed successfully treated and discharged from care within 4 weeks of the start of targeted physical therapy. While there were a number of patients from the Physical Therapy group at the end of the study who were not considered successfully treated (several of these were legitimate surgical candidates that were affirmatively identified by the CERSR scan), by way of comparison only 16% of the patients from the Comparison group achieved a comparable level of improvement at the end of 8 weeks.
And to further gild the lily, the average cost of providing care to patients in the Physical Therapy Group was $5000 whereas patients in the Comparative Group racked up bills that were anywhere from $17,000 to $106,000. With the difference you could actually buy a whole Porsche outright. Better outcome, lower cost. Can I get a Hallelujah?
For those of you wondering whether this is a unique event that cannot be repeated, that doesn’t appear likely. Statistical analysis of the pilot study yielded strongly affirmative results, and Verium is already in the process of verifying the results at two other medical centers. The company is getting serious interest from physicians who have spent their careers truly dedicated to helping patients relieve their back pain to little avail. Despite my hard-won cynicism, it turns out that many back specialists are as frustrated as their patients by the incredibly poor outcomes associated with their traditional approaches to treating chronic back pain, even if they do have to pay for their Porsches. In a world where we cannot continue to pay for ever-increasing healthcare inflation, it is gratifying to see real advances that not only make a difference for patients, but also for wallets.