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A large study on the effectiveness of injections for spinal stenosis was published in the New England Journal of Medicine in July of this year. It was designed by top doctors in the field of pain management and funded by the Agency for Healthcare Research and Quality. The patients were carefully selected to have pain in their legs and clear evidence of narrowing of the spinal canal on MRI examinations. They were given an injection into the epidural space and were randomized to receive either an anti-inflammatory medication (corticosteroid) plus a local anesthetic medication (lidocaine) or just the lidocaine (which was considered a placebo as the effect is expected to wear off in a couple of hours).
Before the injections, the patients had significant leg and back pain, with average self-reported pain levels of 7 on a 10-point scale. Six weeks after the injections, their average pain level was reduced to 4.5, which is a significant drop, and suggests a good level of pain relief! However, the reduction occurred equally in both groups. The people who got the lidocaine injection obtained just as much pain relief as those who got the steroid injection. In other words, the placebo treatment worked just as well as the therapeutic injections.
What should we conclude from this study? Before answering that question, let’s review the relevant research from other studies on injection therapies for back pain and sciatic pain.
In 2009, Dr. Chou and colleagues reviewed 40 studies comparing epidural injections (and other types of injections or ablations) to placebo injections. For back pain without pain radiating down the leg (sciatic type pain), their conclusion was this: “Evidence on efficacy of epidural injections specifically for spinal stenosis, low back pain without radiculopathy, or failed back surgery syndrome is sparse and inconclusive, but showed no clear benefit.” For sciatic pain, a few of the studies showed some short term benefit, (within a few weeks) although the majority did not; and none showed longer-term benefit.
Dr. Staal (as part of the prestigious Cochrane Collaboration) also conducted a review of the available literature in 2008. He reviewed 18 different research trials that included 1179 participants. This was their conclusion: “There is insufficient evidence to support the use of injection therapy in subacute and chronic low-back pain.” These are hardly ringing endorsements for these procedures.
Have we learned more since then? In 2012, Cohen and colleagues reported on a randomized, controlled trial of epidural steroids for sciatic type pain due to ruptured discs. There was some benefit in the short term (at 4 weeks), but this result was not statistically significant and there was no benefit at all in comparison to the placebo injections at 3 and 6 months. Also in 2012, Pinto and colleagues once again reviewed the available literature on epidural steroid injections for sciatica. From 23 research trials they found that epidural injections showed very small benefit at 1 month (roughly a difference of one-half of a point decrease in pain on a 10 point scale) and no differences at longer-term follow-up.
When studies show that the intervention being tested is no better than the placebo intervention, we usually conclude that the intervention would not be recommended. If a medication works no better than a placebo pill, most doctors (and patients) would not use it.
Of course, doctors must also consider the potential side effects of an intervention. If the side effects are mild or rare, that treatment is more likely to be used even if it has only mild efficacy. Consider, for example, glucosamine and chondroitin sulfate, two herbal supplements often used for osteoarthritis. A recent study showed that they had mild effects on pain, but no effects on the progression of arthritis. While the positive effects are small, the risk of harm is low. There are few potential side effects of these products. Since their costs are reasonable, it may make sense to try them.
What are the potential side effects of epidural and other spinal injections?
The most significant risks include infections (leading to meningitis), paralysis or death. Fortunately, these catastrophic events are rare. In 2012, there was an outbreak of spinal meningitis after epidural steroid injections. Over 20 states were affected. Ultimately 751 serious infections were documented and 64 people died due to the infection. A more common risk is loss of bone density in the vertebrae of the spine due to the effects of the steroid medication, which can lead to spinal fractures especially in older individuals who have multiple injections.
Having reviewed the literature, let’s return to the recently published study from the July issue of the New England Journal of Medicine on injections for spinal stenosis.
Despite their results that these injections were not more effective than the placebo injection, the authors did not make any recommendations about the use of these injections. Nor did they mention the overall healthcare costs. Last year, the Journal of the American Medical Association published an editorial on the subject and the author noted that guidelines from the US, Europe, Italy and the United Kingdom all do not recommend injection therapy for low back pain.
Given that these data do not show clear evidence of efficacy over and beyond a placebo treatment and that several clinical guidelines don’t recommend these injections, how many injections do you think are performed each year? They’re probably decreasing, right?
Wrong.
Deyo and colleagues published an article entitled: “Overtreating chronic low back pain: Time to back off?” They documented that over a recent seven-year timeframe, the rates of injections for low back pain increased by 271%. Costs per injection also increased by 100%. This combination of increased injections plus increased cost per injection has led to a massive 629% increase in overall fees associated with these procedures. This was not due to an aging population either because the number of new enrollees in Medicare (i.e. aging people) only increased 12% during the same timeframe.
Currently, it is estimated that at least 12 million injections per year are done for back pain in the United States alone. Total costs of these injections are at least $500 million. A study by Abbott and colleagues noted that there is great variability in the number of injections given by certain doctors. Some doctors are more likely to give large numbers, from 10 to up to 50 per year to a single patient. The authors found that 10% of the doctors accounted for 36.6% of all of the injections and 20% accounted for over half. Thus, relatively few providers are performing a majority of all spinal procedures.
How can this be happening?
Here are a few possible reasons. First, patients often report improvement from injections. As we saw in the New England Journal of Medicine study, the level of pain dropped from about 7 to 4.5. When patients return and report that a procedure helped it can be difficult for doctors to believe their treatment is simply a high priced invasive placebo even if they review the research.
Some physicians may even ask what’s the harm in using these injections even if it is a placebo response? We know placebo effects can be incredibly powerful and this is especially true for pain (interestingly, more "invasive" placebo treatments are found to be have higher placebo responses).
However most ethicists would argue that administering a placebo treatment to patients without their knowledge is not ethical. Also, unlike many placebos, there are risks of significant complications associated with these procedures and there are obviously significant healthcare costs involved. Healthcare dollars are not an unlimited resource and every dollar spent on an expensive injection is a dollar that can't be used for other therapies.
A second reason may lie in the economics of injections. Physicians who regularly perform injection treatments for back pain can make a lot of money. An editorial comment on the Abbott study suggested that the doctors who are doing very large numbers of these procedures “may well be stretching the indications, accepting poor results, or be driven by profit.” Most doctors are not performing excessive amounts of injections. But if they took a careful and critical look at their practices, they might make some changes. And, as a society, we are making these decisions on a daily basis.
Let me tell you about a friend of mine, Dr. Kevin Cuccaro, who resides in Corvallis, Oregon. Dr. Cuccaro is an anesthesiologist who has completed a fellowship in pain management. He is very knowledgeable in the current management model of back and leg pain because he was involved in it for years.
For several years, Dr. Cuccaro worked as a pain specialist at the Naval Medical Center San Diego. There he treated active-duty service members with chronic pain—including many who had back and sciatic pain.
When physical therapy and exercise weren’t enough to help his patients, he relied (as do most pain management specialists) on pain medications and injections. Unfortunately, what he experienced was disheartening. Instead of getting better with injections many patients appeared to get worse. One injection led to another and then to another. It wasn’t clear that he was actually helping to reduce pain in his patients.
However, continuity of care was difficult in a military environment and Dr. Cuccaro reasoned that perhaps this was contributing to lack of patient improvement.
So, after he left the military, he joined an upscale private medical group in Oregon. Since he could now maintain continuity of care and deliver high quality pain management he expected his outcomes to improve.
It didn't turn out that way. The results he saw in his private practice were no better than those in the military. Basically, injections led to more injections and patients didn’t seem to improve overall.
Frustrated he went back to the medical research to find what he could be missing. What he found shocked him despite all of his training. Studies consistently demonstrated poor long-term outcomes with injections for chronic pain. A few papers reported brief improvement in pain but high quality studies did not find that these results were sustained for any significant length of time.
Even worse, the reasons used to support the use of injections for chronic back pain (like decreased medication use, increased activity or faster return to work) weren’t true at all. In fact the opposite was found. His patients were simply not getting better.
Most shocking of all, he learned that despite an astronomical rise in the number of injections (and surgeries) for back pain, outcomes in back pain in the U.S. appeared to be worsening—not improving.
However, injections were well reimbursed by Medicare and insurance companies and he was encouraged to continue using them. Instead, Dr. Cuccaro made a bold decision: he decided to leave his practice.
This is how he summarized his experience and why he decided to make a change:
“Once I questioned the use of injections, I went down a very scary rabbit hole. I realized much of what I was taught about treating pain simply wasn’t true. Yet despite this evidence, everyone kept telling me to do more injections. My group liked them because they were easy to schedule, didn’t take long and paid well. Referring doctors wanted me to do them because they thought injections would keep people off of opioids. Even patients were telling me to do more injections because they heard somewhere they needed a “series of 3” (a completely made up practice by the way).
However once I took a harsh look at ALL the research on chronic pain I had a difficult choice to make:
Do I believe I’m somehow better than every other doctor out there including those publishing the studies? Did I think that my injections, despite the lack of evidence, were helping people live happier healthier lives? If these injections aren’t helping much, do I turn a blind eye and pretend I’m not likely to harm anyone with these injections? Or do I leave my medical group and a traditional pain management practice?
These were the only options I had at the time and it would be nice to say leaving was an easy decision.
It wasn’t. I had (and still have) student loan debt, a mortgage, and a young family support. My practice was my livelihood. But it was the right decision to make.”
(You can see what Dr. Cuccaro is up to now by visiting his website, www.StraightShotHealth.Com)
Innovative research demonstrates those with chronic back pain have changes in how their brains process pain. These changes are similar to those found in other chronic pain syndromes like fibromyalgia. Additional research shows many of the structures often blamed for chronic back pain like “bulging” or “degenerative” discs aren’t abnormal at all. They’re also found in patients who don’t have back pain.
By always focusing treatment on structures located in the back, we are likely looking in the wrong place for many people who have chronic back pain.
So what then can be done for chronic back pain? Injections aren’t the answer and surgery should be viewed with caution. Pain medications, particularly narcotics, for chronic pain have their own set of problems.
There are better ways of treating most people (excluding those with fractures, tumors or infections) with chronic low back and sciatic type pain. These treatments require patients to be engaged and active in their recovery. They work because they help patients change their brain to stop the pain. They do not temporarily cover up the symptoms like injections or medications do. For those willing to challenge themselves and take control of their own healing process there is hope.
I have conducted an outcome study of patients with chronic back and leg pain (these data have been presented at 3 conferences, the full study will be published soon). All of them completed the 4-week mind body program I run in Michigan. The results, at a six-month follow up evaluation, showed that over 50% of patients had a greater than 50% reduction in pain. Almost two-thirds had at least a 30% improvement in pain. These reductions in pain are highly significant and occurred in individuals who had an average duration of back pain of over 8 years. The average pain score was over 5 on a 10-point scale prior to the program and averaged 2.8 at the six-month follow up. Although some continued to have significant pain, many were pain-free.
The patients I see have been willing to look at how stress has affected them and how it has caused both emotional and physical pain. They made a commitment to heal. They stopped fearing pain and took control over it. They often made important changes in their lives. This can be hard work, but their stories show that recovery is possible.
Dealing with chronic back (and other) pain can be overwhelming and I see the ravages of chronic pain on my patients and their families every day. When one is in severe pain, it’s difficult to resist the advice of doctors to have invasive procedures. As the research shows, spinal injections do reduce pain for many people and most doctors are well meaning and honorable. However, the studies also show this: If you’re told you need an injection for your back pain you might be getting an expensive, and potentially risky, placebo.
To your health,
Howard Schubiner, MD
