"It's open season on the American spine."
Does Anyone 'Need' Spine Surgery?
Elective Surgery for Back Pain: Facts and Myths
Evidence is the password to all that is scientific in medicine.
For better or worse -- and largely for better -- we have all come to rely on the evidence when we make medical choices, and presume that our physicians are relying on evidence when we are offered options.
Evidence that we are not fooling ourselves or being fooled has been a grail of philosophers for centuries.
But today the focus is on drugs, particularly new drugs.
Most of medicine escaped this new level of oversight and still does. In particular, procedures fall out of the purview of the FDA unless the procedure involves placing some substance or widget into the body, and then the test relates more to safety than evidence of efficacy.
Is Surgery Always Best?
Most surgery is not "evidence-based;" it remains eminence-based, dripping with hubris.
For necessary surgery, there may be no better way than to turn than to experienced surgeons who hold survival in their hands. To their credit, surgeons are willing to make head-to-head comparisons of different approaches.
Of course, it would be unconscionable not to do what is considered, at least by some, to be the best in any desperate situation. Spine surgeons can be heroes in this regard, when it comes to stabilizing fractured or tumor-riddled spines.
But most surgery today is "elective." It is not necessary, because it is not certain that you will be better off for it, or worse off without it.
Slowly but surely, elective surgery is being subjected to studies designed to generate evidence necessary to make an informed decision. But with very rare exception, all these studies are seriously flawed by avoiding the most stringent test of efficacy.
These studies compare one procedure with another, or one procedure with a nonsurgical therapy. But the only true test of elective surgery is to compare the surgery that is believed to work with a sham procedure.
You heard me right. When this has been done for angina and for knee pain, the sham procedure is at least as good as the one thought to have worked.
I have no problem with a study that informs the volunteers that they are likely to have a sham procedure. In fact, I'm troubled that such is not commonplace.
The Back Surgery Debacle
Nearly all surgery for regional back disorders is elective. I coined the term regional back disorders for an editorial in the New England Journal of Medicine 20 years ago. It denotes the back pain and other symptoms that afflict adults who are otherwise well, who have suffered no overt trauma, and who have no major neurological complication.
Depending on where you live in the country, you can run a 10-fold greater risk of being offered and accepting surgery for a regional back disorder than if you live in any other country. It's open season on the American spine.
Nearly all this surgery is for low back pain. Spine surgeons have long felt beleaguered by critics such as me. After all, there have been a number of studies, mainly from Europe, that fail to generate an iota of evidence for any benefit from any form of spine surgery for regional low back pain. For workers' compensation claimants, surgery is likely to leave you worse off.
If you are offered any form of surgery for regional low back pain, please ask for the evidence. Before you agree to the surgery, ask whether you are likely to do as well without it. To my way of thinking, if elective surgery for regional back pain were a pharmaceutical it wouldn't be licensed.
Few spine surgeons appreciate me for my way of thinking. I have some empathy. Years of technical training and the development of a special surgical perspective are trumped by the evidence. No wonder the two papers in a recent New England Journal of Medicine were met by fanfare in the press, and celebration in the spine surgery community.
Neither paper has anything to do with regional low back pain -- my forewarning still pertains. Each tackles a special regional low back disorder that need not cause low back pain, but is characterized by pain into the buttocks or legs.
One paper is an analysis of a subset of patients in a very large American randomized trial comparing surgery with medical treatment for various regional back disorders. This brilliantly designed trial was bedeviled by our cherished patient autonomy; many of the volunteers refused to stay with the treatment to which they were randomized. There was so much crossover that I'm sure the statisticians suffered indigestion. They massaged the data nonetheless and still could find no joy from surgery for regional low back pain.
Then they came up with this subset. It took four years for the doctors in 13 centers in 11 states to find 600 patients who had persistent pain into the buttocks or a leg when they walked and had very impressive degenerative changes in their spinal anatomy -- a combination that is considered a special disorder, "spinal stenosis."
The surgical remedy is somewhat drastic, particularly for a population that tends to be elderly and even frail. It usually involves fusing the spine and is associated with greater than 10 percent incidence of important complications.
The analysis suggests benefit of the surgery. I will accept that result only because of a similar trial from Finland with far less crossover. In the Finnish trial, patients improved regardless of the treatment. Those with the surgery reported a bit less discomfort but no more mobility.
If I develop spinal stenosis, I wouldn't let you operate on me for that piddling outcome. I'd swallow my pride and walk bent over a walker (which usually alleviates these symptoms) before I'd risk surgery.
The other paper is one of many looking at patients with sciatica: pain down the leg with or without back pain.
Most get better too quickly to justify surgery, even in America. For those who are hurting for a couple of months, surgery has something to offer. They are more likely to be better once they recover from the surgery than patients treated medically, though the medically treated patients catch up by year's end.
That's not much to write home about. I'd need to see a sham control before I'd believe the "surgery for subacute sciatica" mantra.
Based on the evidence, the currently available surgical remedies for regional spine disorders belong next to tonsillectomy in the archives.
Dr. Nortin Hadler is professor of medicine and microbiology/immunology at the University of North Carolina at Chapel Hill, and an attending rheumatologist at University of North Carolina Hospitals. He is the author of The Last Well Person.
A large study by Dvorak J. et al. reviewed the long-term results of patients that had received surgery for lumbar disc herniations . They reported that of the 575 patient’s studied, 70% still complained of back pain; 83% complained of constant heavy pain; 45% have a residual sciatica; 35% are still under some kind of treatment; 47% are receiving a disability pension and 17% required repeat surgeries.
The authors stated “Based upon the criteria given by Spine as related to justified or unjustified indication, there was no statistical difference in long-term results for surgery as compared to conservative care”. “The so-called justified indication for disc herniation neurosurgery does not necessarily imply a good long term result.”
The overuse of surgery has been perhaps the single most damaging medical intervention for back pain sufferers. Bigos and Battie reported, “Surgery seems helpful for at most 2% of patients with back problems, and its inappropriate use can have a great impact on increasing the chance of chronic back pain disability.
In a Volvo award winning paper, Waddell reports, “Dramatic surgical success unfortunately only applies to approximately 1% of patients with low back disorders. Our failure involves the remaining 99% . . . for whom the problem has become progressively worse.”
Saal and Saal supervised care for a group of patients referred by neurologists for surgery. They attempted rehabilitation for these patients and made the following observations: “Surgery should be reserved for those patients for whom function cannot be satisfactorily improved by a physical rehabilitation program . Failure of passive non-operative treatment is not sufficient for the decision to operate.” They also reported that, “the premise that operative patients fare better in the first year is contrary to our results, and the notion that surgery is necessary in a patient with a large disk extrusion is not supported in the literature. The presence of a disk extrusion does not adversely effect the outcome of non-operative treatment and should not be used as overwhelming evidence that surgery is necessary”.
In 1983, Weber reported that, even in properly selected patients, there is no difference in outcome between surgically and conservatively treated patients at two years.
In 1992, Bush et al stated that, “86% of patients with clinical sciatica and radiologic evidence of nerve root entrapment were treated successfully by aggressive conservative management.” They reported that, “the intervertebral disc pathomorphology that might seem best suited to surgical resection is in fact that which shows the most significant incidence of natural regression. . .these results confirm that if the pain can be controlled, nature can be allowed to run its course with the partial or complete resolution of the mechanical factor . . .lumbar herniated nucleus pulposus can be treated non-operatively with a high degree of success.”
Bush et al also stated that ‘Surgery clearly has its place in the treatment of lumbar spine disorders. Conservative care practitioners must be able to select the patients who satisfy the criteria for surgical intervention. These criteria are more strict than previously believed.
EPIDURALS: HOW EFFECTIVE?
Epidural Steroid Injections: Epidural corticosteroid injections have been used have been used for nearly half a century and are widely used in everyday clinical practice. They may be helpful for reducing tissue inflammation and short-term pain relief in a patient with an acute radicular low back problem who is unable to participate in an active treatment program because of severe leg pain and/or neuromotor deficit.
In randomized, double blind trials, patients were given up to three epidural injections of corticosteroids versus saline . After three months, there were no significant differences between the groups. The authors concluded that “although epidural injections may afford short-term improvement in leg pain, this treatment offers no significant functional benefit, nor does it reduce the need for surgery.”
A recent randomized double-blind trial published in the Annals of Rheumatic diseases (2003) concluded that steroid injections for sciatica are no better than saline. These findings are consistent with those of another definitive trial presented at the recent American College of Rheumatology meeting.
Lumbar Support Belts: According to a large new prospective cohort study conducted by researchers at the National Institute of Occupational Safety and Health, lumbar support belts do not prevent back pain or back pain disability. In the largest prospective study of back belt use, adjusted for multiple individual risk factors, neither frequent belt use nor a store policy that required belt use was associated with reduced incidence of back injury claims or low back pain. The study found no beneficial effect of belt use in any group: among employees with and without a history of back injury, employees with consistent belt-wearing habits, or employees with the most strenuous jobs.
Results based on multiple studies all converge to a common conclusion: back belt use is not associated with reduced incidence of back injury claims or low back pain in material handlers.
For back pain sufferers, surgery isn't always the answer
Back pain sufferers can wind up desperate for relief. But just because a treatment is new, expensive or elaborate doesn't mean it will actually make you feel better.
An aching back -- a dull twinge or a stabbing pain, lasting days or years -- is a source of annoyance, misery or even disability for millions of sufferers.
Eighty percent of the population will experience back pain at some point in their lives, and while the majority of cases resolve quickly, 30% recur, according to the North American Spine Society, an association of spinal health professionals based in Burr Ridge, Ill.
Those aching backs, in turn, cost Americans more than $80 billion in healthcare costs, time off from work and other expenses, the spine society says. There is evidence that the suffering is rising slightly -- perhaps because people spend more time hunched over computer keyboards. A 2008 study, published in the Journal of the American Medical Assn., found that the percentage of U.S. adults seeking medical help for spine problems rose from 12% in 2000 to 15% in 2005.
Rising significantly, meanwhile, are expensive treatments and surgeries that may not help patients much. The same study found that patients are spending more money on back pain treatment -- an average of $6,096 per patient in 2005, up from $4,695 in 1997 -- without seeing corresponding improvements in how they feel.
The research implies that expensive treatments with glossy advertising may not be as good as they sound, says study author Brook Martin, a health services researcher at the University of Washington in Seattle.
Surgery rates, in particular, are going up. More professionals now argue that doctors need to think more before they resort to the knife. They note that the U.S. has, by far, the highest frequency of back surgeries among developed nations: There are approximately 1.2 million spinal surgeries in the U.S. each year, double the rate in those other countries. Yet there is no evidence that Americans have a higher rate of back pain or injury.
"I don't think you want to take the surgical option lightly," says Dr. Gunnar Andersson, an orthopedic surgeon at the Rush University Medical Center in Chicago.
For the lucky ones who benefit from surgery, it's certainly worth the risk and costs, he says. Others may not get the results they anticipate.
Spine sets squeezed
The spine is a stack of bony vertebrae separated by gel-filled discs that act as shock absorbers. "It's one of the major ways the human body fails," says Dr. Aaron Filler, a spinal surgeon in Santa Monica. In part, back pain is the price mankind pays to stand upright. When the spine is horizontal, as it is in a four-legged animal, additional weight causes the vertebrae to spread out. But in people, more weight pushes the vertebrae and discs together -- and there is only so far the structure can compress.
Over time the effects of aging, use and gravity wear on the spine, making the 40-plus crowd most susceptible to back pain, though injury or stress can occur at any age.
Back pain is a symptom with many possible causes. Sprains, muscle tears and spasms are common. The discs, which cushion the vertebrae, can also suffer injury. In a herniated disc, the gel inside leaks out and irritates nearby nerves. Or the disc's outer layer merely thins, allowing the gel inside to form a bulge, which may also poke a nerve.
The joints between vertebrae, called facet joints, are susceptible to wear and tear, particularly in people with arthritis. The joint's cushioning cartilage can wear thin and the bone can jut out, causing pain in the back and thighs.
And as discs or bone protrude past their normal locations, the interior of the spine can narrow, putting pressure on nerves in a condition called stenosis.
Older people are more susceptible to back pain as are pregnant women, who carry added weight on the spine. Children, however, are not likely to suffer back pain without an obvious injury as the cause. "If I see a teenager with back pain, it really raises red flags," says chiropractor Robert Hayden of Griffin, Ga.
Hayden believes part of the rise in back pain patients has to do with the personal computer. Leaning over to type or peer at the screen strains the extensor muscles in the neck and the trapezius and rhomboid muscles that hold up the shoulders. The extensors, in particular, are small, thin muscles, and with too much use they can run out of oxygen, causing irritation or spasms.
The postural muscles in the lower spine, such as the quadratus lumborum, can also get sore if a person leans forward or slumps for a long time.
Being inactive can contribute to back problems because the body's core muscles -- the back and abdominal muscles that hold up the torso -- weaken and become more susceptible to tears or pulls. Weak muscles can also cause problems by forcing the spine to support extra weight -- as does obesity.
The good news is that most back pain goes away on its own. For minor complaints such as muscle strains, most doctors recommend over-the-counter painkillers, heat to relax the muscles, or ice to reduce swelling and numb pain.
In addition, it's best to keep up with daily activities as much as possible. "Doctors used to recommend bed rest for back pain . . . It turns out people get worse with bed rest," surgeon Filler says. Allowing the muscles to weaken can slow recovery -- whereas stretching and physical therapy can hasten it. A 2005 review found that patients who remained active, compared to those on bed rest, had a bit less pain and recovered a little more function.
Sign of trouble
A primary-care physician can evaluate back pain and make sure it doesn't signal something serious, such as an aneurysm, an ulcer, cancer or an infection. Numbness, pain that shoots down the legs (sciatica) or trouble controlling the bowel or bladder may indicate nerve damage and require medical attention. If the pain is the result of an injury or fall, one should also see a doctor to make sure nothing is broken.
When pain lasts more than three months, doctors classify it as chronic back pain. They will use a detailed history, physical exam and, sometimes, X-rays or other imaging tools to decipher what's wrong.
There are several possible treatments for back pain, but more patients find themselves on the operating table.
Surgery rates rose sharply between 1992 and 2003, from three in 10,000 Medicare patients getting back surgery in 1992 to 11 in 10,000 in 2003, according to a 2006 study in the medical journal Spine.
If a disc is damaged, a surgeon can remove the leaking or bulging material, or take out the disc entirely. For a fracture, two vertebrae can be fused with bone grafts or metal hardware to stabilize the spine.
To treat people with stenosis, surgeons can remove some of the spine to relieve pressure on nerves. Doctors can also use a laser or radio signal to burn away pain nerves or the material inside a bulging disc, a less invasive form of surgery.
Sometimes back surgery brings relief. A study funded by the National Institutes of Health, published in 2006, 2007 and 2008 found that surgical patients recovered more quickly and fully than nonsurgical patients with herniated discs, stenosis and slipped vertebrae.
The study, done at 13 medical centers across the country, enrolled more than 1,700 patients who were surgical candidates for one of the three conditions. Some patients went under the knife; others had nonsurgical treatments such as medication, physical therapy or restricted activity.
Statistical analysis showed faster recovery in the surgical patients, though many nonsurgical patients experienced good recovery as well. All patients in the study were also experiencing sciatica, so the findings may not apply to people whose pain is only in the back.
Despite these results, there is a long-standing controversy among spinal specialists over how often surgery is the best option -- and some say surgeons can be too quick to sharpen their scalpels.
Part of the reason for the U.S.' high rates is probably cultural. "We're in a little bit of a quick-fix society," says Dr. Steven Richeimer, chief of the division of pain medicine at USC. Doctors may also be seduced by flashy new drugs or devices because they genuinely want to help their patients, says Dr. Richard Deyo, an internist at the Oregon Health and Science University in Portland.
But many surgeries fail to heal the pain. Doctors even have a name for the problem -- failed back surgery syndrome.
The exact success rate for surgical intervention is difficult to calculate, but Deyo notes that approximately 20% of surgical patients will have another surgery within a decade, indicating that the first operation was unsuccessful.
Part of the problem is that the exact cause of the pain isn't always known. For most back pain patients, Deyo says, doctors cannot discern a specific cause. And advanced imaging techniques -- though popular -- may be misleading.
"When you do magnetic resonance imaging or computerized tomography scans of the spine, you sometimes see horrible things in normal people," Deyo says. One-fourth of people under 60 have a herniated disc, he says, and half have a bulging or degenerated disc. "And yet these are people who have no back pain."
Those deformed discs may look like trouble to surgeons, though, so they may remove a disc that wasn't even causing pain -- leaving the real problem unaddressed.
The vast majority of injured discs will heal without surgery, Hayden says. In addition, surgery carries its own small risk for complications, such as nerve damage or a tear in the tissue around the spinal cord, which could mean lasting numbness or further surgery.
Surgery also carries a high price tag. Spinal fusion, for example, runs about $60,000. Medicare pays out nearly $1 billion for spinal surgery each year. Many physicians and surgeons are concerned that some of their colleagues may push expensive procedures because they have a stake in companies that produce the necessary equipment or devices. Dr. James Weinstein, a spinal surgeon at Dartmouth Medical School in Hanover, N.H., cites as an example the metal cages for spinal fusion that came onto the market in 1996 and were touted to doctors in an aggressive ad campaign. Surgery rates soared.
"It certainly is good for Wall Street and the companies that are selling the equipment, and good for many of the highly paid consultants," says Charles Rosen, director of the Spine Center at UC Irvine. "But it's not the best for patients."
Concerned with the rise in surgery rates, in 2006, Rosen founded the Assn. of Ethical Spine Surgeons (now the Assn. for Medical Ethics), which includes more than 200 spinal surgeons. The association calls for doctors who receive more than $50,000 in consulting fees to make their company connections known and consider recusing themselves from leadership positions such as editorship of scientific journals.
Doctors say the high-surgery trend is unlikely to change soon, but that education of doctors and patients is key. Deyo, among others, is developing patient decision-making guides, and studies have shown that patients who have more information are less likely to opt for an operation.
So how can doctors and patients define a good candidate for surgery? Andersson suggests patients should wait six months, trying other therapies, before opting for an operation. Deyo says a surgery candidate should have imaging studies that match the symptoms, and leg pain indicating nerve involvement. Filler says that one useful test is that if a localized anesthetic directed at the suspected problem does indeed numb the pain, it probably is the correct target for surgery.
There are plenty of treatment options to try before considering surgery. It is sometimes difficult to evaluate the effectiveness of therapies because most back pain fades regardless of treatment. And some newer treatments haven't had much evaluation.
The main thing, experts say, is to be informed. "There's been a big increase in the intensity of treatment for back pain," Deyo says. That intensity, he says, would better serve many if it focused more on finding the best therapy for each patient -- and less on the surgical quick fix.