Advances & Insights: Neurosciences
March 31, 2008
What the news means for you
Phillip A. Tibbs, MD
Evidence-based medical practice is validated
An important aspect of this article is that it constitutes evidence-based medicine. With the cost of health care so high, and concern about how high it can go, the government and insurance companies are challenging doctors to prove that the treatments they’re recommending are effective.
“The best surgeons are very cautious and don’t rush into surgery.”
I believe it’s the duty of medicine as a group to take this concern seriously, to respond to it, to try to be as scientific as possible and to conduct these clinical trials. Here at the University of Kentucky, our neuroscience group has had a committed interest in evidence-based medicine for more than 20 years.
In areas such as spinal stenosis, the results of these clinical trials are so significant that surgery will be recognized as the standard of care. Another phase of the SPORT study compared surgical and nonsurgical treatment of ruptured discs. In that case, patients who waited long enough did almost as well without surgery. However, there was a group of people who were in a great deal of pain while they were waiting and wanted to go ahead and have the surgery. This is all information that well-informed consumers need to have so they can understand their options when they talk with their doctor.
Only about 10 to 15 percent of patients who undergo a spinal laminectomy require further surgery. However, once you have a degenerative spinal condition, it’s something you live with for the rest of your life. Patients who have surgery this year and experience excellent relief may later develop spinal stenosis in another area of the spine and need a second operation. Also, some patients may develop a slippage and need a spinal fusion. The treatment that is perfect for someone this year may not prevent a condition from arising at other levels of the spine several years in the future.
“Although more than 95 percent of the patients have no complications from a spinal laminectomy, there are risks involved.”
Conservative therapy first
If you look at large groups of patients who’ve had spinal surgery, you’ll find many who’ve had success and some who haven’t. What are the causes for failure?
Sometimes the patient may not have needed surgery in the first place. The back pain could have been due to some other condition. There could also be technical factors that prevented the doctor from safely and completely achieving the goal of decompression. And there are other patients who may simply require more surgery.
No patient should have back surgery without receiving conservative therapy first. We never perform surgery for spinal stenosis or a herniated disc without first giving nature time to take care of the condition or using medications, physical therapy or injections.
In my view, the best surgeons are very cautious and don’t rush into surgery. When they recommend a procedure, they have every reason to expect it will benefit their patient. At the University of Kentucky, we often see patients who come to us for a second opinion because they felt rushed by their first doctor. The truth is, most of the time the first doctor was correct, but the patient wasn’t ready yet for the surgery. Patients often seek us out at UK because they know we have a reputation for being conservative about surgery.
Although more than 95 percent of the patients have no complications from a spinal laminectomy, there are risks involved. First, we may not be able to give complete relief. Some patients may have considerable nerve damage that cannot be undone by the time they see the surgeon. You have to balance the need to not to rush into surgery with not letting the patient wait too long and suffer nerve damage.
Other complications include a blood clot, infections, spinal fluid leakage, nerve damage due to surgery, difficulty with bowel or bladder function, disc slippage, or complications from anesthesia. No patient would be allowed to undergo surgery without preoperative evaluation.
In most cases, persistent pain will motivate the patient to accept the small risks of complications with surgery. The main advantage the SPORT study showed for spinal surgery (in the ‘as-treated’ analysis) was significantly greater improvement in pain reduction, function, satisfaction and self-rated progress than patients receiving nonsurgical treatment. The most common pain that can be relieved surgically is nerve pain that radiates along the leg. We rarely operate for low back pain not associated with leg pain.
Trends in spinal surgery
Spinal surgery is an exciting area of neurosurgery and orthopaedic surgery right now. One trend is toward minimally invasive surgery. We’ve been able to miniaturize incisions in many cases so that patients can have major surgery as an outpatient or with only an overnight stay in the hospital.
Any type of spinal surgery is a commitment and an investment of the patient’s time and money. But when properly done, the success rate is very high.
Dr. Tibbs is director of the UK Spine Center and chair of neurosurgery in the UK College of Medicine.
Surgery often the best approach for spinal stenosis, study finds
In a recent report of the largest study to date on treatment for spinal stenosis, researchers conclude that patient outcomes are better after back surgery than after nonsurgical treatments. This report is the third in a series detailing the results of the Spine Patient Outcomes Research Trial, or SPORT, a seven-year, $21-million study funded by the National Institutes of Health and the Centers for Disease Control and Prevention.
This phase of the study was conducted over a two-year period at 13 medical centers throughout the United States. Results were published in the Feb. 21 issue of the New England Journal of Medicine .
Spinal stenosis, a painful narrowing of the spinal canal that is most often associated with age-related deterioration, is the most common reason for spinal surgery. However, the effectiveness of spinal surgery as gauged against other therapies has never been proved in randomized trials - until now.
James N. Weinstein, DO, of Dartmouth Medical School, and his colleagues followed 654 patients diagnosed with spinal stenosis. Of that number, 289 were randomly assigned to receive surgery or nonsurgical care such as physical therapy, education, home exercise instruction or nonsteroidal anti-inflammatory drugs. Out of the 289, 138 were assigned to surgical treatment and 151 to nonsurgical treatment. The remaining 365 patients declined random assignment to a treatment group and selected their own treatment method: 219 chose surgery and 146 chose nonsurgical treatment.
As it turned out, nonadherence to the selected or randomly assigned treatment method in all groups brought the number of patients who underwent surgery at some point during the two-year study period to 400, while 254 patients received nonsurgical treatment.
The patients, whose mean age was 65 years, had severe lumbar spinal stenosis without spondylolisthesis - a condition in which a vertebra in the lower part of the spine slips - and had experienced at least 12 weeks of leg symptoms. The spinal conditions were confirmed by imaging studies.
Treatments and outcomes
The most common surgical procedure performed for lumbar spinal stenosis is decompressive laminectomy, in which the laminae (roofs) of the vertebrae are removed to create more space for the nerves and to relieve pressure. Most of the patients who had surgery in the SPORT study underwent this procedure. Nonsurgical treatment outcomes were determined by the patients’ levels of pain and physical function, as measured by their responses to standardized questionnaires.
“For the patients who underwent surgery, positive results were evident as early as six weeks after the procedure.”
An intention-to-treat analysis found a significant effect favoring surgery for pain but not for physical function. An as-treated analysis including both cohorts, however, showed significant differences between the surgical and the nonsurgical group in both outcome measures. For the patients who underwent surgery, positive results were evident as early as six weeks after the procedure. These effects reached their peak at six months and continued for two years. The patients in the nonsurgical group showed only moderate improvement over two years.
The most common complication associated with the surgical procedure was a dural tear experienced by 9 percent of the patients. After two years, 8 percent of the patients had undergone another operation, but fewer than half of these additional procedures were performed because of recurrent spinal stenosis. With or without surgery, none of the patients worsened.
Deciding to have surgery
The American College of Neurosurgeons cautions that not every patient will benefit from spinal surgery. Doctors may recommend surgery if conservative treatment options, such as physical therapy and medications, do not reduce the pain or relieve it altogether.
A patient in reasonably good health may be considered a candidate for spinal surgery if he or she experiences the following symptoms:
- Back and leg pain that limits normal activity or impairs quality of life.
- Progressive neurological deficits, such as weakness and/or numbness of a leg.
- Loss of normal bowel and bladder functions.
- Difficulty standing or walking.
- No relief with medication and physical therapy.
UK HealthCare Services - Kentucky Neuroscience Institute
For more information, or to make an appointment with a UK HealthCare physician, please call UK Health Connection at 1-800-333-8874.