Study Shows Surgery Is More Effective Than Other
Treatments for Common Back Problem
When it comes to low back pain, physicians generally advise exhausting
nonsurgical options before resorting to surgery. But a new study
shows that for degenerative spondylolisthesis with spinal stenosis,
surgery provides significantly better results than nonsurgical
alternatives. The study, published in the May 31 issue of the New
England Journal of Medicine, is the second in a series reporting
findings of the Spine Patients Outcomes Research Trial (SPORT),
a five-year, multicenter study supported by the National Institute
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part
of the National Institutes of Health.
Degenerative spondylolisthesis is a condition in which breakdown
of the cartilage between the vertebrae of the spine causes one
vertebra to slip over the one below. This can result in narrowing
of the spinal column (spinal stenosis), which can put pressure
on the nerves, resulting in pain in the buttocks or legs with walking
or standing. The condition generally occurs after age 50 and it
affects six times as many women as men.
The management of degenerative spondylolisthesis with spinal stenosis
is controversial, says James N. Weinstein, D.O., M.Sc., lead author
and chairman of the Departments of Orthopaedics at Dartmouth-Hitchcock
Medical Center and Dartmouth Medical School. Surgery is widely
used, but its effectiveness in comparison with nonsurgical treatment
had not been demonstrated in controlled clinical trials. The purpose
of this arm of the SPORT trial was to make that comparison.
SPORT followed 601 patients diagnosed with degenerative spondylolisthesis
and symptomatic spinal stenosis. Of those, 372 received a surgery
called decompressive laminectomy, which involved removing bone
and soft tissue to relieve pressure on the nerves. The remaining
235 pursued nonoperative treatments such as physical therapy, steroid
injections and analgesic medications. Two years after enrollment
in the trial, patients in the nonoperative groups reported modest
improvement in their condition; however, patients who had the surgery
reported significantly reduced pain and improved function. Furthermore,
for the surgery group, relief from symptoms came quickly; some
reported significant improvement as early as six weeks after the
procedure.
“The SPORT study was undertaken with one purpose in mind: to give
physicians and patients solid information that would allow them
to make informed choices when faced with a decision of how to treat
their back condition,” says Dr. Weinstein. “As a surgeon, it’s
very important to me that I have evidence that I can share with
my patients as they are trying to decide how to proceed with treatment.
Up until now, we suspected surgery produced better results, but
we had little objective data to support that. With the results
of this study, we can now discuss much more fully the surgical
and nonsurgical options available to our patients so that they
can make an informed choice.”
The study initially intended to randomize patients into either
a surgical or nonsurgical group and then observe and compare the
results of the two groups. Unfortunately, a comparison of the two
groups wasn’t as easy as hoped. The researchers found that 40 percent
of patients crossed over from the group into which they were randomized.
That is, members of the nonoperative group chose to have surgery
and members of the surgical group decided to forgo surgery for
nonsurgical treatments. For that reason, the researchers compared
groups based on the treatment they actually received instead of
the treatment group to which they were assigned. Because the scientists
were also studying similar patients who wanted to select which
treatment they would receive (instead of being randomly assigned
to a surgical or nonsurgical option), they were able to pool results
from both studies, essentially creating a more powerful osbservational
study at the expense of information gained from the statistically
rigorous study design originally planned.
Patient crossover was also an issue in the first arm of the SPORT
trial, which showed that patients who underwent surgery for another
common back problem — herniated discs — experienced
slightly more improvement than those who opted for nonsurgical
treatments. Results of that trial were published in the Journal
of the American Medical Association last November.
Results from the third major SPORT study, on the effectiveness
of surgery vs. nonsurgical options for spinal stenosis without
spondylolisthesis, are expected to be released later this year.
NIAMS Director Stephen I. Katz, M.D., Ph.D., applauds the SPORT
trial, saying its findings are beneficial for people with these
common back problems. “While it is generally not a good idea to
rush into back surgery, the SPORT trial shows there are conditions
for which surgery clearly is the most effective treatment choice.
These findings will help doctors better counsel their patients
about treatment options.”
Additional support was provided for this research by the NIH Office
of Research on Women’s Health and the National Institute of Occupational
Safety and Health (NIOSH).
The mission of the National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS), a part of the Department of Health and
Human Services’ National Institutes of Health, is to support research
into the causes, treatment and prevention of arthritis and musculoskeletal
and skin diseases; the training of basic and clinical scientists
to carry out this research; and the dissemination of information
on research progress in these diseases. For more information about
NIAMS, call the information clearinghouse at (301) 495-4484 or
(877) 22-NIAMS (free call) or visit the NIAMS Web site at http://www.niams.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and Centers
and is a component of the U.S. Department of Health and Human Services.
It is the primary federal agency for conducting and supporting basic,
clinical and translational medical research, and it investigates
the causes, treatments, and cures for both common and rare diseases.
For more information about NIH and its programs, visit www.nih.gov.
Reference: Weinstein JN, et al. Surgical
versus nonsurgical treatment for lumbar degenerative spondylolisthesis. NEJM 2007;356(22):2257-2270.
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