Spinal Cord Stimulation or Repeat Spine
Surgery: Emory Studies Which is Most Effective for Treatment of Chronic
Low Back Pain
Could a small device implanted under the skin be the answer
for thousands of patients suffering with persistent leg and back pain
following low back surgery? Doctors at Emory University are trying to
determine if spinal cord stimulation, rather than more surgery, can
be an effective treatment for patients with a condition called Failed
Back Surgery Syndrome (FBSS). The new study, recently underway at the
Emory Spine Center, is the first of its kind to compare two treatments
for chronic low back pain and leg pain: spinal cord stimulation and
repeat spine surgery.
"Spinal cord stimulation works by blocking pain signals from reaching
the brain," says Howard Levy, M.D., assistant professor of orthopaedics,
Emory University School of Medicine and principal investigator of the
two-year trial at Emory. "The device is implanted in the lower
back and wires, or leads, connected to the device are run into the spinal
canal. Once the device is in place, patients can turn it on and off
with the touch of a magnet."
Approximately 200,000 Americans annually undergo an initial spine surgery
for the treatment of low back and leg pain, according to a 1998 survey
of spine surgeons. The same research indicates that about 25 percent
of these patients continue to experience unresolved pain after surgery.
And, despite a second procedure to relieve the pain, more than 13,000
patients still suffer from unresolved pain.
Participants will be randomized in this trial, meaning some will be
implanted with the spinal cord stimulator and some will undergo a second
spinal surgery. "In the end, the study is expected to tell us which
treatment option provides reduced pain, greater functional status, improved
quality of life and reduced disability to patients with chronic low
back and leg pain," according to Dr. Levy.
Participants in the study must meet the following criteria: previous
back surgery more than a year prior to enrollment, failure of alternative
treatment measures such as medical or physical therapies, disabling
pain that has limited their social and vocational activities, and ages
20 or older.
As with any treatment, side effects can occur. Because spinal cord
stimulation systems are surgically placed, infections are possible.
Potential complications from spinal cord stimulation may include undesirable
changes in stimulation, lead migration and loss of pain-relieving effects
in some patients. Since spine surgery involves the nervous system, nerve
damage is another risk. Both spinal cord stimulation and reoperation
are standard medical procedures used to treat chronic pain.
Emory is one of 11 sites participating in this study, funded by the
National Spine Network (NSN), based in Marietta, Georgia. To learn more
about this study, call the Emory Spine Center at (404) 778-7000.