Could a small device implanted under the skin be the answer for thousands
of patients suffering from persistent leg and back pain following lower-back
Doctors at Emory are trying to determine if spinal cord stimulationrather
than more surgerycan be an effective treatment for patients with
a condition called Failed Back Surgery Syndrome. The new study, recently
under way at the Emory Spine Center, is the first of its kind to compare
two treatments for chronic low-back and leg pain: spinal cord stimulation
and repeat spine surgery.
Spinal cord stimulation works by blocking pain signals from reaching
the brain, said Howard Levy, assistant professor of orthopaedics
and principal investigator of the two-year trial. 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 in the trial will be randomized; some will be implanted with
the spinal cord stimulator, while 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 lower back and leg
pain, Levy said.
Participants in the study must be 20 years or older and 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), and disabling pain that has limited their social and vocational
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, based in Marietta. To learn more about this study, call
the Emory Spine Center at 404-778-7000.