health & wellness »
Back Breakthrough
Beaumont doctor helped design study for
minimally-invasive back pain treatment.
I
It
on the
the
It may
may be
be beautiful on
outside
what's on
on the
the
outside but
but it's
its what’s
inside
counts
inside
that that
really
counts.
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64 August 25 • 2016
t’s the most common reason peo-
ple go to their doctors — back
pain. According to the National
Institutes of Health, 80 percent of
adults will experience low back pain
some time in their lives. In fact,
chronic low back pain, lasting 12
weeks or longer, affects nearly one-
third of the nation’s population.
Laura Donlon, 48, of Monroe had
been dealing with low back pain
for five years before she found out
about a back pain study at Beaumont
Hospital in Royal Oak.
The flight attendant says her pain
was unbearable at times, especially
when sitting. Seeking relief from
her pain, caused by a degenerative
disc, she contacted the orthopedic
research team at Beaumont for
details.
Treatments for low back pain
range from noninvasive to invasive:
physical therapy, pain medications
to major surgery, such as spinal
fusion. Now a mini-
mally invasive nerve
ablating procedure,
recently cleared by
the Food and Drug
Administration,
may give some
people with chronic
low back pain a new
treatment option.
Dr. Jeff
“In 25 years of
Fischgrund
practicing orthope-
dics, this is the most important clini-
cal study I’ve ever done,” said Jeffrey
Fischgrund, chairman, Orthopedics,
Beaumont Hospital, Royal Oak, and
principal investigator of the FDA-
approved Relievant SMART trial.
“The system is proven to be safe and
effective in clinical trials. It is much
less invasive than typical surgical
procedures to treat low back pain.”
A spine expert and orthopedic
surgeon, Fischgrund helped design
the research study. Research teams
in the United States and Germany
recruited 225 participants, with 150
receiving the minimally invasive,
ablation treatment and 75 receiving
the placebo.
Donlon was told she met the trial
criteria and enrolled in the study. In
December 2014, she had an outpa-
tient spine procedure by Beaumont
physicians. Because she did not
know if she received the minimally
invasive trial procedure or a placebo,
she had to guess based upon results.
“After the procedure, I went home
and within 24 hours I could touch
my toes,” said Donlon, a running
enthusiast and marathon competi-
tor. “That’s when I figured I had the
study procedure. Within 48 hours,
I was back to work.” One year later,
the research team confirmed what
she suspected; she had undergone
the nerve ablation treatment.
The treatment uses radio frequen-
cy energy to disable the targeted
nerve responsible for low back pain.
Under local anesthesia with mild
sedation, through a small opening in
the patient’s back, an access tube is
inserted into a specific bony struc-
ture of the spine, called a vertebral
body. Radio frequency energy is
transmitted through the device, cre-
ating heat, which disables the nerve.
The access tube is then removed.
The minimally invasive, implant-free
procedure takes less than one hour.
“This is a new way to treat back
pain. This type of treatment has
never been done before,” Fischgrund
said. “It’s revolutionary compared to
more traditional therapies; the odds
of success are much greater.”
Patients eligible for this new
procedure typically are candidates
for more invasive back surgery or
take strong pain medications, like
opioids. Those research participants
who had the radio frequency abla-
tion procedure noticed significant
improvement in their back pain
within two weeks of surgery.
The nerve ablation procedure
and technology was developed
by Relievant Medsystems Inc., a
California-based medical device
company.
Nineteen months after Donlon’s
minimally invasive nerve ablation
treatment, she said, “Today, I have
no back issues. I’m pain-free. In fact,
since my procedure, the pain has not
recurred. I’m extremely grateful for
the care and treatment I’ve received
through my participation in the
lower back pain study.”
For more information about when
this procedure becomes available
at Beaumont, Royal Oak, email
ContactUs@beaumont.edu.
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