Broward County Edition | August/September 2009

VOL. 1, NO. 3

Dealing With
Matters ofCardiology
the HeartAssociates of
Fort Lauderdale Reigns Supreme

Fighting Back Against Chronic Pain
One of the
foremost re-
sea rc hers i n
chronic pain
and sleep dis-
orders, Victor
Rosenfeld,
M.D., is on the
Victor Rosenfeld,
M.D.
leading edge of
research initia-
tives in many areas.
A graduate of the Emory University
School of Medicine, Dr. Rosenfeld’s
medical training also includes an in-
ternal medicine residency completed
at Alton Oschner Medical Foundation
and a neurology residency completed at
the University of Miami. Board certi-
fied in neurology and sleep medicine,
Dr. Rosenfeld has played a key role
in the advancement and study of
chronic pain and its connection to
sleep disorders.
Now serving in the neurology de-
partment at the Sansum Clinic in Santa
Barbara, CA, Dr. Rosenfeld offers M.D.
News some insight into one of his latest
clinical trials.
Q: How has interest in the study
of fibromyalgia changed in recent
years?
Dr. Rosenfeld: The amount of
research in fibromyalgia and chronic
fatigue has literally exploded in an
exponential way over the past 10
years, with peer-reviewed references
increasing from just a handful to liter-
ally thousands per year. We are also
beginning to understand the role
of sleep on multiple body systems,
including cardiovascular, endocri-
nologic, psychiatric, neurological,
immunologic and even ophthalmologic
and renal systems.
1 6 | broward county m.d. news august/september 2009
W e just completed
a Phase III,
548-patient, international
multisite trial, which
w a s a r a n d o m ize d ,
d o u b l e - b lin d e d a n d
placebo-controlled study
looking at the effects
of sodium oxybate in
pain, fatigue and quality
of life in patients with
fibromyalgia.
— Victor Rosenfield, M.D.
Q: What role has technology
played in the advancement of sleep
studies?
Dr. Rosenfeld: Sleep studies, which
used to be recorded entirely on paper,
are now fully computerized, which has
given us amazing new tools to analyze
vast amounts of data. In our lab we use
quantitative EEG (qEEG) technology,
which allows us to accurately measure
all the brain waves of patients while
they are asleep, which previously had
not been possible. It is new tools such
as this that allow us not only to identify
different types of sleep pathology, but
also possibly even measure responses to
interventions in a way that previously was
not possible.
Q: Can you explain some of your
current clinical trials, including
the multisite International Phase
III Trial?
Dr. Rosenfeld: We just completed
a Phase III, 548-patient, international
multisite trial, which was a randomized,
double-blinded and placebo-controlled
q&a
study looking at the effects of sodium
oxybate in pain, fatigue and quality of
life in patients with fibromyalgia. The
early data looks quite impressive, and
some of the data has been released at
recent medical meetings with major
publications forthcoming. I have also
been publishing some work on how
patients with fatigue and fibromyalgia
can be identified during sleep studies
using qEEG technology and also how
this same methodology may be able to
demonstrate treatment responses in
objective, reproducible ways.
Q: What do you see as the ulti-
mate goal of studies such as the
International Phase III trial?
Dr. Rosenfeld: There are cur-
rently two antidepressants and one
anticonvulsant that are FDA approved for
the treatment of fibromyalgia, which can
help reduce the pain these patients experi-
ence by modulating the way the nervous
system processes signals. However, based
on some of the original sleep research
mentioned previously, we are now look-
ing at experimental sleep medications in
these patients that can improve not only
pain, but also fatigue and sleep quality.
This could lead to a paradigm shift in
our treatment approaches in that a new
sleep medication may be a novel therapy
for patients with chronic pain that differs
significantly from standard approaches
used today. n
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