Ohio researchers receive NIH grant to study treatments for
(ATHENS, Ohio – Oct. 1, 2012)
Approximately 60 to 90 percent of U.S. residents will experience lower back
pain over the course of their lives. Recent reports indicate that annual
costs related to low back pain exceed $90 billion in medical expenses,
missed work and lost productivity.
In a step towards finding more effective treatments for lower back pain,
two Ohio University researchers,
James S. Thomas, P.T., Ph.D., and
Brian C. Clark, Ph.D., recently received a five year, $2.1 million grant
from the National Institutes of Health (NIH) to fund “The RELIEF Study,”
which stands for Researching the Effectiveness of Lumbar
Interventions for Enhancing Function Study. Thomas is a
professor of physical therapy and director of research in the Division of
Physical Therapy, in the School of Rehabilitation and Communication Sciences
at the Ohio University College of Health Sciences and Professions (CHSP),
Clark is a professor of physiology in
the Department of Biomedical Sciences and director of the Ohio
Musculoskeletal and Neurological Institute (OMNI) at the Ohio University
Heritage College of Osteopathic Medicine (OU-HCOM).
study will look at the mechanisms
and effectiveness of three different non-surgical interventions used
to treat chronic low back pain. It will determine both the physiological
effects and clinical effectiveness of the treatments at reducing pain and
disability,” said Clark.
“The idea behind the study, in part, grew out of my earlier NIH-funded
study that investigated the neuromuscular mechanisms underlying motor
behavior in people with low-back pain. This builds on these previous results
by examining several therapeutic interventions commonly used to treat low
back pain and to look as some of the neurophysiological mechanisms that
underlie these treatments. Understanding these basic mechanisms will help to
enhance the decision-making process of when to use one intervention or
another,” said Thomas.
The RELIEF Study is OMNI’s first foray into large, randomized clinical
trials, said Clark. It will include 162
people with lower back pain randomly assigned to one of three of the
treatment groups. To prevent bias in measuring the effects of these
treatment interventions, the research scientists will not know the treatment
any study participant is receiving. “This information will only be known by
the treating clinicians and the research coordinator. This level of
‘blinding’ is a critical component in a randomized clinical trial and
minimizes the potential for experimenter bias,” Thomas said.
researchers will use a number of techniques to assess the effects of the
treatments on a variety of physiological outcomes. For instance, they will
use transcranial magnetic stimulation to assess the excitability of the
portion of the brain that controls the low back muscles. They will use
magnetic resonance imaging to determine if the treatments are able to reduce
muscle hyperactivity in the low back region, and finally, they will use
sophisticated biomechanical instrumentation to examine how the low back
muscles are activated, and how the spine moves, during various tasks. Each
of the study participants will receive one of the three non-surgical
interventions over a period of three weeks.
a synergistic effort that has been building for several years,” said Clark.
The study not only builds on Thomas’ previous study but also the work of
researchers involved in OMNI’s Low Back and Chronic Pain Disorders Research
Program. Recent work performed in
Clark’s Neuromuscular Physiology Laboratory and in Thomas’ Motor Control
Laboratory has focused on pioneering and developing a number of techniques
to measure physiological properties of the low back muscles. “We have
published several articles recently on these techniques, and now [with
this grant] have the ability
to do extend this work into a robust clinical trial,” Thomas said.
Importantly, This project also brings together a
multi-disciplinary team of researchers from Ohio University, the Kessler
Foundation Research Center in New Jersey and the University of Illinois at
Chicago. In addition to Thomas and Clark, key personnel for The RELIEF Study
Russ, P.T., Ph.D., assistant
professor the Division of Physical Therapy in the School of Rehabilitation
and Communication Sciences,
physical therapist with expertise in exercise and skeletal muscle
Christopher France Ph.D.,
professor in the Department of Psychology, a psychophysiologist with
expertise in chronic pain and pain-related fear;
a biostatistician in the OU-HCOM Office of Research and Grants;
assistant professor in the Department of Osteopathic Manipulative Medicine
at OU-HCOM, a physician with expertise in the treatment of low back pain;
professor in the Department of Kinesiology and Nutrition at the University
of Illinois at Chicago, a neuroscientist with expertise in randomized
clinical trials; and
director of the Human Performance and Engineering Laboratory at the Kessler
Foundation Research Center, a physiologist with expertise in neurophysiology
and magnetic resonance imaging.
addition to these individuals, a number of osteopathic physicians and
physical therapists will serve on The RELIEF Study Treatment Provider Team.
These clinicians will supervise and provide the treatment interventions when
the trial begins in the spring of 2013.
grant will allow for collaboration between physicians in OU-HCOM and the
physical therapists in CHSP who comprise our treatment team. This is
particularly important because the interventions being studied are used
extensively by both osteopathic physicians and physical therapists in the
treatment of low back pain, ” said Clark.
“This is a very substantial grant in a time when
less than 10% of applications are being funded at the NIH. Through a very
rigorous process of peer review we’ve been able to get a sophisticated study
funded that should provide important answers and help direct future
interventions in the treatment in low back pain,” Thomas said. “Low back
pain is a clinically significant problem and we are uniquely positioned to
take a multidisciplinary approach to address this problem.”