Ohio researchers receive NIH grant to study treatments for lower back pain

(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), and 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).  

“The 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.

The 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.

“This is 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 include:

·         David Russ, P.T., Ph.D., assistant professor the Division of Physical Therapy in the School of Rehabilitation and Communication Sciences, a physical therapist with expertise in exercise and skeletal muscle physiology;

·         Christopher France Ph.D., professor in the Department of Psychology, a psychophysiologist with expertise in chronic pain and pain-related fear;

·         Masato Nakazawa Ph.D., a biostatistician in the OU-HCOM Office of Research and Grants;

·         Stevan Walkowski, D.O., assistant professor in the Department of Osteopathic Manipulative Medicine at OU-HCOM, a physician with expertise in the treatment of low back pain;

·         Daniel Corcos, Ph.D., professor in the Department of Kinesiology and Nutrition at the University of Illinois at Chicago, a neuroscientist with expertise in randomized clinical trials; and

·         Guang Yue, Ph.D., director of the Human Performance and Engineering Laboratory at the Kessler Foundation Research Center, a physiologist with expertise in neurophysiology and magnetic resonance imaging.

In 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.

“This 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.”