Low back pain is one of the most common complaints of aches and pains in our society today, according to the American Association of Orthopaedic Surgeons. Almost every person will have at least one episode of low back pain at some time in his or her life, especially as one begins to age. Now, a new study at Emory University is comparing a rehabilitative treatment to relieve pain and align bones with conventional physical therapy -- currently the standard treatment for chronic low back pain -- to determine if there is another non-surgical treatment alternative for patients with this ailment. Disc degeneration from both aging and wear and tear is a common cause of chronic low back pain. "This study is specifically designed for patients who have had chronic low back pain for more than three months that is brought on by degenerative or age-related disc disease," says Michael Schaufele, MD, assistant professor of orthopaedics, Emory University School of Medicine. "Rehabilitative equipment developed on the principle of traction is very popular. Several devices have been available for years, but the science to prove they work is very limited. This research study will look at an improved and advanced type of this therapy to see how it compares to physical therapy, the standard of care for chronic low back pain."
Participants in this research study will be selected to undergo six to 18 treatments of standard physical therapy over a six-week period, or six to 20 treatments of a new type of therapy called interferential disc dynamics (IDD) therapy over the same period of time. Standard physical therapy for low back pain consists of stretching, lumbar stabilization exercises and strengthening, as well as home exercises.
An FDA-approved medical device called the Accu-SPINA System administers IDD therapy. The Accu-SPINA System is designed to non-surgically relieve disc pressure. Through a computer-directed patient harness system that delivers manipulative forces, the device creates a decompression effect on the disc by means of a negative pressure state, or vacuum, within the disc. "In theory, this negative pressure may increase the water content of the disc, helping to rehydrate the disc," says Dr. Schaufele. "This effect may then increase the shock absorbing qualities of the disc while taking the pressure off the pain fibers, potentially resulting in decreased back pain."
Those in the IDD group will also undergo an oscillation treatment during each therapy session. The oscillation treatment (treatment with rhythmic movement) targets muscle groups surrounding the treatment site, in an attempt to relax the muscles following spinal manipulation therapy.
Dr. Schaufele and colleagues hope to enroll 50 participants in this research study. Prior to entering the study, all participants will be evaluated by an Emory Spine Center physician. They will be given questionnaires about their health and well-being, and will be rated on a pain and functional scale prior to beginning the study and at the end of the study. Once the study ends, participants will be reevaluated after six weeks, three months, six months and 12 months.
To enroll, study participants must have chronic low back pain for more than three months brought on by degenerative or age-related disc disease. They must be 18 years of age or older. And they must not have had any treatment for their pain within the past six weeks.
This study is partially funded by North American Medical Corporation, the maker of the Accu-SPINA System. All treatment sessions and office visits, however, will be charged to the patient or his/her health insurance.
For more information or to enroll in the study, please contact Emory Health Connection at 404-778-7777.