Back it Up
By Ted Swing, Ph.D.
The most common form of chronic pain, affecting of millions of Americans, is low back pain. Low back pain can have a number of causes. One of the most common is a condition called spinal stenosis. Spinal stenosis refers to a narrowing of the spaces in the spine. This narrowing can result in pressure on the nerve roots that pass through the spine, causing pain and numbness that may radiate downwards (e.g., into the legs). We will be taking part in a new clinical trial for the treatment of pain caused by spinal stenosis of the lumbar spine.
Current Treatments for Spinal Stenosis
It is often best to begin treating low back pain with conservative treatments, such as rest, ice or cold, physical therapy, or chiropractic care. Patients also take various medications to help control this pain. Epidural steroid injections also help some patients with spinal stenosis. If all of these treatments fail to control the pain, patients may have no other option than surgery, such as a spinal decompression procedure. In this procedure, small pieces of bone and ligament tissues are surgically removed from the narrowed part of the spine, relieving the pressure on the nerve root and the pain it causes.
New Treatment for Spinal Stenosis
Vertiflex has developed a new system for treating spinal stenosis called the Totalis Direct Decompression System. This system involves very small tools and enables doctors to operate through a small incision in the back. Compared to the standard spinal decompression procedure, this affects a smaller portion of tissues. This system could help the spine keep its stability better than surgery. Recovery time may also be shorter than with an open surgical procedure.
New Clinical Trial
Vertiflex will be testing this new system in a clinical trial approved by the Centers for Medicare & Medicaid Services (CMS) for treating primarily Medicare patients. Patients who take part in the study will be randomly assigned, with two-thirds (67%) receiving treatment with the Totalis Direct Decompression System and the other one-third (33%) receiving no study intervention. Because this is a double-blind study, patients and most study staff will be not be told whether a patient is receiving the study procedure during the study. Patients will then be followed up seven times over the next two years to assess the treatment’s efficacy in relieving pain and improving physical function.
Who is Eligible to Enroll?
Patients age 55 to 85 who have pain, numbness, tingling, and/or burning in the legs, buttocks, and/or groin caused may be eligible to take part in this study. Patients must have a diagnosis of central canal spinal stenosis in the lumbar spine (lower back), based on imaging (e.g., MRI). Eligible patients will often experience moderate to severe pain when they stand or walk and may experience relief when they sit or bend over. In order to enroll patients must have experienced these symptoms for over 6 months and failed to get relief from conservative treatments (e.g., physical therapy), medications and epidural steroid injections.
This clinical trial is expected to begin in the next few months. If you are interested in learning more about this study, you can speak with your pain management providers or contact me directly at [email protected].
Ted Swing has more than nine years of research experience and four years of teaching experience in psychology, has published in top psychology and medical journals, and has presented his research at major conferences. He received his Ph.D. in Social Psychology from Iowa State University and has been the Research Director at Arizona Pain since May 2012.