On the Front Lines – Clinical Research Update

The field of pain management depends on clinical research to assess the efficacy of available treatments as well as to develop new treatments. At Arizona Pain, our clinical research helps us lead the way in advancing the science of pain treatment. We have several clinical trials for which we are actively recruiting patients.

St. Jude SENSE Study

Spinal Cord Stimulators (SCS) are devices implanted along the spine for treating chronic pain. These devices deliver carefully controlled electrical pulses to disrupt the pain signals passing through the spinal cord, replacing them with a non-painful tingling sensation. These devices help many patients who did not get relief from other interventions or surgical procedures.

We are taking part in a study with St. Jude Medical, one of the leaders in designing spinal cord stimulators, to test a new type of device. Certain types of pain can be difficult to completely cover with a spinal cord stimulator. The device being tested in this study includes a lead along the spinal cord as well as two leads that extend out into the low back and stimulate the nerves in that area. The study is designed to test if these additional leads provide greater pain relief for certain types of patients than the spinal cord leads alone. Patients enrolled in this study receive either a traditional spinal cord stimulator or a combination system with both spinal cord and peripheral leads.

Saluda Medical Study

Another challenge in spinal cord stimulation is to deliver the same level of perceived stimulation. Often the tingling sensation produced by a spinal cord stimulator may become stronger or weaker depending on body position (e.g., standing vs. sitting). Patients can adjust this stimulation, but they may briefly experience too much or too little stimulation. Saluda Medical is currently developing a spinal cord stimulator that can sense increases or decreases in the stimulation being delivered and automatically adjust to keep it at a comfortable level.

This brand-new technology is currently being tested in a short 20 -day trial. Before undergoing permanent implantation of a spinal cord stimulator, patients must test out a trial system for several days. Patients enrolling in this study will undergo the normal trial before switching over to the study device for 20 days. During this time, they will receive normal stimulation for 10 days and the automatic feedback adjusted stimulation for 10 days.

VertiFlex Totalis Study

One common cause of back and leg pain is spinal stenosis. In this condition, the canal through which the spinal cord passes narrows to the point that it puts pressure on the spinal cord, causing pain that radiates to the extremities. When patients have spinal stenosis in their lower back, they often feel this radiating pain the longer they walk and get relief from leaning forward or sitting. Patients often receive epidural steroid injections for this condition. When they do not improve, they have traditionally undergone a surgical procedure.

VertiFlex is working with Medicare on a study of a less invasive procedure called the Totalis procedure that they have developed for treating lumbar spinal stenosis for patients age 55 to 85. In a traditional spinal surgery, parts of the bones and other tissues in the spine are removed to make room for the spinal cord. Because of the amount of tissue removed or otherwise disrupted, recovery can be longer and may contribute to other spinal problems in the long run. In the Totalis procedure, a small metal tube is inserted between the bones of the spine and a small amount of tissues is removed through this tube under x-ray guidance. Because this procedure is minimally invasive, it may provide for faster recovery and less disruption of the spine than traditional spine surgery. Two-thirds of patients who enroll in this study will receive this Totalis procedure and one third will receive a non-therapeutic control procedure. However, for patients receiving the control procedure who continue to experience significant pain, they may exit the study and VertiFlex will provide the Totalis procedure.

If you are interested in learning more about any of these studies, you can speak with your pain management providers or contact me directly at TedS@arizonapain.com.

Ted Swing has more than ten 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.