St. Jude Medical Invisible Trial Comparative Study

From the Lab
By Ted Swing, Ph.D.

One of the rapidly advancing areas in the treatment of chronic pain is the use of implantable neurostimulation devices. The most common of these are spinal cord stimulators. These devices are typically used in patients who have failed to get adequate relief from medications and conservative treatments such as physical therapy and chiropractic care. Patients who have had surgical procedures in the spine without obtaining relief may also be appropriate candidates for these treatments.

What is a spinal cord stimulator?

Spinal cord stimulators (SCS) are devices that typically consist of one or more leads with multiple electrodes. These leads are placed in the spine along the cord of nerves that transmits pain signals to the brain. These leads connect to a battery that generates electrical pulses in the leads. These electrical pulses are calibrated to disrupt pain signals coming from a particular body region, such as the lower back and legs. Patients with a spinal cord stimulator will feel a mild tingling sensation in place of the pain they normally feel.

Spinal cord stimulator trial systems

Before permanently implanting a spinal cord stimulator, patients will spend several days with a trial system. This system functions much like the permanent spinal cord stimulator system, but only the leads are implanted. The leads run through the patient’s incision site to an external stimulating system. Trying this system allows the patient to find out if the spinal cord stimulator will provide them with pain relief using a temporary system that can be easily removed at the end of the trial. This trial typically lasts about five days and then the trial system is removed. If the patient receives good pain relief, they can have a permanent spinal cord stimulator system implanted.

St. Jude Medical Invisible Trial System

St. Jude Medical is a leader in developing spinal cord stimulator systems. They recently developed the Invisible trial system. Unlike the current trial systems which have a cable connecting the lead to the external stimulator, this system has the lead connected to a Bluetooth device at the incision site. This Bluetooth device wirelessly connects to a controller that the patient can use to turn the stimulation on and off and make other adjustments. This new trial system is being studied and is not yet commercially available.

Invisible Trial System Study

We will be working with St. Jude Medical this spring to test this new system to see if patients find it more convenient than the current trial systems. Eligible patients who are getting a spinal cord stimulator trial can enroll in this study. They would complete the normal trial, except that they would use the current trial system for the first few days before switching to the Invisible trial system for the final few days of the study. They would provide feedback about each system.

If you are interested in getting a spinal cord stimulator, you can speak with your pain management providers. For additional information about this study you can 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.