By Ted Swing, Ph.D.
Clinical research is a critical part of advancing medical treatments of chronic pain. As part of our commitment to leading the way in cutting-edge treatments for pain, Arizona Pain will be recruiting patients to take part in two potentially groundbreaking new clinical trials.
VertiFlex Totalis Trial
One very common pattern of chronic pain is pain in the lower back that radiates down into one or both legs. In many cases, this pain is increased when standing or walking and may be relieved by sitting and leaning forward. This can be a sign of a condition called spinal stenosis. Spinal stenosis refers to a narrowing of space in the spine through which the spinal cord or nerve roots run. For example, one of the ligaments found in the spine, the ligamentum flavum, may become thicker for some individuals, causing a decrease in the space in the central canal of the spine. When the space becomes narrow, the spine can put pressure on the nerves, causing radiating pain and other symptoms such as numbness. In addition to the pattern of symptoms, stenosis is typically identified through magnetic resonance imaging (MRI).
In many cases, such radiating pain is relieved by conservative treatments, such as rest, medications, chiropractic care and epidural steroid injections. When this pain persists after multiple forms of conservative care, additional treatments may be required. Traditionally, this has meant a surgical procedure called decompression. In this procedure, some bone and ligament in the area of the narrowing are removed to relieve the pressure causing the pain and/or numbness. This treatment is often effective, but one of the downsides is that, as an open surgical procedure, it requires removing tissue to the extent that a person may be more likely to experience other back problems in the future.
By comparison, a new procedure developed by VertiFlex may provide these patients with relief through a much less invasive procedure. This procedure uses their Totalis system to access the spine through a small incision using imaging to guide the precise removal of a small amount of ligament tissue. This can provide relief of patient’s symptoms while better maintaining the stability of the spine.
We are conducting a Medicare approved trial of the Totalis procedure with VertiFlex. Medicare patients between the ages of 55 and 85 who have radicular leg pain due to central canal stenosis of the lumbar spine may be eligible to take part in this trial. Some non-Medicare patients in this age range may also be eligible. Patients who qualify and enroll in this study will be randomized — two-thirds will receive the Totalis procedure and one-third will receive a control procedure, though patients and most study staff will not know which procedure was performed during the study. These patients will then complete multiple follow-up assessments over a period of one to two years.
Saluda Medical Feedback Study
Spinal cord stimulators (SCS) are implanted devices that relieve pain through electrical pulses delivered to the nerves. This stimulation replaces some of the painful sensations with a mild tingling sensation. These devices are sometimes described as being like a cardiac pacemaker, but for pain. They have been used successfully for years, but researchers continue to work on improvements. For example, for some patients the normally mild tingling sensation produced by a spinal cord stimulator can become too weak or too intense when the patient changes body positions (standing up vs. sitting down) or when coughing or laughing.
Researchers at Saluda Medical have identified a possible way to alleviate this problem. They have recently developed a specialized spinal cord stimulator trial system that uses the leads not only to deliver electrical pulses, but also to constantly measure how efficiently the pulses are being conducted to the nerves. This efficiency vs. resistance can indicate when the stimulation will be perceived as too weak or too strong. The device can automatically adjust the stimulation to keep it at a comfortable level based on this feedback.
Patients who qualify for a spinal cord stimulator first have a trial system implanted for three to seven days to see if the system provides them with adequate relief. If they do experience sufficient relief, this trial system is normally removed as the patient awaits the permanent device implantation. We are conducting a study with Saluda’s SCS trial system that will take place between the standard SCS trial and the permanent SCS implantation. After a successful SCS trial, qualifying patients who choose to take part will receive a Saluda trial system for 20 days. These patients will receive normal stimulation from this trial device for 10 days and stimulation that automatically adjusts based on electrical feedback for another 10 days. Study participants will complete several visits to the clinic to assess the device efficacy during this time. At the end of this 20 day period, the trial system will be removed and the patient can proceed with the permanent SCS implantation.
If you are interested in learning more about either 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.
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