Clinical trial researchers test a variety of new treatments for various medical conditions. Clinical trials that prove successful receive approval and eventually become a part of the standard treatments for a certain pain condition. This research is incredibly important, and at Arizona Pain, we are committed to advancing the practice of pain medicine by taking part in clinical trials. We are currently enrolling certain selected patients in several clinical trials and following up their progress for a specified period of time.
RADIANT clinical trial
We are currently enrolling patients in several clinical trials testing the latest neurostimulation devices, such as spinal cord stimulators (SCS). These implanted medical devices function much like cardiac pacemakers, except that instead of affecting the heart, they use electrical pulses to reduce or eliminate pain.
For years, making adjustments to the level of stimulation required part of the controller to be held against the skin in the area the device was implanted (often the side of the low back area). St. Jude Medical has recently developed a spinal cord stimulator that can be adjusted via a Bluetooth signal from Apple mobile devices, potentially making the process of adjusting the device more convenient.
Additionally, these St. Jude Medical SCS devices are capable of delivering both the traditional tonic stimulation (which produces a tingling sensation in the region targeted for pain relief) as well as burst stimulation. Burst stimulation involves very rapid, short pulses of electrical stimulation. The speed of the pulses means that the patient does not experience the tingling sensation, potentially increasing the comfort of the stimulation for some patients who are bothered by the tingling sensation. We are taking part in the RADIANT study, a non-randomized study with St. Jude Medical to evaluate the comfort and efficacy of these newest devices. Patients who are identified as candidates for spinal cord stimulator therapy may be invited to take part in this study.
Dorsal root ganglion stimulation study
Traditional spinal cord stimulators have proven effective in treating many types of chronic pain that do not respond to other treatments such as medications, injections, and surgeries. A spinal cord stimulator includes special wires called leads that are implanted along the center of the spinal cord, an area known as the dorsal column. This placement is ideal for treating many of the most common types of pain, such as pain that radiates down from the spine into the legs. For certain types of chronic pain, however, the pain has proven difficult to treat with these devices. For example, some types of pain affect only the feet. Traditional neurostimulation devices would stimulate the entire leg in order to relieve this foot pain and might be uncomfortable for some patients.
Recently, St. Jude Medical received FDA approval for a new type of neurostimulation device targeting clusters of nerves, called the dorsal root ganglion (DRG), near the place where nerves branch off from the spinal cord. By targeting stimulation at the dorsal root ganglion (DRG), it allows more selectivity in the affected areas. This can make the stimulation more comfortable and effective for certain patients (e.g., stimulating the feet while leaving the rest of the legs unaffected). We are currently enrolling patients in this clinical trial who are good candidates for DRG stimulation in the St. Jude Medical TARGET study to further assess the efficacy of this treatment.
Peripheral amputation pain study
Patients who have undergone the amputation of a foot or leg sometimes continue to experience chronic pain, either in the stump of the amputated limb or phantom limb pain (pain perceived to be in the missing portion of the amputated limb). We are currently taking part in randomized clinical trials testing a temporary implantation of a device in patients with chronic pain due to the amputation of one or both lower limbs.
Qualifying patients will have this new device implanted in the leg for eight weeks. For the first four weeks, patients will be randomized to receive either therapeutic stimulation (which should relieve pain) or non-therapeutic stimulation (which should not relieve pain). For the next four weeks, all patients will receive therapeutic stimulation. Patients will then have the device removed and will be followed up for 12 months to ensure that there are no adverse effects.
If you are interested in learning more about one of these clinical trials and whether you might qualify for it, you can discuss this study with your pain management providers. For additional information about this study you can contact me directly at TedS@arizonapain.com.
Ted Swing has 13 years of research experience in psychology and pain medicine and four years of teaching experience, 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.