By Ted Swing, Ph.D
Clinical research studies are a critical tool for the advancement of pain medicine. They provide evidence that the Food and Drug Administration uses to decide if a new treatment is safe and effective enough to approve for use in treating a particular condition. These studies can also help convince insurers that the treatment is worth paying for.
Clinical trials often have very specific requirements that many patients — including those who suffer from the condition being treated — are not able to meet. Additionally, most studies involve randomization to treatments, which means some patients don’t get the treatment being studied. Nonetheless, there are a number of benefits for taking part in clinical research. In addition to helping improve pain medicine as a field, clinical trials may give patients access to treatments that are more effective than those currently available. Often study involvement poses little or no cost to patients beyond their time; in some cases, patients are even compensated for completing study visits.
Currently we are enrolling patients in several different clinical trials.
VertiFlex Totalis Research Study
Patients who experience pain that radiates down into their legs, particularly when walking or standing for extended periods of time, may have a condition called spinal stenosis. Spinal stenosis is the narrowing of the central canal through which the spinal cord runs. Stenosis can have multiple causes, but one common one is the thickening of a ligament that runs through the spine. Traditionally, this was treated with an open spine surgery. VertiFlex has developed a less invasive procedure, called the Totalis, that may be able to provide lasting pain relief for these patients. We are currently enrolling patients in a study of this procedure, but enrollment is expected to end soon.
Mesoblast CASCADE Research Study
Patients who experience low back with little or no radiating leg pain due to a condition called degenerative disc disease may be candidates for another study. This study targets those whose pain is due primarily to degeneration of a single disc. Patients must complete multiple steps to determine their eligibility for this procedure. Eligible patients receive a single injection of stem cells (taken from adult donors), stem cells and a growth factor called hyaluronic acid, or saline. These patients are then followed up for a year or more. Enrollment in this study is open and expected to continue for some time.
Grunenthal CRPS Research Study
In some cases, physical trauma (particularly to an extremity such as a hand or foot), can develop a condition called complex regional pain syndrome (CRPS). In this condition, the affected limb begins to experience changes in temperature, color and hair growth. It also becomes highly sensitized so that mild contact with the limb is extremely painful. Grunenthal is currently conducting a trial testing infusions of a new drug, neridronate, for patient CRPS. Eligible patients receive four infusions over two weeks containing a low dose of neridronate, a high dose of neridronate or saline only. Patients then complete multiple follow-up visits. Enrollment in this study will begin soon.
Neuros Altius Research Study
After the amputation of a leg, it is common to feel pain not only in the stump. In some cases, this pain is even perceived to be in the missing part of the leg, a phenomenon known as phantom limb pain. Neuros Medical has developed a new type of implanted device designed to treat the pain in an amputated leg by delivering high frequency electrical stimulation that blocks the nerves in the leg from conducting pain signals to the brain. Eligible patients will have this device implanted and will complete follow-up visits. For the first three months after implantation, half of patients will be randomly assigned to receive a therapeutic level of stimulation, whereas the other half of patients receive a non-therapeutic level of stimulation. However, after three months all patients receive therapeutic stimulation. Enrollment in this study will begin soon.
If you are interested in learning if you are qualified for one of these studies, 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 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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