Research Studies Update

What’s going on in the Research department.

By Ted Swing, Ph.D.

The development of new treatments for pain depends on studies called clinical trials. Clinical trials are studies that typically take place at many locations around the country — sometimes around the world. The study is supported by a sponsor, but the treatments are overseen by doctors at each individual location. Clinical trials may study the effectiveness and safety of a new drug, a surgical procedure, or a medical device. At Arizona Pain, we are committed to advancing the treatment of pain, so we are taking part in several clinical trials.

Active Clinical Trials

St. Jude SENSE Study

Patients who have moderate to severe chronic pain that is not resolved by conservative treatments, such as rest, physical therapy, chiropractic care or medication therapy, may qualify for treatment with a device called a spinal cord stimulator. This is an implanted device that delivers electrical pulses to the nerves of the spine that disrupt pain signals, producing pain relief.St. Jude is conducting a study comparing the standard spinal cord stimulator to new type of device that stimulates both the spinal nerves as well as peripheral nerves in the lower back. The study is intended to test if patients who have had back surgery and continue to experience pain in the lower back and legs may get better relief from the combination system than the standard spinal cord stimulator.

Seikagaku Herniated Disc Study

The discs separating the spinal vertebrae can bulge outward, putting pressure on the nerve roots. When this happens in the lower back, it can cause pain and numbness that shoots down one or both legs.Seikagaku is studying a drug that is injected into the bulging disc that may be able to permanently shrink the bulging disc, relieving the pressure on the nerve root and the pain it causes. Patients who have suffered from back and leg pain due to a bulging disc for no more than one year and who have never had surgery in their lumbar spine may be eligible to participate. Of patients enrolled in this study, 75% receive an injection of this study drug and 25% receive a control treatment.

Pfizer Lyrica Post-Traumatic

Peripheral Nerve Pain Study

Traumatic injuries, such as car accidents, falls or even surgical procedures, sometimes leave patients with chronic nerve pain in the area of the injury. This can affect peripheral nerves, which are nerves outside of the head, neck or spine. Because this pain is due to damage or irritation of the nerve itself, it may last after the injury itself has healed. For example, a person may have injured their shoulder in a car accident and suffer chronic nerve pain that runs from their shoulder and into their arm.Lyrica is medication currently approved for several types of nerve pain. Pfizer is currently studying Lyrica for the potential to treat post-traumatic peripheral nerve pain as well. Patients who suffer from post-traumatic peripheral nerve pain may be eligible to enroll in the study and receive either Lyrica or a placebo medication for up to 17 weeks.

Pfizer Arthritis Cardiovascular

Disease Study

Osteoarthritis and rheumatoid arthritis are among the most common causes of chronic pain. Many patients with these conditions require treatment with anti-inflammatory medications, such as ibuprofen (e.g., Advil®), naproxen (e.g., Aleve®) or Celebrex®. There is some concern, however that these medications can increase the risk of cardiovascular problems in patients who are at risk.

Pfizer is conducting a large scale study at hundreds of sites around the world to determine which of these medications is safest for patients who are at risk of cardiovascular disease. Risk of heart disease is based on (a) coronary artery disease, (b) peripheral vascular disease, (c) diabete [if female, then diabetes requiring insulin] or (d) a combination of age, smoking, high blood pressure, family history of premature cardiovascular disease, and other risk factors. Patients who have osteoarthritis or rheumatoid arthritis that requires treatment with anti-inflammatory medication and meet one or more of the cardiovascular risk criteria may be eligible for this study. Patients enrolling in the study will be randomly assigned to receive one of three widely used arthritis medications (ibuprofen, naproxen, or Celebrex®) over the course of the study.

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 nine 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.