Clinical researchers test a variety of new treatments for various medical conditions. Those that prove successful receive approval and eventually become a part of the standard treatments for that condition. This research is incredibly important and we are committed to advancing the practice of pain medicine by taking part in clinical trials, in areas such as lower back pain and phantom limb pain. We are currently enrolling certain selected patients in several clinical trials in Phoenix, AZ and following up their progress for a specified period of time.
Stem cells for lower back pain clinical trials
Lower back pain is the most common chronic pain condition. There are several different causes, such as degeneration of the bones in the spine, misalignment of the vertebrae, or the bulging of an intervertebral disc. In other cases, a disc becomes degenerated and begins to cause pain. This can be associated with a distinct event such as an injury, but in many cases there is no clear cause. This condition, degenerative disc disease, is a common form of back pain, but it has proven difficult to treat effectively.
One promising new line of research involves treating this condition with an injection of stem cells into the degenerated disc. Adult bodies contain stem cells that play an important role in rebuilding damaged tissues, but these cells are not normally able to reach the inside of the disc.
We are taking part in an ongoing clinical trial for lower back pain. The sponsor has developed a process for separating the stem cells from the bone marrow of healthy adult donors and allowing them to multiply. These stem cells can then be injected into a degenerated disc. Some early evidence indicates that this can restore the degenerated disc to a healthy state, alleviating pain. This treatment is being assessed in a clinical trial in which qualified patients are randomly assigned to receive a single injection into a degenerated disc of either stem cells, stem cells plus a growth factor called hyaluronic acid, or saline (a control/placebo injection).
High-frequency stimulation clinical trials
We are currently working on two clinical trials testing new types of implanted medical devices. In cases where pain does not respond to other treatments, it is sometimes treated with implanted devices called neurostimulators. These work by delivering electrical stimulation to the nerves that blocks out much of the pain signals that would be sent to the brain. The current standard neurostimulation devices deliver stimulation at a low to moderate frequencies that produces a mild tingling sensation in the targeted area that some patients find unpleasant or sometimes painful. A new type of neurostimulators deliver high frequency stimulation (10,000 Hz) to the nerves. This blocks out some or all of the pain from the targeted region of the body. High frequency stimulators have the advantage of causing no sensation in the targeted area. Some early research suggests that high frequency stimulation can be even more effective in alleviating pain.
Phantom limb 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). The current clinical trial is testing the device in patients who have had an amputation of a single lower limb that is causing them chronic pain. Qualifying patients will have this new device implanted. For a three-month period, half of these patients will receive high frequency stimulation and half will receive control stimulation. After that period, all implanted patients will have their device adjusted to deliver the high frequency stimulation as follow up continues.
Post-surgical nerve pain study
Surgical procedures can sometimes damage or irritate nerves, causing persistent pain in the affected area. We’re taking part in a clinical trial in Phoenix, AZ of a different device designed to deliver high frequency stimulation to the spinal cord. This study is specifically for pain that (a) resulted from a surgical procedure, (b) is chronic nerve related pain, (c) affects a focused area (e.g., a knee) in the upper extremities (shoulders, arms), trunk (chest, abdomen), or lower extremities (hip, knee). Though it is common to experience post-surgical pain after spine surgery, such patients are not eligible to take part in the current study. Those who qualify for this study will have a neurostimulation device implanted with the leads running along the spinal cord. Patients will be followed up for one year to assess the effectiveness of this device in relieving pain.
If you are interested in learning more about one of these clinical trials in Arizona 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.
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