ACCURATE Clinical Study May Be Chronic Pain Answer
By Dr. Stanley Golovac, Florida Pain // November 9, 2013
you may be candidate for ACCURATE Clinical Study
Chronic pain, defined as pain lasting longer than 6 months, affects almost one in five adults. Chronic pain can impact nearly every aspect of daily life – from work performance, to family life, to social interactions.
If you are like many chronic pain sufferers, you have probably tried multiple approaches to relieving your pain, and may be using medications regularly to manage your symptoms.
If you suffer from chronic pain affecting your lower limbs (such as the leg, foot, or groin), but have not had lasting success with other treatments for your pain, you may be a candidate for the ACCURATE Clinical Study. The study is evaluating the Axium™ Neurostimulator System – an investigational device designed to provide targeted relief of chronic pain.
What Causes Lower Limb Pain?
Millions of people struggle with chronic pain affecting their lower limbs, such as the leg, foot, or groin. Oftentimes, this chronic pain is the result of nerve damage or nerve dysfunction (also called neuropathic pain). Unlike other types of pain, neuropathic pain can be quite severe, and is more likely to be chronic and less responsive to pain medications.
Some of the conditions that cause chronic lower limb pain include:
• Complex Regional Pain Syndrome (CRPS) – This is a chronic pain condition that often affects the extremities, including the legs and feet. It can cause intense pain such as burning, tissue swelling, and sensitivity to touch – that may get worse over time. CRPS is also known as Reflex Sympathetic Dystrophy (RSD) Syndrome.
• Nerve Damage – Any cause of nerve injury, from surgeries to trauma, may result in persistent pain that is difficult to treat. For example, more than 30% of patients who undergo surgery to fix a hernia may suffer from long-term, chronic groin pain. Pain due to nerve damage is quite varied depending on the location (foot, groin, leg), and can include numbness, throbbing, or stabbing pain.
Since these and many other conditions can cause chronic lower limb pain, it is important that you work with a doctor to diagnose the root cause, and develop a treatment plan that is tailored to your specific pain.
What is Neurostimulation Therapy?
The sensation of pain is felt when your body sends a pain signal to your brain. With chronic pain, that pain signal can continue even after the original cause of the pain has been treated and resolved.
Neurostimulation is a technique for treating chronic pain that uses a small implanted system called a neurostimulator. The neurostimulator delivers mild electrical signals to the nerves in your spinal cord. These signals replace the original pain signal with a tingling or massaging feeling that covers the specific areas where you feel pain. FDA-approved neurostimulators have been used to treat over 300,000 patients.
What is the AxiumTM Neurostimulator System?
The Axium Neurostimulator System is an investigational device for the treatment of chronic pain, developed by Spinal Modulation, Inc. (www.spinalmodulation.com)
The Axium System is a form of neurostimulation that targets a specific branch of the spinal cord called the Dorsal Root Ganglion (DRG). The DRG acts like a traffic light that controls when sensations enter the spinal cord. It is believed that stimulation of the DRG may serve as a stoplight, preventing pain signals from traveling to the brain.
Like other neurostimulator systems, the Axium System comes with a handheld “remote control” that lets you adjust the strength of the stimulation, and turn the stimulator on or off. An important feature of all neurostimulator systems is that you can try it for a period of time before you have it implanted. The temporary system works similar to the implanted system, so you can experience how the treatment works for you. If after the trial period you and your doctor are satisfied with the pain relief, you can choose to have the system implanted through a minimally-invasive, outpatient surgical procedure.
What is the ACCURATE Study?
The ACCURATE Study is a prospective, randomized, controlled multi-center study that is designed to evaluate the safety and effectiveness of the AXIUM System for the treatment of chronic lower limb pain. Study participants will be randomized to receive one of two neurostimulation systems, the AXIUM System or a commercially available neurostimulator system.
Who Qualifies For The Study?
To see if you might qualify for the ACCURATE Clinical Study, and to be referred to me at FLORIDA PAIN, please take a moment to complete the pre-screening questionnaire online at www.accuratestudy.com or call 1-888-978-8397 to speak with a study specialist.
Key study qualifications include the following:
• Age 22-75 years
• Chronic Pain affecting lower limbs (leg, foot, or groin) for at least 6 months
• Have not had lasting success with other treatments for chronic lower limb pain
• Have not tried neurostimulation for chronic pain
• Willing to attend regular follow-up visits over a 5-year period
The pre-screening questionnaire is the first step toward participating in the ACCURATE Clinical Study.
The questionnaire will help determine if you meet some of the main criteria for the study. If you meet the pre-screening criteria and would like to hear more about the study, you will be given the option to have your contact information sent directly to us at Florida Pain.
Our ACCURATE clinical study coordinator, Susan Clark, ARNP-C, will then contact you within a few days to tell you more about the study, complete the screening process and answer any questions you might have. Only your local study site staff can make the final determination on who qualifies for the study.
595 N. Courtenay Pkwy
Merritt Island, FL 32953
ABOUT THE AUTHOR
Dr. Stanley Golovac completed his education at UTESA University in 1985, where he received his Doctor of Medicine. Upon graduation, Dr. Golovac completed his postgraduate training in Family Practice Residency Program at St. Mary Hospital in New Jersey and in the Department of Anesthesiology at Jackson Memorial Hospital in Miami.
Dr. Golovac gained extensive clinical experience in anesthesiology, emergency room medicine, and alternative services. He served as Assistant Clinical Professor of Anesthesia at the University of Miami Jackson Memorial Center for several years, and then as a practicing Pain Consultant in the Miami area. He currently utilizes his expertise at Florida Pain, Merritt Island Surgical Center and Space Coast Surgery Center (located at our facility).
Dr. Golovac is a Diplomat of the American Board of Anesthesiology and the Board of Pain Management. He is certified by the Educational Commission of Foreign Medical Graduates, Federal License Examination and in Basic Life Support and Advanced Cardiac Life Support. He is a member of the American Academy of Pain Management, International Anesthesia Research Society, American Society of Anesthesiologists, and Florida Society of Anesthesiologists.
Dr. Golovac is also a member of the American Medical Association, and a current recipient of the AMA Physician’s Recognition Award Certificate (AMA PRA). This certificate recognizes physicians who complete at least fifty hours of continuing medical education annually.