Clinical Trial to Stop Chronic Lower Limb Pain
by Peter Staats, MD, MBA – Premier Pain Centers
It’s no secret that chronic pain is a growing health issue in the U.S. today. I see chronic pain patients every day in my practice at Premier Pain. Defined as pain lasting longer than six months after an injury has healed, it is estimated that more than 100 million Americans suffer from chronic pain annually.
Chronic pain can impact a sufferer’s ability to lead a productive working, social and family life. Many patients undergo years of testing and doctors’ visits without a longterm solution.
What Causes Neuropathic Pain?
Neuropathic pain is induced by an injury or disease of the nervous system. A common cause of neuropathic pain is post-surgical nerve damage, which occurs in up to 35 percent of patients who undergo hernia surgery and 50 to 85 percent of patients who undergo amputations. Other causes include nerve damage caused by trauma or diseases such as Complex Regional Pain Syndrome (CRPS).
Neuropathic pain is difficult to treat. Strong medications like opioids can provide relief, but may not always be an effective long-term treatment option.
What is Neurostimulation Therapy?
For many years, neurostimulation has been a well-accepted, effective, and safe method to treat neuropathic pain. Most popular is stimulation of the spinal cord. Leads (small wires) are implanted in the epidural space, an area around the spinal cord. A neurostimulator sends pulses to the leads. It is implanted in the abdominal wall or buttock, and is controlled via an external remote control.
What is the ACCURATE Study?
My offices in Shrewsbury, East Brunswick, and Brick are participating in a national study along with nearly two dozen sites across the country to evaluate a potential new therapy for chronic lower limb pain.
The investigational Axium™ Neurostimulator System is the only spinal cord stimulation system that targets a branch of spinal cord called the dorsal root ganglion (DRG). The Dorsal Root Ganglion (DRG) plays a critical role in the development and maintenance of chronic pain, as it processes pain signals as they travel to the brain.
By stimulating the DRG, the Axium System interrupts pain signals before they travel to the brain. Recently published European data from a nonrandomized study found that 78 percent of patients experienced pain relief in the lower limbs.
Premier Pain is now enrolling patients for the ACCURATE study, a prospective, randomized, multi-center, controlled trial to determine the safety and efficacy of the Axium™ Neurostimulator System for chronic neuropathic pain affecting their lower limbs (such as the leg, foot, or groin).
To qualify for the ACCURATE study, patients must fit the following inclusion/ exclusion criteria:
• Male or Female between the ages of 22 and 75
• Have had chronic pain affecting lower limbs for at least six months
• Have not seen lasting success with other treatments and
• Have not previously used spinal cord stimulation for chronic pain
For more information, or to see if you qualify for the ACCURATE study, please call 888-978-8397.
Dr. Peter Staats is a Board Certified Pain Management Specialist practicing at Premier Pain Centers in Shrewsbury, East Brunswick, and Brick. He has been consistently recognized as one of the country’s foremost pain management doctors. This includes being named one of America’s Top Doctors by U.S. News and World Report for the last decade, noted as being among the top 1% of pain management physicians in the country.
CAUTION: The Axium Neurostimulator System is an investigational device and is limited by United States law to investigational use.