This important study will expand the available information on the importance of FDA-approved Medtronic neurostimulation therapy for the many patients who experience persistent pain following back surgery
Stockbridge, Georgia (PRWEB) March 31, 2013
Pain Care, LLC is now enrolling patients to participate in PROMISE, a Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain. PROMISE is the first-ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy plus optimal medical management (OMM) to the administration of OMM alone in patients with failed back surgery syndrome (FBSS) and predominant low back pain.
More than 100 million U.S. adults are estimated to live with chronic pain. Back pain is the most prevalent type of chronic pain, affecting approximately 10 percent of the U.S. population.2 FBSS is defined as persistent or recurring pain in the back and/or legs following one or more spine surgeries. The majority of FBSS patients receive physical rehabilitation and/or medications to help manage their pain, but studies and clinical experience have shown that many of these patients will not sufficiently improve and require additional interventions.3
“This important study will expand the available information on the importance of FDA-approved Medtronic neurostimulation therapy for the many patients who experience persistent pain following back surgery,” said Vincent Galan, MD, DABPM, medical director for Pain Care and PROMISE investigator. “We have offered neurostimulation therapy for seven years as a valuable treatment option for the many patients with back or leg pain who do not receive adequate pain relief from standard therapies, and PROMISE provides the opportunity to assess not only the degree of pain relief this therapy provides but also its impact on key quality of life measures, such as sleep, changes in pain medication and employment status.”
Medtronic neurostimulation therapy (also known as spinal cord stimulation, or SCS) is a widely established treatment option for chronic back and/or leg pain that has been used to treat more than 250,000 people worldwide to date. It uses a medical device to deliver mild electrical impulses to the spinal cord to block pain signals from reaching the brain.
About the PROMISE Study
PROMISE is a prospective, randomized, open-label, parallel-group, clinical study enrolling up to 300 individuals suffering from chronic low back pain due to FBSS at up to 30 centers in the United States, Canada and Europe. It is the first large-scale randomized, controlled clinical trial designed to assess the value of SCS for predominant low back pain using a surgical lead, in contrast to previous studies of this technology, which have focused on predominant leg pain.
PROMISE participants will be randomized 1:1 to receive treatment over a two-year period with either SCS with OMM or OMM only. After a six-month observational phase, the study will compare the proportion of participants in the SCS group who report more than 50 percent reduction in low back pain intensity, as measured by the Numeric Pain Rating Scale, with those in the OMM-only group. Health care utilization data collected will be used to develop cost analysis models for potential use in future studies evaluating the long-term economic impact of SCS with multicolumn surgical leads.
Individuals interested in eligibility and/or enrollment in the PROMISE study at Pain Care should contact Melissa Campbell, NP at (770) 771-6580 or General(at)GeorgiaPainCare(dot)com. For more information about Medtronic neurostimulation therapy, please visit http://www.tamethepain.com.
About Pain Care, LLC
Founded in 2007, Pain Care’s mission is to provide our patients and communities with the highest quality spine care and pain management in a compassionate, caring environment. Our goal is to improve the quality-of-life of our patients through the use of cutting-edge technology and time tested interventional medical techniques. Pain Care is a privately held company and is headquartered in Atlanta, Georgia. Please visit Pain Care online at http://www.georgiapaincare.com!
1 Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research; Consensus Report, Institute of Medicine (IOM), June 2011. Page 1.
2 Hardt J, Jacobsen C, Goldberg J, Nickel R, Buchwald D.: Prevalence of chronic pain in a representative sample in the United States. Pain Medicine 2008; 9:7: 803-812.
3 Chan C, Peng P. Review Article: Failed Back Surgery Syndrome. Pain Medicine 2011; 12: 577-606.