Abbott Begins Study of BurstDR Stimulation for Non-Operative Low Back Pain

The first patient has been enrolled in Abbott’s DISTINCT study (Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain). The study will investigate the efficacy of the company’s BurstDR spinal cord stimulation (SCS) compared with conventional medical management (CMM) in people with chronic low back pain that cannot be managed with standard medical care. The study will evaluate improvement in pain, physical function and emotional well-being in people living with chronic low back pain, who have not had lumbar spine surgery or for whom surgery is not an option.
 
It is estimated that more than 30 million Americans experience low back pain at any given time, and low back pain is one of the most common reasons people see a doctor.¹ Low back pain may range in intensity from a constant ache to a sharp or shooting pain.²
 
“Unlike other spinal conditions, there is a lack of clear treatment guidelines for people living with severe low back pain who are ineligible for back surgery and are unresponsive to traditional medical treatments and rehabilitation methods. The lack of evidence-based guidelines leads to an imbalance of care for this specific subset of patients,” said James J. Yue, M.D., Associate Clinical Professor in the Department of Surgery, Frank H. Netter School of Medicine, Quinnipiac University, Conn., and co-principal investigator of the trial. “These patients need more treatment alternatives, and we look forward to researching BurstDR as an important therapeutic option in lower back pain treatment.”
 
DISTINCT is a prospective, multi-center, randomized, controlled clinical study designed to evaluate the efficacy of Abbott’s BurstDR SCS in the treatment of chronic low back pain with a neuropathic (unrelenting, severe and constant pain) component, compared to conventional medical management—using medication and other non-surgical methods to treat the patient’s pain.
 
Primary and secondary endpoints of the study will capture participant’s improvement in physical function and pain relief. Additional endpoints will be used to evaluate quality of life measures including depression, sleep, emotional distress, medication usage and overall participant satisfaction with the therapy. The DISTINCT study will enroll 270 subjects at up to 30 sites in the United States and then randomize for SCS treatment and CMM, respectively. Following six months of treatment in either arm, all participants will have an option to cross over—presenting an opportunity for those in the medical management arm of the study to opt for BurstDR stimulation in the open label part of the study.
 
“The DISTINCT study will provide important data in our clinical development program for intermittently dosed BurstDR stimulation,” said Keith Boettiger, vice president, Neuromodulation, Abbott. “Conducting this study is another example of how Abbott is listening to patients, physicians and the pain community to address current unmet needs in pain management. For the patients, we see this as a unique opportunity to address their suffering as well as their pain.”
 
References
¹ Jensen M, Brant-Zawadzki M, Obuchowski N, et al. Magnetic Resonance Imaging of the Lumbar Spine in People Without Back Pain. N Engl J Med 1994; 331: 69-116.
² National Institute of Health. “Back Pain Fact Sheet”, NINDS, Publication date March 2020. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Low-Back-Pain-Fact-Sheet