The Distinct (dorsal spinal cord stimulation vs. medical management for treatment of low back pain) study seeks to investigate the efficacy of BurstDR SCS compared with conventional medical management (CMM) in people with chronic low back pain that is unmanageable through standard medical care, according to a news release.
Distinct is a prospective, multi-center, randomized, controlled clinical study comparing the SCS system to medication and other non-surgical methods by evaluating improvements in pain, physical function and emotional well-being in the patients who have not had lumbar surgery or for whom surgery is not an option.
Primary and secondary endpoints focus on improvements in physical function and pain relief with additional endpoints slated to be used to evaluate quality of life measures that include depression, sleep, emotional distress, medication usage and overall satisfaction.
The study is set to enroll 270 subjects across up to 30 sites in the U.S. and randomize for SCS treatment and CMM, respectively. Participants will have an option to cross over after six months of treatment in either arm.
“The DISTINCT study will provide important data in our clinical development program for intermittently dosed BurstDR stimulation,” Abbott VP of neuromodulation Keith Boettiger said in the release. “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.”