Medtronic, a healthcare products manufacturer based in Minneapolis, Minnesota, announced that its PROMISE trial (a Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain) has launched. The PROMISE trial will explore the efficacy and safety of the company’s Specify 5-6-5 spinal cord stimulation therapy in patients who have experienced a failed back surgery resulting in recurring low back and leg pain.
According to a press release by the company, the PROMISE trial will comprise 300 patients around the world. The study will compare the Specify SCS system with traditional drug therapy. The trial will be the first of its kind that assesses the efficacy of neurostimulation for the treatment of recurrent low back pain with comorbid leg pain. In the past, similar studies have focused solely on leg pain.
Patients enrolled in the study will be treated at healthcare facilities in the United States, Europe and Canada. Participants will be randomized to receive either drug treatment or drug treatment with the Specify SCS.
Dr. Philippe Rigoard is the global principal investigator at Medtronic. In prepared remarks, he said, "Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study.” He continued, "If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with FBSS.”