Low back pain is the world's leading cause of years lost to disability.1 Often, there is not a specific anatomical cause that can be treated with spine surgery.
Neurostimulation is a well-established pain treatment used by doctors for more than 50 years. One of Abbott's most advanced forms of this therapy is BurstDR™ stimulation. It works by using mild electrical pulses delivered by a small implant to change pain signals as they travel from the spinal cord to the brain.2
The DISTINCT study is designed to understand how BurstDR stimulation can relieve pain and improve physical function in people with chronic low back pain who have not had back surgery and in people who are not good candidates for surgery.
When you participate in a clinical trial, you are joining the front line against a disease. If you have suffered with low back pain for more than 6 months and have been told you are not a candidate for spine surgery, ask your doctor if the DISTINCT study is right for you.
DISTINCT will evaluate the efficacy of spinal cord stimulation to relieve pain and improve physical function in people with chronic low back pain who have not had back surgery and for whom other treatments, such as medication, physical therapy and injections, have failed. This study will randomize participants to either conventional medical management or spinal cord stimulation for 6 months. After 6 months, participants may cross over to the treatment arm of the study.
In order to qualify for the study, your answers to the following must be YES:
And your answers to all of the following must be NO:
1. Buchbinder R, van Tulder M, Oberg B, et al. Low back pain: a call for action. Lancet. 20i8;39i(i0i37):2384-2388.
2. De Ridder, D., Vanneste, S., Plazier, M., & Vancamp, T., (2015). Mimicking the Brain: Evaluation of St. Jude Medical's Prodigy Chronic Pain System with Burst Technology. Expert Review of Medical Devices, 12(2), 143-150
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.