Evaluating MuscleSCS Device for Treating Chronic Low Back Pain in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a device called MuscleSCS, which uses spinal cord induced muscle stimulation to treat people with chronic low back pain. This prospective, multi-center study focuses on adults with this condition, including those who already have spinal cord stimulation devices and those who are candidates for such treatment. The study aims to better understand how this stimulation affects pain relief and quality of life. Participants will be divided into two groups one group consists of patients who have had a spinal cord stimulation system implanted for more than six months and have experienced significant pain relief the other group includes patients who are candidates for a trial and potential permanent spinal cord stimulation. The study will monitor the use and effects of MuscleSCS over the course of the trial. Throughout the study, participants will be assessed for changes in pain intensity, disability, quality of life, and psychological factors using various measures such as the Numeric Rating Scale NRS, Oswestry Disability Index ODI, EQ5D-5L, Pain Disability Index PDI, Pain Catastrophizing Scale PCS, and Patient Global Impression of Change PGIC. These evaluations will occur from enrollment until three months after study completion, with researchers closely following participants progress and safety.

A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain