Effectiveness of Closed-Loop Spinal Cord Stimulation for Treating Complex Regional Pain Syndrome in Early and Chronic Phases

What this Trial Is About

Researchers are evaluating how a closed-loop spinal cord stimulator works to treat complex regional pain syndrome CRPS, comparing its effects when applied early in the acute or subacute phases versus the chronic phase. This study aims to understand differences in treatment responses to improve management of CRPS, a condition characterized by persistent pain and nervous system changes. It is an interventional trial led by Scripps Health focusing on this specialized device. Participants diagnosed with either acute or subacute CRPS will be assigned to one group, while those with chronic CRPS will be assigned to another. All participants will undergo a 7-day trial period using a temporary spinal cord stimulator. If the device improves pain and function during this trial, a permanent device will be implanted. The closed-loop system adjusts stimulation based on real-time physiological responses to address inflammation and nerve dysfunction associated with CRPS. During the study, participants will complete outcome questionnaires at baseline, after the trial, and at 3 and 6 months. Blood samples will be taken to measure prolactin levels related to stress and pain at baseline, after the trial, and at 3 months. Researchers will assess changes in CRPS severity, stimulation device parameters, pain levels, quality of life, anxiety, depression, and medication use. The total participation includes these follow-up periods to monitor treatment impact and safety.

Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome