Evaluating Intermittent Dosing of Dorsal Root Ganglion Stimulation at 20 Hz and 5 Hz Compared to Continuous Therapy for Chronic Pain Relief in Adults

What this Trial Is About

Researchers are evaluating intermittent dosing as a new approach for patients who have had dorsal root ganglion DRG stimulation for at least one year with at least 50% pain relief in the treated area. The study aims to compare two different intermittent dosing patterns to see if they provide better pain relief than continuous DRG stimulation. This research focuses on chronic pain conditions like complex regional pain syndrome CRPS and other neuropathic pain disorders, exploring stimulation frequencies that might improve long-term pain control. Participants will be randomly assigned to one of two groups one receiving DRG stimulation at 20 Hz and the other at 5 Hz, both cycling 30 seconds ON and 90 seconds OFF to stay within a therapeutic range. After 13 weeks, patients will switch to the other stimulation frequency in a crossover design. Evaluations occur before treatment, and then at 4, 8, 12 weeks, followed by a 1-week washout of continuous stimulation, and after crossover at 17, 21, and 25 weeks. During the study, participants will undergo regular assessments including pain scores, questionnaires about physical function, emotional distress, sleep, and overall well-being. Device settings and usage patterns will be monitored, and X-rays will confirm DRG lead positioning. Safety and patient satisfaction will be tracked throughout the six-month study period. Participants can return to their preferred stimulation if pain relief diminishes, ensuring ongoing care.

Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy