Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation

Evaluation of Physiological Parameters in Patients With Complex Regional Pain Syndrome of the Lower Limbs Treated With Dorsal Root Ganglion Stimulation.

1. Objective and Rationale: The study seeks to evaluate how Dorsal Root Ganglion Stimulation (DRGS) influences autonomic functions in patients suffering from Complex Regional Pain Syndrome type I (CRPS I), offering new metrics beyond pain scores to assess therapeutic efficacy.
2. Innovative Approach: Continuous monitoring of patients using validated, CE-marked biosensors (Corsano Biosensor and Motionwatch8) to collect real-time physiological data during active DRGS therapy and therapy cessation periods.
3. Clinical Impact: Results from this study may improve patient management strategies and refine treatment protocols for individuals living with CRPS I.

Inclusion Criteria:

• Patients diagnosed with Complex Regional Pain Syndrome Type I (CRPS I) of the lower limbs.
• Currently treated with Dorsal Root Ganglion Stimulation (DRGS).
• Patients must experience > 50% pain relief with DRGS therapy for at least three months.
• Willingness and ability to comply with the study requirements, including wearing biosensors, and sharing their physiological parameters.

Exclusion Criteria:

• Refusal or inability to wear biosensor wearables.
• Current pregnancy.
• Patients with other significant medical conditions that could affect autonomic function.
• Known allergies or intolerance to materials used in biosensors.
• Diagnosis of untreated Obstructive Sleep Apnea Syndrome (OSAS).
• Ongoing psychiatric disorders