Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome

The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.

After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.

Inclusion Criteria:

• 18 years or older
• neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
• pre-procedure psychological clearance

Exclusion Criteria:

• younger than 18 years
• prior neuromodulation including spinal cord stimulation
• prior dorsal root ganglion stimulation
• prior peripheral nervous system stimulation
• anatomical obstacles to dorsal column lead placement