Reasons for screening failure(s) will be documented. Patients must meet all inclusion/exclusion criteria for enrollment in the clinical study. A Screening/Enrollment Log will be utilized in order to maintain a cumulative tracking of all screened patients. The total study duration is expected to be at least 30 months.Īll patients presenting to the Investigators with Budapest criteria, research subset, for the diagnosis of Complex Regional Pain Syndrome at an infraumbilical location who have not had an adequate response to a course of conservative management including analgesics and physical therapy will be screened for eligibility. Clinical follow-up evaluations will be conducted at 10 days, 1, 3 and 6 months post-implant. The study will be conducted a single center with a target maximum of 62 patients (31 randomized to each group).Įnrollment of subjects in this study is anticipated to take 24 months. All patients are expected to undergo clinical, neurological, and imaging assessments, if appropriate, at selected follow-up visits. Patients will be randomized in a 1:1 ratio to Dorsal Column or Dorsal Root Ganglion Spinal Cord Stimulation if they have failed a course of conservative management including analgesics and physical therapy. This is a prospective randomized post-marketing clinical study. The purpose of this study is to compare outcomes between dorsal column spinal cord stimulation and dorsal root ganglion spinal cord stimulation in patients with Complex Regional Pain Syndrome at an infraumbilical location who have failed a course of conservative management including analgesic pharmacotherapy and physical therapy. The aim to assess functional, quality of life, patient satisfaction and medication requirements in subjects treated with neuromodulation for CRPS and contrast outcomes amongst subjects treated with DRG SCS and dorsal column SCS. The hypothesis is that DRG stimulation is non-inferior to dorsal column SCS in patients with CRPS who have failed to respond to a course of analgesics and physical therapy. Dorsal Root Ganglion (DRG) SCS has also recently demonstrated clinical efficacy in patients with CRPS and peripheral causalgia. 40%-50% of CRPS patients achieve >50% pain relief with SCS using dorsal column stimulation. Treatment of CRPS with SCS, in combination with physical therapy, reduced pain to a greater degree than physical therapy alone. ![]() ![]() Spinal Cord Stimulation (SCS), a technique of placing electrodes into the epidural space is a validated treatment for Complex Regional Pain Syndrome. SCS disrupts pain signals traveling between the spinal. Complex Regional Pain Syndrome (CRPS) is a constellation of pain symptoms which are associated with impairment in mood, social and physical function. Spinal cord stimulation (SCS) is a proven long-term and effective therapy for managing chronic pain.
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