About this trial
Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Major untreated medical comorbidities (uncontrolled diabetes mellitus, severe obesity, uncontrolled cardiopulmonary disease, etc.)
Secondary causes of pelvic pain that can be treated with appropriate medical or surgical interventions
Major untreated psychological comorbidities
Anatomical challeneges to place spinal cord stimulator
Trial design
Single group
Treatments tested in this trial
ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation
DeviceThe patients will receive externalized epidural leads connected to external pulse generator for 5-14 days during trial phase. If the trial results in \>50% reduction in pain, they will undergo a minor surgery to receive implantable spinal cord stimulator
Treatment groups
Trial outcomes
Primary outcomes
Change in Pain Intensity
Numerical Rating Scale (0-10; higher score is worse)
Secondary outcomes
Change in Disability
Pain Disability Index
Patient Global Impression Change
7-point Likert Scale
Change in Quality of Life
Short Form McGill Pain Questionnaire
Change in Pain Catastrophizing Scale
14-item questionnaire scoring 0-52 (higher score worse)
Sponsors and contacts
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