Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
Overview
- Phase
- N/A
- Intervention
- ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation
- Conditions
- Chronic Pelvic Pain Syndrome
- Sponsor
- Stanford University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in Pain Intensity
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
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.
Investigators
Vafi Salmasi
Assistant Professor
Stanford University
Eligibility Criteria
Inclusion Criteria
- •The investigators will include all adult patients (18 or older) with pelvic pain more than 6 months that has not responded to conservative medical management
Exclusion Criteria
- •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
- •Ongoing legal or disability claims
Arms & Interventions
Treatment
Patient will go through trial of spinal cord stimulator. If trial results in \>50% reduction in pain, they will receive implantable spinal cord stimulator
Intervention: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation
Outcomes
Primary Outcomes
Change in Pain Intensity
Time Frame: Baseline, 3-month, 6-month and 12-month
Numerical Rating Scale (0-10; higher score is worse)
Secondary Outcomes
- Patient Global Impression Change(Baseline, 3-month, 6-month and 12-month)
- Change in Pain Catastrophizing Scale(Baseline, 3-month, 6-month and 12-month)
- Change in sleep quality(Baseline, 3-month, 6-month and 12-month)
- Change in Disability(Baseline, 3-month, 6-month and 12-month)
- Change in Quality of Life(Baseline, 3-month, 6-month and 12-month)
- Change in Social Functioning(Baseline, 3-month, 6-month and 12-month)