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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The 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
Stanford
Redwood City, California, United States
RECRUITINGChange in Pain Intensity
Numerical Rating Scale (0-10; higher score is worse)
Time frame: Baseline, 3-month, 6-month and 12-month
Change in Disability
Pain Disability Index
Time frame: Baseline, 3-month, 6-month and 12-month
Patient Global Impression Change
7-point Likert Scale
Time frame: Baseline, 3-month, 6-month and 12-month
Change in Quality of Life
Short Form McGill Pain Questionnaire
Time frame: Baseline, 3-month, 6-month and 12-month
Change in Pain Catastrophizing Scale
14-item questionnaire scoring 0-52 (higher score worse)
Time frame: Baseline, 3-month, 6-month and 12-month
Change in sleep quality
PROMIS (Patient Reported Outcomes Measure Information System) Sleep Disturbance (t-score and percentile)
Time frame: Baseline, 3-month, 6-month and 12-month
Change in Social Functioning
PROMIS Satisfaction with social roles and activities (t-score and percentile)
Time frame: Baseline, 3-month, 6-month and 12-month
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