Chronic Pelvic Pain Syndrome
Conditions
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.
Interventions
DEVICEECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation
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
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot prospective single arm interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | Baseline, 3-month, 6-month and 12-month | Numerical Rating Scale (0-10; higher score is worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability | Baseline, 3-month, 6-month and 12-month | Pain Disability Index |
| Patient Global Impression Change | Baseline, 3-month, 6-month and 12-month | 7-point Likert Scale |
| Change in Quality of Life | Baseline, 3-month, 6-month and 12-month | Short Form McGill Pain Questionnaire |
| Change in Pain Catastrophizing Scale | Baseline, 3-month, 6-month and 12-month | 14-item questionnaire scoring 0-52 (higher score worse) |
| Change in sleep quality | Baseline, 3-month, 6-month and 12-month | PROMIS (Patient Reported Outcomes Measure Information System) Sleep Disturbance (t-score and percentile) |
| Change in Social Functioning | Baseline, 3-month, 6-month and 12-month | PROMIS Satisfaction with social roles and activities (t-score and percentile) |
Countries
United States
Contacts
CONTACTVafi Salmasi, MD
Outcome results
None listed