Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Patient will go through trial of spinal cord stimulator. If trial results in >50% reduction in pain, they will receive implantable spinal cord stimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity | Numerical Rating Scale (0-10; higher score is worse) | Baseline, 3-month, 6-month and 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disability | Pain Disability Index | Baseline, 3-month, 6-month and 12-month |
| Patient Global Impression Change | 7-point Likert Scale |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vafi Salmasi, MD | Contact | 6507250246 | vsalmasi@stanford.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Recruiting | Redwood City | California | 94063 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pilot prospective single arm interventional study
Not provided
Not provided
Not provided
Not provided
|
| Baseline, 3-month, 6-month and 12-month |
| Change in Quality of Life | Short Form McGill Pain Questionnaire | Baseline, 3-month, 6-month and 12-month |
| Change in Pain Catastrophizing Scale | 14-item questionnaire scoring 0-52 (higher score worse) | 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) | Baseline, 3-month, 6-month and 12-month |
| Change in Social Functioning | PROMIS Satisfaction with social roles and activities (t-score and percentile) | Baseline, 3-month, 6-month and 12-month |