Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Pelvic Pain Syndrome
• Interventions: Device: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation

• Registration Number: NCT06377969
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Study Start: 2025-03-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation	Patient will go through trial of spinal cord stimulator. If trial results in \>50% reduction in pain, they will receive implantable spinal cord stimulator

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity	Baseline, 3-month, 6-month and 12-month	Numerical Rating Scale (0-10; higher score is worse)

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression Change	Baseline, 3-month, 6-month and 12-month	7-point Likert Scale
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 Disability	Baseline, 3-month, 6-month and 12-month	Pain Disability Index
Change in Quality of Life	Baseline, 3-month, 6-month and 12-month	Short Form McGill Pain Questionnaire
Change in Social Functioning	Baseline, 3-month, 6-month and 12-month	PROMIS Satisfaction with social roles and activities (t-score and percentile)