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

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 Overview

• Status: Recruiting
• Conditions: Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Device: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vafi Salmasi, MD; Phone Number: 6507250246; Email: vsalmasi@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford
      • Contact: Vafi Salmasi, MD; Phone Number: 650-725-0246; Email: vsalmasi@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: ECAP (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: 75269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No