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NCT Number: NCT06377969

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.

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Key information

Conditions

Chronic Pelvic Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford

Redwood City, California, 94063, United States

Location status: Recruiting

Location contact

Vafi Salmasi, MD

CONTACT

[email protected]

650-725-0246

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in Pain Intensity

    Time frame: Baseline, 3-month, 6-month and 12-month

    Numerical Rating Scale (0-10; higher score is worse)

Secondary outcomes

  1. Change in Disability

    Time frame: Baseline, 3-month, 6-month and 12-month

    Pain Disability Index

  2. Patient Global Impression Change

    Time frame: Baseline, 3-month, 6-month and 12-month

    7-point Likert Scale

  3. Change in Quality of Life

    Time frame: Baseline, 3-month, 6-month and 12-month

    Short Form McGill Pain Questionnaire

  4. Change in Pain Catastrophizing Scale

    Time frame: Baseline, 3-month, 6-month and 12-month

    14-item questionnaire scoring 0-52 (higher score worse)

  5. Change in sleep quality

    Time frame: Baseline, 3-month, 6-month and 12-month

    PROMIS (Patient Reported Outcomes Measure Information System) Sleep Disturbance (t-score and percentile)

  6. Change in Social Functioning

    Time frame: Baseline, 3-month, 6-month and 12-month

    PROMIS Satisfaction with social roles and activities (t-score and percentile)

Study contacts

Contact information is provided by the study sponsor or research team.

Vafi Salmasi, MD

CONTACT

[email protected]

6507250246

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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