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Recruiting NCT06377969

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

No phase Interventional Chronic Pelvic Pain Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation.
Who it may be relevant to
Registry conditions: Chronic Pelvic Pain Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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

Primary outcome measures

  • Change in Pain Intensity [Time frame: Baseline, 3-month, 6-month and 12-month]
Secondary outcome measures (6)
  • Change in Disability [Time frame: Baseline, 3-month, 6-month and 12-month]
  • Patient Global Impression Change [Time frame: Baseline, 3-month, 6-month and 12-month]
  • Change in Quality of Life [Time frame: Baseline, 3-month, 6-month and 12-month]
  • Change in Pain Catastrophizing Scale [Time frame: Baseline, 3-month, 6-month and 12-month]
  • Change in sleep quality [Time frame: Baseline, 3-month, 6-month and 12-month]
  • Change in Social Functioning [Time frame: Baseline, 3-month, 6-month and 12-month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford — Redwood City

Identifiers

NCT: NCT06377969 · 75269

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗