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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: TreatmentOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pain Intensity

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

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

Secondary outcomes

1

Change in Disability

Pain Disability Index

Time frame
Baseline, 3-month, 6-month and 12-month
2

Patient Global Impression Change

7-point Likert Scale

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

Change in Quality of Life

Short Form McGill Pain Questionnaire

Time frame
Baseline, 3-month, 6-month and 12-month
4

Change in Pain Catastrophizing Scale

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

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

Other outcomes

Sponsors and contacts

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