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

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377969
• Other study ID #: 75269
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Vafi Salmasi, MD
• Phone: 6507250246
• Email: vsalmasi[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity	Numerical Rating Scale (0-10; higher score is worse)	Baseline, 3-month, 6-month and 12-month
Secondary	Change in Disability	Pain Disability Index	Baseline, 3-month, 6-month and 12-month
Secondary	Patient Global Impression Change	7-point Likert Scale	Baseline, 3-month, 6-month and 12-month
Secondary	Change in Quality of Life	Short Form McGill Pain Questionnaire	Baseline, 3-month, 6-month and 12-month
Secondary	Change in Pain Catastrophizing Scale	14-item questionnaire scoring 0-52 (higher score worse)	Baseline, 3-month, 6-month and 12-month
Secondary	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
Secondary	Change in Social Functioning	PROMIS Satisfaction with social roles and activities (t-score and percentile)	Baseline, 3-month, 6-month and 12-month