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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06377969
Other study ID # 75269
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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