Chronic Pelvic Pain SyndromeNCT06377969
Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
A study of Chronic Pelvic Pain Syndrome, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford
Redwood City, California, 94063
Vafi Salmasi, MD, 650-725-0246, vsalmasi@stanford.edu
About this study
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.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord StimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Patient will go through trial of spinal cord stimulator. If trial results in >50% reduction in pain, they will receive implantable spinal cord stimulator Receives: Device: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Numerical Rating Scale (0-10; higher score is worse)
Measured: Baseline, 3-month, 6-month and 12-month
Secondary outcomes (6)
Change in Disability
Pain Disability Index
Measured: Baseline, 3-month, 6-month and 12-month
Patient Global Impression Change
7-point Likert Scale
Measured: Baseline, 3-month, 6-month and 12-month
Change in Quality of Life
Short Form McGill Pain Questionnaire
Measured: Baseline, 3-month, 6-month and 12-month
Change in Pain Catastrophizing Scale
14-item questionnaire scoring 0-52 (higher score worse)
Measured: Baseline, 3-month, 6-month and 12-month
Change in sleep quality
PROMIS (Patient Reported Outcomes Measure Information System) Sleep Disturbance (t-score and percentile)
Measured: Baseline, 3-month, 6-month and 12-month
Change in Social Functioning
PROMIS Satisfaction with social roles and activities (t-score and percentile)
Measured: Baseline, 3-month, 6-month and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 Jun 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot prospective single arm interventional study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vafi Salmasi, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377969
- Sponsor's protocol ID
- 75269
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT06377969
- Acronym / sponsor ID
- 75269
- Conditions
- Chronic Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot prospective single arm interventional study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord StimulationPatient will go through trial of spinal cord stimulator. If trial results in >50% reduction in pain, they will receive implantable spinal cord stimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord StimulationThe 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 | Device | Treatment |
Primary outcome
Change in Pain Intensity
Time frame: Baseline, 3-month, 6-month and 12-month
Numerical Rating Scale (0-10; higher score is worse)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Pelvic Pain Syndrome
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
Not yet recruiting
Pregabalin for Chronic Pelvic Pain in Women
Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Chronic Pelvic Pain Syndrome, Pelvic Pain
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Pelvic Pain Syndrome, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vafi Salmasi, MD (6507250246, vsalmasi@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline, 3-month, 6-month and 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.