Chronic Pelvic PainNCT06352840
Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain
A study testing My Pelvic Plan Website in people with Chronic Pelvic Pain and Endometriosis, run by University of Michigan at 1 site in United States.
Trial summary
The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP). The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pelvic Pain, Endometriosis
- What is being tested?
- My Pelvic Plan Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2024to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
- Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain
- Access to internet via computer or smartphone
- English-language proficiency (current version of the website is in English)
Who cannot join
- Underwent gynecologic surgery within 3 months of screening visit
- Plan to undergo gynecologic surgery within 6 months following screening visit
- Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study.
- Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
- Current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder),
- Current suicidal ideation or suicide attempt within 2 years of screening visit. The study will screen for severe depression and suicidality at each questionnaire time point and have developed a robust triage and referral plan.
Trial locations and contacts
1 site in 1 country.
About this study
The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).
The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.
- Conditions
- Chronic Pelvic Pain, Endometriosis
- Being tested
- My Pelvic Plan Website, Control Group website
- Keywords
- Quality of life, Cognitive Behavioral Therapy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Pelvic Plan WebsiteBehavioural
This is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase.
Control Group websiteBehavioural
Patients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity).
| Study group | Role | What they receive |
|---|---|---|
| Monitoring progress plus usual care | Other | Participants will have access to the monitoring progress web-based symptom monitoring program. Receives: Behavioral: Control Group website |
| My Pelvic Plan plus usual care | Experimental | Participants will have access to My Pelvic Plan program. Receives: Behavioral: My Pelvic Plan Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
Measured: 3 months
PROMIS Pain Intensity 1a Between Groups
There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.
Measured: 3 months
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.
Measured: 3 months
Secondary outcomes (3)
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
Measured: 6 months
PROMIS Pain Intensity 1a Between Groups
There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.
Measured: 6 months
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start20 Jun 2024
- Primary completion23 Jan 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sara Till, MD, MPH, University of Michigan
- Investigators
- Sara Till, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352840
- Sponsor's protocol ID
- HUM00231526
- Other IDs
- 5K23HD099283-03
- Status last verified
- Jan 2026
- First submitted
- 2 Apr 2024
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT06352840
- Acronym / sponsor ID
- HUM00231526
- Conditions
- Chronic Pelvic Pain, Endometriosis
- Keywords
- Quality of life, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Posted 13 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).
The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring progress plus usual care | Other | Behavioral: Control Group websiteParticipants will have access to the monitoring progress web-based symptom monitoring program. |
| My Pelvic Plan plus usual care | Experimental | Behavioral: My Pelvic Plan WebsiteParticipants will have access to My Pelvic Plan program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants have chronic pelvic pain, defined by the protocol for ≥ 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
- Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain
- Access to internet via computer or smartphone
- English-language proficiency (current version of the website is in English)
Key exclusion criteria (6 listed)
- Underwent gynecologic surgery within 3 months of screening visit
- Plan to undergo gynecologic surgery within 6 months following screening visit
- Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study.
- Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
- Current psychiatric disorder with history of psychosis (for example, schizophrenia, schizoaffective disorder, delusional disorder),
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 |
|---|---|---|
| My Pelvic Plan WebsiteThis is a self-directed program which integrates patient education about conditions that frequently contribute to pelvic pain, as well as instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Participants will have open access to the program over the 6-month intervention period. The intervention will be comprised of an active (12-week) phase and a maintenance (3-month) phase. Participants will receive a weekly text or email prompt directing patients to a specific module. All participants will receive prompts to the same modules for the first four weeks of the study, then during the next 8 weeks, participants will receive prompts to modules that corresponded to the most impactful symptoms on participant's baseline questionnaires. Following 12-week active phase, all participants will enter the maintenance phase. | Behavioural | My Pelvic Plan plus usual care |
| Control Group websitePatients in the control group will undergo an active control intervention in which participants receive open access to a separate website that contains only the Monitoring Progress symptom tracker subpage over the 6-month study period. Control group participation will also be divided into an active (12-week) phase and a maintenance (3-month) phase. Similar to the intervention group, the control group will receive a weekly text (first 12 weeks) or email prompt directing them to a specific module or portion of the respective website. During the maintenance phase of the study, participants will receive monthly prompts to the Monitoring Progress subpage (without prompting to a specific symptom or activity). | Behavioural | Monitoring progress plus usual care |
Primary outcome
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
Time frame: 3 months
There are four questions that participants will answer from not at all (1) - very much (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more interference and lower scores below 50 meaning less interference.
PROMIS Pain Intensity 1a Between Groups
Time frame: 3 months
There is one question that participants will answer no pain (0) - worst pain (10). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning higher pain intensity and lower scores below 50 meaning lower pain intensity.
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
Time frame: 3 months
There are four questions that participants will answer from I am not all confident (1) - I am very confident (5). The raw data was then converted to a t-score based on a population mean of 50 and standard deviation of 10, with higher scores above 50 meaning more confidence in managing symptoms and lower scores below 50 meaning less confidence.
3 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups
Time frame: 6 months
PROMIS Pain Intensity 1a Between Groups
Time frame: 6 months
PROMIS Self Efficacy for Managing Symptoms SF 4a Between Groups
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
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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. This study is not recruiting at the moment.
Sara Till, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Pelvic Plan Website in people with Chronic Pelvic Pain and Endometriosis, run by University of Michigan 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Feb 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?
Yes. Results are posted in the registry (first posted 13 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF) 4a Between Groups (time frame: 3 months). The study lists 3 primary outcomes in all. 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 13 Feb 2026.