Online Education for Chronic Pelvic Pain

Overseen By Sara Till, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Severe physical impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how people with chronic pelvic pain (CPP) perceive different treatment options and whether an online program can change these perceptions. The program, called My Pelvic Plan, includes self-guided activities such as cognitive and behavioral strategies, acupressure, and basic pelvic floor exercises. It is designed for individuals who have experienced moderate to severe pelvic pain for at least six months and have pain at least 14 days a month. Participants must be new patients at the University of Michigan's Chronic Pelvic Pain and Endometriosis Referral Clinic and have internet access. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve future treatment options for CPP.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on an educational program rather than medication changes.

What prior data suggests that this web-based educational program is safe for users?

Research shows that the My Pelvic Plan website helps people manage chronic pelvic pain (CPP) through self-guided lessons. These lessons include techniques such as changing thought and behavior patterns, acupressure, exercise, and simple pelvic floor exercises.

Studies have indicated that digital programs for pelvic health, like My Pelvic Plan, are generally easy to use. Most participants reported few or no side effects and noticed improvements in pain, anxiety, and depression over time. The program emphasizes self-management, allowing users to decide how to use it.

The University of Michigan is studying the ease and safety of the My Pelvic Plan website. Although specific results from this study are not yet available, similar programs have shown safety, suggesting that My Pelvic Plan is expected to be safe for managing CPP. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"My Pelvic Plan" is unique because it offers a web-based, self-guided program specifically designed for managing chronic pelvic pain. Unlike traditional treatments such as medications, physical therapy, or surgical interventions, this online platform provides easy access to educational resources and personalized management strategies from the comfort of home. Researchers are excited about its potential to empower patients with knowledge and tools to manage their condition independently, which could lead to improved outcomes and enhanced quality of life without the side effects often associated with conventional treatments.

What evidence suggests that this web-based program is effective for chronic pelvic pain?

Research has shown that online programs can help people manage chronic pelvic pain. One study found that many women want to learn more about their condition, including diagnosis and treatment options. Another study examined a digital program for women's pelvic health and found it reduced pelvic pain, anxiety, and depression after 4 and 12 weeks. These results suggest that using a web-based program like My Pelvic Plan, which participants in this trial will use, could aid in managing chronic pelvic pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Sara Till, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic pelvic pain. Participants should be interested in exploring treatment options and willing to engage with a web-based educational program designed to help manage their condition.

Inclusion Criteria

I have had moderate to severe pelvic pain for at least 6 months.

Access to internet via computer or smartphone

English-language proficiency

Exclusion Criteria

Prior care within the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain (seen previously but meets criteria for new patient visit because > 3 year interval since last clinic visit)

I do not have severe physical impairments that prevent me from using the internet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires and structured interviews to explore prior treatment experiences and perceptions of treatment modalities

1 week

Intervention

Participants engage in a web-based educational and self-management program for chronic pelvic pain, including cognitive and behavioral structuring, self-administration of acupressure, physical activity, and pelvic floor physical therapy techniques

3 weeks

Follow-up

Participants are monitored for changes in treatment perceptions and interest in treatment modalities

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• My Pelvic Plan website

Trial Overview The study is testing the 'My Pelvic Plan' website, which offers modules on cognitive restructuring, acupressure self-treatment, physical activity encouragement, and an introduction to pelvic floor physical therapy techniques.

How Is the Trial Designed?

Group I: My Pelvic Plan Experimental Treatment 1 Intervention

This is a web-based self-guided program.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A survey of 136 women with chronic pelvic pain revealed that they are most interested in learning about diagnosis, treatment, coping strategies, and diet/exercise related to their condition, indicating a strong need for targeted educational resources.

After participating in a webinar designed to address these educational needs, patients reported a significant reduction in pain-related interference, suggesting that such educational programs can effectively empower patients to manage their symptoms better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responding flexibly to the complex problem of chronic pelvic pain: Incorporating patient needs into program development. Kreher, DA., Gubbels, AL., Eastin, S., et al.[2023]

Citations

1. mypelvicplan.com mypelvicplan.com/

Homepage | Pelvic Plan Introduces some management strategies that are likely to be beneficial for most people with chronic pelvic pain, regardless of the individual pain contributors.

2. withpower.com withpower.com/trial/phase-chronic-pelvic-pain-9-2024-9a25e

Online Education for Chronic Pelvic Pain A survey of 136 women with chronic pelvic pain revealed that they are most interested in learning about diagnosis, treatment, coping strategies, and diet/ ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10822071/

Empowered management for pelvic pain - PubMed Central This study aims to understand the experience of women with persistent pelvic pain participating in an online, self-management education program.

4. withpower.com withpower.com/trial/online-self-management-program-for-chronic-pelvic-pain-8bb8f

Online Self-Management Program for Chronic Pelvic Pain The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).

5. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03475-4

Clinical outcomes of a digital musculoskeletal women's pelvic ... This longitudinal, observational study of a digital women's pelvic health program examined pelvic pain, anxiety, and depression at 4 and 12 weeks.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11724504/

Clinical outcomes of a digital musculoskeletal women's ... This longitudinal, observational study of a digital women's pelvic health program examined pelvic pain, anxiety, and depression at 4 and 12 weeks.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04615247

NCT04615247 | Program to Overcome Pelvic Pain Study Women aged 18 years or older who report chronic or recurrent pelvic pain for at least 6 months. Report an average daily pain intensity score of at least 4 (on ...

8. uroweb.org uroweb.org/guidelines/chronic-pelvic-pain/chapter/management

EAU Guidelines on Chronic Pelvic Pain - MANAGEMENT This guideline plays an important role in the process of consolidation and improvement of care for patients with abdominal and pelvic pain.