Online Self-Management Program for Chronic Pelvic Pain

Overseen By Jordyn Boggan

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Recent surgery, Pregnancy, Severe impairment, Psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program called My Pelvic Plan Website to determine if it can help people with chronic pelvic pain feel better. The study aims to discover whether this online tool can improve pain levels, physical abilities, and overall quality of life for participants. The trial includes two groups: one uses My Pelvic Plan along with their usual care, and the other uses a symptom monitoring program with their usual care. Individuals who have experienced chronic pelvic pain for at least six months, feel it at least two weeks each month, and receive care at the University of Michigan might be a good fit. As an unphased trial, this study offers a unique opportunity to explore innovative solutions for managing chronic pelvic pain.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this program is safe for managing chronic pelvic pain?

Research has shown that online self-management programs like My Pelvic Plan are generally well-received by users. In a study of a digital program for women's pelvic health, participants experienced less pelvic pain, anxiety, and depression after 4 and 12 weeks. This suggests that using such programs is generally safe.

My Pelvic Plan is an online tool, so it doesn't involve any physical procedures and is unlikely to cause harm. No reports of serious side effects have emerged from its use. The program helps users manage symptoms through education and self-care strategies. Overall, evidence suggests it is a safe option for those with chronic pelvic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about My Pelvic Plan because it offers a fresh approach to managing chronic pelvic pain through an online self-management program. Unlike traditional treatments that often rely on medication or physical therapy, My Pelvic Plan empowers individuals by providing resources and tools to manage their symptoms independently. This online platform is accessible from anywhere, making it a convenient option for those who may have difficulty attending in-person therapy sessions. Additionally, it promotes active participation in one’s own care, which can be empowering and potentially lead to better outcomes.

What evidence suggests that the My Pelvic Plan Website is effective for chronic pelvic pain?

Research has shown that digital self-management programs can help people with chronic pelvic pain (CPP) feel better. One study of a similar online program for women's pelvic health found that it reduced pelvic pain, anxiety, and depression after 4 and 12 weeks. For ongoing issues like CPP, clear guidance on exercise and stress management can be very helpful. In this trial, participants in one arm will access the "My Pelvic Plan" website, which offers lessons on changing thought patterns, using acupressure, and staying active, all aimed at managing CPP. These programs empower users to take control of their pain and improve their quality of life. ^{1 2 3 4 6}

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, which may include conditions like endometriosis. Participants should be seeking new ways to manage their pain and improve their quality of life.

Inclusion Criteria

Access to internet via computer or smartphone

English-language proficiency (current version of the website is in English)

Must be currently receiving care within Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain

Exclusion Criteria

I had surgery related to my reproductive organs within the last 3 months.

Pregnant (self-reported) at time of screening visit. Will not exclude patients that become pregnant during the course of the study

I plan to have gynecologic surgery within the next 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants access the My Pelvic Plan program for self-management of chronic pelvic pain

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• My Pelvic Plan Website

Trial Overview The study compares a standard control group website with the 'My Pelvic Plan' website, designed to help patients self-manage chronic pelvic pain through various strategies aiming at improving pain levels and daily functioning.

How Is the Trial Designed?

Group I: My Pelvic Plan plus usual care Experimental Treatment 1 Intervention

Participants will have access to My Pelvic Plan program.

Group II: Monitoring progress plus usual care Experimental Treatment 1 Intervention

Participants will have access to the monitoring progress web-based symptom monitoring 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 needs assessment involving 23 adolescents with chronic pain revealed significant impacts on their social, emotional, and physical functioning, highlighting the necessity for tailored self-management resources.

The iCanCope with Pain™ program will incorporate features like symptom self-monitoring, personalized goal setting, and peer support to effectively address the unique challenges faced by adolescents transitioning from pediatric to adult care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iCanCope with Pain™: User-centred design of a web- and mobile-based self-management program for youth with chronic pain based on identified health care needs. Stinson, JN., Lalloo, C., Harris, L., et al.[2021]

A review of 27 pain management websites revealed that they generally provide useful self-management strategies, with a median score of 9 out of 14 on the SMS-14 checklist, indicating a moderate level of adherence to best practices.

Top-ranked websites like LivePlanBe, ACI Pain Management Network, and MyJointPain offer valuable resources for self-management, but most lack cultural tailoring and evidence of clinical efficacy, suggesting that users should approach them with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do pain management websites foster self-management support for people with persistent pain? A scoping review. Devan, H., Perry, MA., van Hattem, A., et al.[2022]

A 4-week smartphone intervention that included daily diary entries and therapist feedback significantly reduced catastrophizing in women with chronic widespread pain, showing a large effect size (Cohen's d=0.87) immediately after the intervention.

At a 5-month follow-up, the intervention continued to show moderate effects on reducing catastrophizing, improving pain acceptance, and maintaining functioning levels, indicating its long-term efficacy in supporting self-management after inpatient rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-based intervention with diaries and therapist-feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain: randomized controlled trial. Kristjánsdóttir, OB., Fors, EA., Eide, E., et al.[2022]

A 4-week smartphone intervention following an inpatient chronic pain rehabilitation program showed modest long-term benefits in reducing catastrophizing and increasing acceptance of pain among participants, despite no significant differences between groups at the 11-month follow-up.

While the intervention group experienced improvements in their pain-related thoughts and acceptance, the control group showed negative effects in functioning and emotional distress, highlighting the potential value of ongoing support through digital interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-based intervention with diaries and therapist feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain. part 2: 11-month follow-up results of a randomized trial. Kristjánsdóttir, ÓB., Fors, EA., Eide, E., et al.[2021]

In a study involving 246 participants with chronic pain, the Manage My Pain (MMP) app was associated with lower anxiety levels and reduced pain catastrophizing, indicating its potential effectiveness in managing chronic pain alongside standard care.

Approximately 73.6% of participants agreed to use the app, and those who engaged with it reported significant improvements in mental health outcomes, suggesting that digital tools can enhance patient self-management in chronic pain treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. Bhatia, A., Kara, J., Janmohamed, T., et al.[2021]

Patients with chronic pain reported positive experiences using a combination of psychomotor physiotherapy (PMP) and the eHealth self-management tool EPIO over 10 to 15 weeks, noting increased awareness of their bodily signals and the relationship between pain, stress, and activity.

The blended care approach led to improved self-acceptance and coping strategies, helping patients view their pain as less harmful and engage more actively in managing their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Using an eHealth Pain Management Intervention Combined With Psychomotor Physiotherapy: Qualitative Study. Eiken, AG., Nordanger, DØ., Solberg Nes, L., et al.[2022]

Chronic pain is increasingly recognized as a significant public health issue, necessitating improved management strategies that address its complex nature and impact on patients and communities.

The P.A.I.N. Initiative has been established to enhance pain management quality through workshops for professionals, a software program for documenting patient data, an online discussion forum, and an education program for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pain Associates' International Network Initiative: a novel practical approach to the challenge of chronic pain management in Europe. Morlion, B., Walch, H., Yihune, G., et al.[2011]

Citations

1. mypelvicplan.com mypelvicplan.com/

Homepage | Pelvic Plan Chronic pelvic pain is very common, affecting at least 15-20% of women. We're here to help you make a plan. Learn more

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

Online Self-Management Program for Chronic Pelvic Pain Trial Overview The study compares a standard control group website with the 'My Pelvic Plan' website, designed to help patients self-manage chronic pelvic pain ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04615247

NCT04615247 | Program to Overcome Pelvic Pain Study A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women ... efficacy, and d) Provide Pain Outcomes Data at 8 Weeks. Number of ...

4. 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.

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

Online Education for Chronic Pelvic Pain Trial Overview The study is testing the 'My Pelvic Plan' website, which offers modules on cognitive restructuring, acupressure self-treatment, physical activity ...

6. uofmhealth.org uofmhealth.org/our-care/specialties-services/chronic-pelvic-pain-consultative-clinic

Chronic Pelvic Pain Consultative Clinic Discover expert care for chronic pelvic pain at U-M Women's Health. Learn about our comprehensive treatment options and personalized support.