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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment My Pelvic Plan Website for chronic pelvic pain?

Research suggests that digital self-management programs, like the My Pelvic Plan Website, can help people manage chronic pain by improving communication with healthcare providers and promoting self-care. Similar programs have shown benefits in managing chronic pain, indicating potential effectiveness for chronic pelvic pain as well. ^{1 2 3 4 5}

How is the My Pelvic Plan Website treatment different from other treatments for chronic pelvic pain?

The My Pelvic Plan Website is unique because it is an online self-management program specifically designed for chronic pelvic pain, offering a convenient and accessible way for patients to manage their condition from home. Unlike traditional treatments that may require in-person visits, this program provides digital tools and resources to help individuals take control of their pain management. ^{2 4 5 6 7}

Research Team

Sara Till, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Using an eHealth Pain Management Intervention Combined With Psychomotor Physiotherapy: Qualitative Study. [2022]

2. Canada 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Pain Associates' International Network Initiative: a novel practical approach to the challenge of chronic pain management in Europe. [2011]

4. United States 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. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Do pain management websites foster self-management support for people with persistent pain? A scoping review. [2022]

6. Canada 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. [2022]

7. Canada 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. [2021]