Online Program for Endometriosis Pain

Overseen By Caroline Pukall, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dr. Caroline Pukall

Disqualifiers: Under 18, Non-English speakers, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test an online program called PelvicSense designed to help people with endometriosis manage their pain. Participants will follow the program remotely and continue their usual treatments. The study aims to see if this program can improve pain and other health outcomes.

Do I have to stop taking my current medications for the trial?

No, you do not have to stop taking your current medications. Participants are expected to continue their usual treatment during the study.

How is the PelvicSense(R) treatment for endometriosis pain different from other treatments?

PelvicSense(R) is unique because it is an online program that uses digital tools to deliver exercise interventions for managing endometriosis pain, offering a non-drug alternative that can be accessed remotely, which may improve adherence and accessibility compared to traditional face-to-face exercise programs. ^{1 2 3 4 5}

Research Team

Caroline Pukall, PhD

Principal Investigator

Queen's University

Eligibility Criteria

This trial is for adults over 18 who speak English and have been diagnosed with endometriosis, experiencing pain for at least three months. Participants will continue their usual treatment while being involved in the study.

Inclusion Criteria

I am over 18, speak English, and have been diagnosed with endometriosis for at least 3 months.

Exclusion Criteria

I am not fluent in English.

Self-identified diagnosis

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the PelvicSense 3-month online program focusing on pain management and sexual outcomes

12 weeks

Remote participation via online, email, and video calls

Follow-up

Participants are monitored for pain and sexual outcomes 3 months after the end of the program

3 months

Remote assessments

Treatment Details

Interventions

• PelvicSense(R)

Trial Overview The PelvicSense online program's effectiveness on reducing pain and improving sexual outcomes in individuals with endometriosis is being tested. The study spans over a period of six months including assessments before, after the 3-month program, and a follow-up.

Participant Groups

Group I: 3 month PelvicSense(R) program Experimental Treatment 1 Intervention

PelvicSense® is a home-based physiotherapy program integrating multiple techniques, including relaxation, breathing, stretching, strengthening and at-home manual therapy. This program also educates participants about the anatomy and physiology of the pelvis and teaches strategies to strengthen the mind-muscle connection to the pelvis.

Who Is Running the Clinical Trial?

Dr. Caroline Pukall

Lead Sponsor

Trials

3

Recruited

130+

Dr. Caroline Pukall

Lead Sponsor

Trials

3

Recruited

130+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Findings from Research

A study involving 22 women with endometriosis found that both telehealth-delivered exercise and virtual reality (VR)-delivered exercise showed potential for immediate pain relief, although no significant differences were observed between the two methods.

While neither exercise method resulted in statistically significant pain reduction compared to a control group, both telehealth and VR exercises demonstrated a more favorable change in pain scores, suggesting they may be effective non-pharmacological options for managing pelvic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single Session of a Digital Health Tool-Delivered Exercise Intervention May Provide Immediate Relief from Pelvic Pain in Women with Endometriosis: A Pilot Randomized Controlled Study. Lutfi, M., Dalleck, LC., Drummond, C., et al.[2023]

Endometriosis affects about 10% of women of reproductive age and is characterized by chronic pelvic pain, which significantly impacts quality of life; however, the severity of pain does not always correlate with the stage of the disease.

The pain associated with endometriosis is linked to complex mechanisms, including central sensitization, peripheral nociceptive pathway activation, and immune system dysfunction, particularly in cases of deep endometriosis, highlighting the need for targeted treatments based on these insights.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A deep insight into pelvic pain and endometriosis: a review of the literature from pathophysiology to clinical expressions. Masciullo, L., Viscardi, MF., Piacenti, I., et al.[2021]

The 'Sex, Pain, and Endometriosis' website was found to be user-friendly and effective in providing evidence-based information about endometriosis and sexual pain, helping to empower users and reduce stigma around the condition.

While the website had minor usability issues, it was generally perceived as nonstigmatizing, and participants provided valuable feedback for improving website design to enhance privacy and inclusiveness for users seeking sensitive health information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an Educational Website for Women With Endometriosis-Associated Dyspareunia: Usability and Stigma Analysis. Abdulai, AF., Howard, AF., Yong, PJ., et al.[2022]

In a study of 56 patients aged 15-35 with endometriosis, dienogest (2 mg daily) provided significant pain relief, with 67.8% of patients reporting relief within 2-5 days and 73.2% experiencing over 30% pain reduction after 3 months.

While dienogest was well tolerated and prevented the growth of endometriomas, significant reduction in cyst size was rare, with only 12.5% of patients showing more than 50% regression after 3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Dienogest in Endometriosis in Young Women. Malik, R., Mann, MK.[2022]

In a retrospective study of 618 patients with endometriosis, pelvic pain was found to not accurately reflect the stage and severity of the disease in 40% of cases.

Some patients with advanced stage IV endometriosis experienced less pain than those with earlier stages (I or II), indicating that the current classification system does not effectively assess the severity of pelvic pain associated with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is pelvic endometriosis always associated with chronic pain? A retrospective study of 618 cases diagnosed by laparoscopy. Fukaya, T., Hoshiai, H., Yajima, A.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Single Session of a Digital Health Tool-Delivered Exercise Intervention May Provide Immediate Relief from Pelvic Pain in Women with Endometriosis: A Pilot Randomized Controlled Study. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

A deep insight into pelvic pain and endometriosis: a review of the literature from pathophysiology to clinical expressions. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Developing an Educational Website for Women With Endometriosis-Associated Dyspareunia: Usability and Stigma Analysis. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Role of Dienogest in Endometriosis in Young Women. [2022]

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

Is pelvic endometriosis always associated with chronic pain? A retrospective study of 618 cases diagnosed by laparoscopy. [2019]