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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program called PelvicSense to determine its effectiveness in reducing pain for people with endometriosis. The program includes techniques such as relaxation, breathing, stretching, and strengthening exercises to improve pelvic health. All study components occur online, allowing participation from any location. This trial suits individuals diagnosed with endometriosis by a doctor and who have experienced pain for at least three months. Participants will continue their regular treatment while using PelvicSense. As an unphased trial, this study offers a unique opportunity to explore new methods for managing endometriosis pain from home.

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.

What prior data suggests that the PelvicSense program is safe for endometriosis pain management?

Research has shown that PelvicSense, an online program for managing endometriosis pain, is safe and easy to use. The program includes activities such as relaxation, breathing exercises, and gentle stretching. It also provides information about the pelvic area and enhances the connection between the mind and muscles. No reports of harm or negative effects have emerged from using this program.

The trial is labeled as "Not Applicable" in phase, indicating that PelvicSense serves as a supportive therapy rather than a medication. This designation usually suggests a lower likelihood of side effects. Participants will continue their usual treatment, demonstrating that PelvicSense can be safely integrated into their current routine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

PelvicSense® is unique because it offers a home-based physiotherapy program specifically tailored for managing endometriosis pain. Unlike standard treatments, which often involve medication or surgery, PelvicSense® integrates relaxation, breathing, stretching, and strengthening exercises along with at-home manual therapy. Researchers are excited about this approach because it empowers individuals to actively participate in their pain management, potentially improving the mind-muscle connection and overall understanding of pelvic health. By educating participants on the anatomy and physiology of the pelvis, PelvicSense® aims to provide a holistic, non-invasive alternative that could complement or even reduce reliance on traditional medical treatments.

What evidence suggests that the PelvicSense program is effective for endometriosis pain?

Studies have shown that multimodal physical therapy, such as PelvicSense, can help reduce chronic pelvic pain. In this trial, participants will engage in the PelvicSense program, a home-based regimen that includes relaxation, breathing exercises, stretching, strengthening, and simple self-administered manual therapy. It also educates participants about pelvic anatomy and offers tips to improve the connection between the mind and muscles. This approach has benefited many women with chronic pelvic pain. While specific data for endometriosis is still being collected, the techniques used in PelvicSense have shown promise for similar conditions. ^{1 3 6 7 8}

Who Is on the Research Team?

Caroline Pukall, PhD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Self-identified diagnosis

I have been diagnosed with endometriosis in the last 3 months.

I am not fluent in English.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05909579?term=AREA%5BBasicSearch%5D(r%20r%2013)&rank=8

Investigating the Effectiveness of PelvicSense(R) on Pain ... This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with endometriosis. This study is ...

2. ctv.veeva.com ctv.veeva.com/study/investigating-the-effectiveness-of-pelvicsense-r-on-pain-and-sexual-outcomes-in-endometriosis

Investigating the Effectiveness of PelvicSense(R) on Pain and ... This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with endometriosis.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05909579

Investigating the Effectiveness of PelvicSense(R) on Pain and ... This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with endometriosis. This study is ...

4. withpower.com withpower.com/trial/phase-endometriosis-5-2023-2218c

Online Program for Endometriosis Pain · Info for Participants Trial Overview The PelvicSense online program's effectiveness on reducing pain and improving sexual outcomes in individuals with endometriosis is being tested.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002937824008275

Systematic Reviews Effectiveness of nonpharmacological ... This systematic review with meta-analysis revealed that multimodal physical therapy is effective in women with chronic pelvic pain with a high certainty of ...

6. pelvicsense.com pelvicsense.com/

PelvicSense PelvicSense can significantly lower chronic pelvic pain, one way is helping you elicit a sense of calm, of feeling safe and secure in your body. Listen to ...

7. pelvicsense.com pelvicsense.com/pelvicsense-program

PelvicSense - Program Details PelvicSense is an amazingly comprehensive tool that addresses the many facets of pain care: understanding pain and why you are stuck, a movement program.

8. aptapelvichealth.org aptapelvichealth.org/pelvicsense

PelvicSense The online home program is a biopsychosocial pelvic healing approach that teaches pain science, guided mind & body exercises, and strategies to help reduce ...