PelvicSense Program for Vulvodynia

Overseen By Caroline Pukall, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dr. Caroline Pukall

Disqualifiers: Under 18, Nonfluent English, 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 study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with provoked vestibulodynia. This study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. All aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in English, and experience pain due to provoked vestibulodynia for at least 3 months with a physician diagnosis. Participants are expected to continue their treatment as usual and this information will be documented throughout the study.

Will I have to stop taking my current medications?

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

How is the PelvicSense treatment for vulvodynia different from other treatments?

The PelvicSense treatment is unique because it is an online program specifically designed to address vulvodynia, a condition with no standard treatment, by potentially focusing on pelvic alignment and dynamics, which may influence pelvic pain. ^{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 provoked vestibulodynia, a condition causing pain in the vulvar region, for at least three months. Participants will engage in an online program called PelvicSense and must continue their usual treatment during the study.

Inclusion Criteria

Fluent in English

I have been diagnosed with peripheral vascular disease for at least 3 months.

Exclusion Criteria

I am not fluent in English.

Self-identified diagnosis

My peripheral vascular disease has lasted less than 3 months.

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 physiotherapy techniques

12 weeks

Remote sessions (online, email, 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 effectiveness of PelvicSense, a 3-month online program designed to help manage pain and improve sexual outcomes for those suffering from provoked vestibulodynia, is being tested. The study includes assessments before starting, after completing the program, and three months later.

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 using MRI and ultrasound to analyze pelvic landmarks in different seating positions found that internal and external landmark coordinates are generally statistically different, influenced by soft tissue thickness and posture changes.

Despite these differences, the accuracy of estimating pelvic orientation indexes (like tilt and rotation) was not significantly affected, suggesting that linear regressions can be used to correlate internal and external landmark positions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences between pelvic skin and bone landmark identification in different seated positions on spinal-cord injured subjects. Lalonde, NM., Dansereau, J., Aissaoui, R., et al.[2019]

A study involving 102 women found that those with dysmenorrhea (menstrual pain) had a greater pelvic torsion (2.4 degrees) compared to those without dysmenorrhea (1.7 degrees), indicating a potential link between pelvic alignment and menstrual pain.

The research utilized advanced measurement techniques (Formetric 4D) to assess pelvic alignment, suggesting that pelvic torsion may play a role in the experience of dysmenorrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between pelvic alignment and dysmenorrhea. Kim, MJ., Baek, IH., Goo, BO.[2020]

Patient Assisted Laparoscopy (PAL) significantly reduced the negative laparoscopy rate for patients with pelvic pain to less than 3%, compared to the typical 35% seen with traditional laparoscopic procedures under general anesthesia.

Out of 100 patients assessed, 88 were successfully evaluated, revealing that a majority (61 patients) had endometriosis, highlighting PAL's effectiveness in diagnosing specific causes of chronic pelvic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect on negative laparoscopy rate in chronic pelvic pain patients using patient assisted laparoscopy. Demco, LA.[2023]

A new 3-D numerical model of the pelvic cavity was created using magnetic resonance images, which helps in understanding the complex anatomy and mobility of the female pelvis.

This model allows for the non-destructive identification of pelvic structures, paving the way for better diagnosis and treatment of pelvic imbalances in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation of normal pelvic mobilities in building an MRI-validated biomechanical model. Cosson, M., Rubod, C., Vallet, A., et al.[2021]

In a study of 25 female adolescents with idiopathic scoliosis (AIS) and 12 controls, significant differences in pelvic dynamics were observed, particularly in pelvic alignment during various trunk-pelvis movements, indicating that scoliosis affects pelvic mobility and overall biomechanics.

The study found that the initial three-dimensional alignment of the pelvis is crucial for movement dynamics, with patients having distinct pelvic responses based on the type of scoliosis, particularly showing increased pelvic sagittal tilt in those with right thoracic-left lumbar curves during lateral bending and axial rotation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing pelvis dynamics in adolescent with idiopathic scoliosis. Pasha, S., Sangole, AP., Aubin, CE., et al.[2013]

References

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

Differences between pelvic skin and bone landmark identification in different seated positions on spinal-cord injured subjects. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

The relationship between pelvic alignment and dysmenorrhea. [2020]

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

Effect on negative laparoscopy rate in chronic pelvic pain patients using patient assisted laparoscopy. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Simulation of normal pelvic mobilities in building an MRI-validated biomechanical model. [2021]

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

Characterizing pelvis dynamics in adolescent with idiopathic scoliosis. [2013]