Conservative Care for Pelvic Pain (C2P2) in Women Service Members

Launched by BAYLOR UNIVERSITY · Nov 19, 2024

Keywords

ClinConnect Summary

The Conservative Care for Pelvic Pain (C2P2) trial is studying different ways to treat chronic pelvic pain (CPP) in women service members. Participants will be randomly divided into three groups to see which treatment works best. One group will receive their usual care, which includes medications and exercise. The second group will try newer treatments that do not involve vaginal procedures, such as manual therapy, dry needling, and breathing exercises. The third group will receive care from a specialist who focuses on vaginal treatments. Over the course of the study, participants will share information about their pain and undergo some tests to measure muscle function at several points—after 1, 3, 6, and 12 months.

To be eligible for this trial, participants should have had pelvic pain for at least three months. However, there are some conditions that exclude individuals, such as recent surgeries or serious medical issues like fibromyalgia or pregnancy. The goal of this study is not only to find effective non-vaginal treatments but also to develop tools that help doctors quickly identify which women might benefit from these treatments versus those who need to see a specialist. Overall, this research aims to improve care for women suffering from chronic pelvic pain.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Pain of at least 3 months duration in the abdominal-lumbopelvic area, defined as below the umbilicus, between the two ilia, and above the pubic symphysis including the vulvar, perineal, and vaginal regions.
• Exclusion Criteria:
• • 1. Sign that pelvic pain may be due to other serious medical issue (recent history of abdominal pelvic surgery, current infection, disrupted tissue integrity, neoplasm, or history of radiation to the pelvic floor tissue or the tissues being measured for stiffness).
• • 2. Chronic debilitating medical conditions (e.g., fibromyalgia, lupus, complex regional pain syndrome, multiple sclerosis or other progressive neurologic condition).
• • 3. Currently pregnant or pregnancy in the last 6 months.
• • 4. Body mass index over 33 (Waco participants only due to limitation of the instrumentation).
• • 5. Soldiers in an Advanced Individual Training (AIT) status.
• • 6. Previous intervention to address lumbopelvic muscle stiffness or pain such as dry needling, injections, or soft tissue intervention of any kind in the past 6 months.
• • 7. Inability to read English at an 8th grade reading level (any participant unable to read the informed consent form, which will be written at an 8th grade level).
• • 8. Inability to legally provide informed consent for any other reason.