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Conservative Care for Pelvic Pain (C2P2) in Women Service Members
Sponsor: Baylor University
Summary
This study will test the effectiveness of emerging conservative interventions for treatment of chronic pelvic pain (CPP) that can be performed without intravaginal specialization. Participants with CPP will be randomly assigned to one of three groups. The first group will receive treatment based on what they normally would receive, including medications, education, and exercise (Usual Care Group). The second group will receive contemporary non-vaginal treatment including manual therapy, dry needling, and specific breathing training (Emerging Field-expedient Care Group). The third group will receive intravaginal treatment by a pelvic health specialist (Gold-standard Intravaginal Specialist Care Group). Participants will be asked about their pain and symptoms and have measurements taken of their pelvic and back muscles after 1, 3, 6, and 12 months. In addition to seeing which treatments work best, clinical decision tools (using medical and trauma history along with clinical examination) will be developed to identify women with CPP likely to respond favorably to non-vaginal conservative interventions. This study will help determine the best non-vaginal treatment strategies for women with CPP and help clinicians quickly determine which patients are likely to benefit from treatment by non-pelvic health physical therapists (e.g., in theater), vs. patients who should be referred for pelvic health specialty care.
Official title: Conservative Care for Pelvic Pain (C2P2) in Women Service Members: A Multisite, Multigroup Non-inferiority Randomized Clinical Trial With Development of Clinical Decision Tools
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-01
Completion Date
2028-06
Last Updated
2024-11-20
Healthy Volunteers
No
Conditions
Interventions
Pain Neuroscience Education
Participants will watch and discuss a short (5-minute) standardized pain neuroscience education video with their treating provider. The video explains and illustrates how chronic pain is different than acute pain in that it concerns nervous system hypersensitivity more than local tissue damage. Pain neuroscience education principles from the video will then be used to throughout all interventions to coach the participants through graded exposure of activities that may have previously been painful or provoked anxiety.
Lumbopelvic and Hip Therapeutic Exercise
These motor control exercises will focus on proprioception, coordination, and sensorimotor control training and include progressive exercises that focus on transversus abdominis, lumbar multifidus, diaphragmatic, pelvic floor muscles, and deep hip stabilizers. Exercises will progress from more stabilized (e.g., pelvic tilt, cat and cow) to less stabilized and more dynamic and functional (e.g., forward bending, eccentric squat) to mimic the demands of work duty. Exercise will be trained and progressed during the clinical visits and be performed daily at home.
Extrapelvic Manual Therapy
Thrust and non-thrust manual therapy will be applied to the lumbar facet, sacroiliac, and hip joints based upon the clinical exam in a semi-standardized manner
Extrapelvic Dry Needling
Dry needling treatment to muscles of the lumbopelvic and upper thigh regions in a semi-standardized manner based upon a palpatory examination. The palpatory examination will include the erector spinae, lumbar multifidi, gluteus medius/minimus, piriformis, illiacus, and hip adductor muscles.
Deep Paced Diaphragmatic Breathing Training
The breathing intervention will start with education describing the link between the diaphragm and the pelvic floor to include awareness of any breath holding patterns and finding positions that facilitate expansion of the ribs, abdominals, and pelvic floor muscles with inhalation. Then progressive training will be given to encourage deep breathing at a pace of approximately 6 breaths per minute.
Chronic Pelvic Pain Education
During the first visit, participants will receive and briefly discuss the 2023 standardized patient educational handout created by the International Pelvic Pain Society with their treating provider. The educational handout describes chronic pelvic pain etiology, typical symptoms, examination, and treatments.
Intravaginal and intrarectal pelvic floor physical therapy
Superficial vulvar, perineal and intravaginal manual therapy and biofeedback utilizing commonly used techniques in previous research selected based on identified impairments from the pelvic floor examination will be performed.
Locations (2)
U.S. Army Medical Center of Excellence (MEDCoE)
San Antonio, Texas, United States
Baylor University
Waco, Texas, United States