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

Conditions

• Chronic Pelvic Pain

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Pain Neuroscience Education — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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 — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jan 31, 2025

Status verified

Nov 2024

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Usual Care
  Usual Care Group will receive their current medical management care along with study-specific patient education and progressive home exercise.
• Experimental: Emerging Field-expedient Care
  Emerging Field-expedient Care Group will receive a combination of emerging nonvaginal interventions aimed at normalizing sensory, motor, and autonomic nervous system dysfunction including pain neuroscience education, diaphragmatic breathing training, and lumbopelvic manual therapy and dry needing treatment
• Active Comparator: Gold-standard Intravaginal Specialist Care
  Gold-standard Intravaginal Specialist Care Group will receive tailored intravaginal and intrarectal manual therapy and biofeedback intervention by a pelvic-health specialist.

Primary Outcome Measure

The Pelvic Floor Distress Inventory (PFDI-20) [ Time Frame: 1 week and 1, 3, 6, and 12 months ]

Central Contacts

• Shane Koppenhaver, PhD
  210-722-3671
  [email protected]
• Laurel Proulx, PhD
  816-699-5007‬
  [email protected]

Locations (2)

Find similar trials in San Antonio, TX

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