Conservative Care for Pelvic Pain (C2P2) in Women Service Members
- Conditions
- Chronic Pelvic Pain
- Registration Number
- NCT06697548
- Lead Sponsor
- Baylor University
- Brief 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.
- Detailed Description
This trial will measure both clinical outcomes (pain, pelvic floor symptoms, work/duty absenteeism) and physiologic outcomes (pelvic floor and lumbopelvic muscle function and pain sensitivity) at 1 week and after 1, 3, 6, and 12 months of three different conservative physical therapy treatments. It is hypothesized that women who receive emerging field-expedient care will report greater improvements than those who receive only usual care, and their outcomes will be no worse than women who receive gold-standard intravaginal specialist care. Additionally, clinical decision tools incorporating characteristics from medical and trauma history, along with clinical examination, will be developed to identify women with CPP likely to respond favorably to emerging field-expedient care vs. requiring gold-standard intravaginal specialist care.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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.
- 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).
- Chronic debilitating medical conditions (e.g., fibromyalgia, lupus, complex regional pain syndrome, multiple sclerosis or other progressive neurologic condition).
- Currently pregnant or pregnancy in the last 6 months.
- Body mass index over 33 (Waco participants only due to limitation of the instrumentation).
- Soldiers in an Advanced Individual Training (AIT) status.
- 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.
- 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).
- Inability to legally provide informed consent for any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Pelvic Floor Distress Inventory (PFDI-20) 1 week and 1, 3, 6, and 12 months The Pelvic Floor Distress Inventory (PFDI-20) is a 20-item questionnaire that assesses the frequency and severity of pelvic floor symptoms. It consists of 3 subscales: the pelvic floor distress inventory 6 (POPDI-6), the colorectal anal distress inventory 8 (CRADI-8), and the urinary distress inventory 6 (UDI-6). Each question is rated on a scale of 0-4 with 0 representing "no symptoms," and 4 representing "quite a bit." Higher scores represent more bothersome symptoms.
The Genitourinary Pain Index (GUPI) 1 week and 1, 3, 6, and 12 months The Genitourinary Pain Index (GUPI) is 9-item questionnaire that assesses presence, location, frequency, quality and quantity of genitourinary pain in both men and women.
- Secondary Outcome Measures
Name Time Method Numeric pain rating scale (NPRS) 1 week and 1, 3, 6, and 12 months Participants will rate their current pain on a scale of 0-10 with zero being no pain at all and 10 being the worst pain imaginable. Subjects will also rate their worst pain within the past week and their pain at its best within the last week, to gain an assessment of variability and intensity of pain.
Pelvic Floor Muscle Tone 1 week and 1, 3, 6, and 12 months On a subset of 150 participants, pelvic floor muscle tone will be estimated from shear wave elastography ultrasound (US).
Superficial Lumbopelvic Muscle Tone 1 week and 1, 3, 6, and 12 months On a subset of 150 participants, resting tone of several lumbopelvic muscles will be measures using a MyotonPRO device.
Pelvic Floor Pain Sensitivity 1 week and 1, 3, 6, and 12 months On a subset of 150 participants, pelvic floor pain sensitivity will be assessed using pain algometry.
Lumbopelvic Muscle Pain Sensitivity 1 week and 1, 3, 6, and 12 months On a subset of 150 participants, Pain sensitivity of the same lumbopelvic muscles and locations assessed using the MyotonPRO will be measured using a digital hand-held pressure algometer.
Trial Locations
- Locations (2)
U.S. Army Medical Center of Excellence (MEDCoE)
🇺🇸San Antonio, Texas, United States
Baylor University
🇺🇸Waco, Texas, United States