Clinical trial NCT06697548: Conservative Care for Pelvic Pain (C2P2) in Women Service Members
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: Pelvic health
Chronic pelvic pain
Physical therapy
Military
womens health
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: Congressionally Directed Medical Research Programs
First posted: 2024-11-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: 1 week and 1, 3, 6, and 12 months
measure: The Genitourinary Pain Index (GUPI)
timeFrame: 1 week and 1, 3, 6, and 12 months
Secondary outcomes:
measure: Numeric pain rating scale (NPRS)
timeFrame: 1 week and 1, 3, 6, and 12 months
measure: Pelvic Floor Muscle Tone
timeFrame: 1 week and 1, 3, 6, and 12 months
measure: Superficial Lumbopelvic Muscle Tone
timeFrame: 1 week and 1, 3, 6, and 12 months
measure: Pelvic Floor Pain Sensitivity
timeFrame: 1 week and 1, 3, 6, and 12 months
measure: Lumbopelvic Muscle Pain Sensitivity
timeFrame: 1 week and 1, 3, 6, and 12 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: U.S. Army Medical Center of Excellence (MEDCoE)
state: Texas
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
References: