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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorBaylor University

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Pain Neuroscience Education
  • Lumbopelvic and Hip Therapeutic Exercise
  • Extrapelvic Manual Therapy
  • Extrapelvic Dry Needling
  • Deep Paced Diaphragmatic Breathing Training
  • Chronic Pelvic Pain Education
  • Intravaginal and intrarectal pelvic floor physical therapy

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Baylor University

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator