Conservative Care for Pelvic Pain
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, since one group will receive usual care, which includes medications, it seems likely that you can continue your current medications.
What evidence supports the effectiveness of the treatment for chronic pelvic pain?
Is conservative care for pelvic pain safe for humans?
How does the conservative care treatment for pelvic pain differ from other treatments?
Conservative care for pelvic pain often involves pelvic floor physical therapy, which is a noninvasive treatment focusing on exercises and techniques to strengthen and relax the pelvic muscles. This approach is unique because it addresses the physical aspects of pelvic pain without surgery or medication, and may include methods like manual therapy, biofeedback, and electrical stimulation to improve function and reduce pain.16101112
What is the purpose of 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
This trial is for women service members with chronic pelvic pain lasting at least 3 months, not caused by recent surgery, infection, cancer or radiation. They shouldn't have other serious medical conditions or be pregnant/recently pregnant. A BMI over 33 (for Waco participants) and prior treatments like dry needling in the past 6 months are also exclusions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of three treatment regimens: Usual Care, Emerging Field-expedient Care, or Gold-standard Intravaginal Specialist Care
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Chronic Pelvic Pain Education
- Deep Paced Diaphragmatic Breathing Training
- Extrapelvic Dry Needling
- Extrapelvic Manual Therapy
- Intravaginal and intrarectal pelvic floor physical therapy
- Lumbopelvic and Hip Therapeutic Exercise
- Pain Neuroscience Education
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor University
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator