Conservative Care for Pelvic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new ways to treat chronic pelvic pain (CPP) without specialized internal procedures. Researchers will compare three treatment methods: usual care with medication and exercise, innovative non-vaginal treatments like manual therapy and dry needling, and specialized internal therapy by a pelvic health expert. The goal is to determine which approach works best for women with persistent pelvic pain. Women who have experienced pelvic pain for at least three months, affecting their daily life, might be suitable for this trial. Participants will also assist in developing tools to predict who will benefit most from these treatments. As an unphased trial, this study offers a unique opportunity for participants to contribute to pioneering research that could improve treatment options for chronic pelvic pain.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments tested in this trial for chronic pelvic pain (CPP) are generally safe based on previous studies.
For Pain Neuroscience Education, research indicates it effectively reduces pain and enhances understanding of pain without causing significant side effects. It is usually well-tolerated and can help lessen disability and emotional issues.
Deep Paced Diaphragmatic Breathing Training has been studied for its impact on pain and quality of life. Results suggest it is safe and can improve symptoms related to pelvic pain and other conditions, with no major negative effects reported.
Extrapelvic Dry Needling targets muscles outside the pelvis to relieve pain. Studies have shown it reduces pain in women with CPP, with no serious side effects noted.
Manual Therapy involves physical manipulation of muscles. Evidence suggests it reduces pain and improves physical function. It is generally safe and well-tolerated in patients with CPP.
Lumbopelvic and Hip Therapeutic Exercise focuses on exercises for the lower back and hips. Research has shown these exercises reduce pain and improve quality of life in women with similar conditions, with a good safety record.
These treatments have been studied separately and are generally safe to use. However, individual experiences can vary, so discussing options with a healthcare provider is recommended.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative, non-invasive techniques for managing chronic pelvic pain. Unlike standard treatments that often focus on direct interventions like medication or surgery, this trial investigates methods such as deep paced diaphragmatic breathing and extrapelvic manual therapy, aiming to address the sensory and motor dysfunctions that contribute to pain. By combining these approaches with pain neuroscience education, the trial seeks to provide a holistic alternative that could enhance the quality of life for those suffering from pelvic pain. This method emphasizes a more comprehensive understanding of pain management, potentially offering a new avenue for relief without the side effects associated with conventional treatments.
What evidence suggests that this trial's treatments could be effective for chronic pelvic pain?
Research has shown that understanding how pain works can reduce pain and disability in conditions like fibromyalgia and chronic low back pain. This finding suggests it might also help with chronic pelvic pain (CPP). In this trial, participants in the Emerging Field-expedient Care arm will receive a combination of non-vaginal interventions, including pain neuroscience education, deep paced diaphragmatic breathing training, and extrapelvic manual therapy and dry needling. Training in deep, slow breathing has been found to raise pain tolerance and improve mood, potentially benefiting those with CPP. Dry needling outside the pelvic area can reduce pain in women with CPP by addressing muscle and nerve issues. Manual therapy has also effectively reduced pain for women with CPP. Together, these new non-vaginal treatments show promise in managing CPP by improving pain, muscle function, and overall well-being.26789
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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