300 Participants Needed

Conservative Care for Pelvic Pain

Recruiting at 1 trial location
SK
LP
Overseen ByLaurel Proulx, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Baylor University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

There is some evidence suggesting that a multidisciplinary approach, which includes physiotherapy and other therapies, can help manage chronic pelvic pain in women. Techniques like pelvic floor physical therapy and mindfulness have shown potential benefits in reducing symptoms.12345

Is conservative care for pelvic pain safe for humans?

Conservative treatments like pelvic floor physical therapy and manual therapy are generally considered safe for managing pelvic pain, as they are noninvasive and focus on relieving muscle tension and pain.16789

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

I have had pain in my lower abdomen and pelvic area for at least 3 months.

Exclusion Criteria

I have had treatments like dry needling or injections for back pain in the last 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)
I have a chronic condition like fibromyalgia or MS.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three treatment regimens: Usual Care, Emerging Field-expedient Care, or Gold-standard Intravaginal Specialist Care

12 months
Visits at 1 week, 1, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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
Trial Overview The study compares three approaches to treating chronic pelvic pain: usual care with medications and exercise; non-vaginal treatments like manual therapy, dry needling, and breathing training; and specialized intravaginal treatment. It aims to find effective non-vaginal treatments and develop tools to predict who will benefit from them.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Emerging Field-expedient CareExperimental Treatment6 Interventions
Emerging Field-expedient Care Group will receive a combination of emerging nonvaginal interventions aimed at normalizing sensory, motor, and autonomic nervous system dysfunction including pain neuroscience education, diaphragmatic breathing training, and lumbopelvic manual therapy and dry needing treatment
Group II: Gold-standard Intravaginal Specialist CareActive Control5 Interventions
Gold-standard Intravaginal Specialist Care Group will receive tailored intravaginal and intrarectal manual therapy and biofeedback intervention by a pelvic-health specialist.
Group III: Usual CareActive Control2 Interventions
Usual Care Group will receive their current medical management care along with study-specific patient education and progressive home exercise.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials
65
Recruited
67,600+

Congressionally Directed Medical Research Programs

Collaborator

Trials
59
Recruited
10,600+

Findings from Research

Chronic pelvic pain treatment is complex and typically involves a combination of behavioral, medical, and procedural therapies, reflecting the multifaceted nature of the condition.
Recent advancements in understanding the neurobiology of chronic pelvic pain have led to the exploration of new treatment options, including neuromodulatory therapies and complementary medicine, alongside traditional focal therapies for specific pathologies.
New directions in the treatment of pelvic pain.Udoji, MA., Ness, TJ.[2021]
Chronic pelvic pain (CPP) significantly affects women's quality of life, and while physiotherapy is recommended as a treatment, the evidence supporting its effectiveness is limited and primarily derived from small, non-randomized studies.
Some evidence suggests that multidisciplinary interventions, including physiotherapy and Mensendieck somatocognitive therapy, may help manage CPP, but more high-quality randomized clinical trials are needed to establish definitive treatment guidelines.
Does evidence support physiotherapy management of adult female chronic pelvic pain? A systematic review.Loving, S., Nordling, J., Jaszczak, P., et al.[2019]

References

Pelvic floor physical therapy and mindfulness: approaches for chronic pelvic pain in women-a systematic review and meta-analysis. [2023]
Rehabilitation of the short pelvic floor. II: Treatment of the patient with the short pelvic floor. [2018]
Chronic pelvic pain: how many surgeries are enough? [2009]
New directions in the treatment of pelvic pain. [2021]
Does evidence support physiotherapy management of adult female chronic pelvic pain? A systematic review. [2019]
The Efficacy of Manual Therapy for Treatment of Dyspareunia in Females: A Systematic Review. [2022]
A prospective study of pelvic floor physical therapy: pain and psychosexual outcomes in provoked vestibulodynia. [2015]
Myofascial trigger points of the pelvic floor: associations with urological pain syndromes and treatment strategies including injection therapy. [2021]
Assessment of levator hiatal area using 3D/4D transperineal ultrasound in women with deep infiltrating endometriosis and superficial dyspareunia treated with pelvic floor muscle physiotherapy: randomized controlled trial. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Mensendieck somatocognitive therapy as treatment approach to chronic pelvic pain: results of a randomized controlled intervention study. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Pelvic disorders in women: chronic pelvic pain and vulvodynia. [2005]
12.United Statespubmed.ncbi.nlm.nih.gov
Pelvic floor physical therapy in urogynecologic disorders. [2006]
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