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Conservative Care for Pelvic Pain

N/A

Waitlist Available

Research Sponsored by Baylor University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be between 18 and 65 years old

Must not have

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

Inability to legally provide informed consent for any other reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week and 1, 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare different treatments for chronic pelvic pain. Participants will be divided into three groups: one group will receive standard care, another group will receive non-vaginal treatments like manual therapy and dry

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort or bruising from manual therapies or dry needling, muscle soreness from exercises, and possible emotional distress due to discussing sensitive health issues during education sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatments like dry needling or injections for back pain in the last 6 months.

Select...

I am legally able to give my consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week and 1, 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week and 1, 3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week and 1, 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Genitourinary Pain Index (GUPI)

The Pelvic Floor Distress Inventory (PFDI-20)

Secondary study objectives

Lumbopelvic Muscle Pain Sensitivity

Numeric pain rating scale (NPRS)

Pelvic Floor Muscle Tone

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met