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

NCT06697548 | Not Yet Recruiting

• 2 other identifiers: OR230127HT94252410709
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pelvic Pain

Keywords

Pelvic health; Chronic pelvic pain; Physical therapy; Military; womens health

Outcome Measures

Primary Outcomes (2)

• The Pelvic Floor Distress Inventory (PFDI-20)

  The Pelvic Floor Distress Inventory (PFDI-20) is a 20-item questionnaire that assesses the frequency and severity of pelvic floor symptoms. It consists of 3 subscales: the pelvic floor distress inventory 6 (POPDI-6), the colorectal anal distress inventory 8 (CRADI-8), and the urinary distress inventory 6 (UDI-6). Each question is rated on a scale of 0-4 with 0 representing "no symptoms," and 4 representing "quite a bit." Higher scores represent more bothersome symptoms.

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

• The Genitourinary Pain Index (GUPI)

  The Genitourinary Pain Index (GUPI) is 9-item questionnaire that assesses presence, location, frequency, quality and quantity of genitourinary pain in both men and women.

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

Secondary Outcomes (5)

• Numeric pain rating scale (NPRS)

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

• Pelvic Floor Muscle Tone

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

• Superficial Lumbopelvic Muscle Tone

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

• Pelvic Floor Pain Sensitivity

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

• Lumbopelvic Muscle Pain Sensitivity

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

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

Usual Care Group will receive their current medical management care along with study-specific patient education and progressive home exercise.

Other: Lumbopelvic and Hip Therapeutic Exercise; Other: Chronic Pelvic Pain Education

Emerging Field-expedient Care

EXPERIMENTAL

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

Other: Pain Neuroscience Education; Other: Lumbopelvic and Hip Therapeutic Exercise; Other: Extrapelvic Manual Therapy; Other: Extrapelvic Dry Needling; Other: Deep Paced Diaphragmatic Breathing Training; Other: Chronic Pelvic Pain Education

Gold-standard Intravaginal Specialist Care

ACTIVE COMPARATOR

Gold-standard Intravaginal Specialist Care Group will receive tailored intravaginal and intrarectal manual therapy and biofeedback intervention by a pelvic-health specialist.

Other: Pain Neuroscience Education; Other: Lumbopelvic and Hip Therapeutic Exercise; Other: Deep Paced Diaphragmatic Breathing Training; Other: Chronic Pelvic Pain Education; Other: Intravaginal and intrarectal pelvic floor physical therapy

Interventions

Pain Neuroscience Education OTHER

Participants will watch and discuss a short (5-minute) standardized pain neuroscience education video with their treating provider. The video explains and illustrates how chronic pain is different than acute pain in that it concerns nervous system hypersensitivity more than local tissue damage. Pain neuroscience education principles from the video will then be used to throughout all interventions to coach the participants through graded exposure of activities that may have previously been painful or provoked anxiety.

Emerging Field-expedient Care; Gold-standard Intravaginal Specialist Care

Lumbopelvic and Hip Therapeutic Exercise OTHER

These motor control exercises will focus on proprioception, coordination, and sensorimotor control training and include progressive exercises that focus on transversus abdominis, lumbar multifidus, diaphragmatic, pelvic floor muscles, and deep hip stabilizers. Exercises will progress from more stabilized (e.g., pelvic tilt, cat and cow) to less stabilized and more dynamic and functional (e.g., forward bending, eccentric squat) to mimic the demands of work duty. Exercise will be trained and progressed during the clinical visits and be performed daily at home.

Emerging Field-expedient Care; Gold-standard Intravaginal Specialist Care; Usual Care

Extrapelvic Manual Therapy OTHER

Thrust and non-thrust manual therapy will be applied to the lumbar facet, sacroiliac, and hip joints based upon the clinical exam in a semi-standardized manner

Emerging Field-expedient Care

Extrapelvic Dry Needling OTHER

Dry needling treatment to muscles of the lumbopelvic and upper thigh regions in a semi-standardized manner based upon a palpatory examination. The palpatory examination will include the erector spinae, lumbar multifidi, gluteus medius/minimus, piriformis, illiacus, and hip adductor muscles.

Emerging Field-expedient Care

Deep Paced Diaphragmatic Breathing Training OTHER

The breathing intervention will start with education describing the link between the diaphragm and the pelvic floor to include awareness of any breath holding patterns and finding positions that facilitate expansion of the ribs, abdominals, and pelvic floor muscles with inhalation. Then progressive training will be given to encourage deep breathing at a pace of approximately 6 breaths per minute.

Emerging Field-expedient Care; Gold-standard Intravaginal Specialist Care

Chronic Pelvic Pain Education OTHER

During the first visit, participants will receive and briefly discuss the 2023 standardized patient educational handout created by the International Pelvic Pain Society with their treating provider. The educational handout describes chronic pelvic pain etiology, typical symptoms, examination, and treatments.

Emerging Field-expedient Care; Gold-standard Intravaginal Specialist Care; Usual Care

Intravaginal and intrarectal pelvic floor physical therapy OTHER

Superficial vulvar, perineal and intravaginal manual therapy and biofeedback utilizing commonly used techniques in previous research selected based on identified impairments from the pelvic floor examination will be performed.

Gold-standard Intravaginal Specialist Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• 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).
• Soldiers in an Advanced Individual Training (AIT) status.
• 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 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).
• Inability to legally provide informed consent for any other reason.

Sponsors & Collaborators

• Baylor University: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (2)

U.S. Army Medical Center of Excellence (MEDCoE)

San Antonio, Texas, 78234, United States

Location

Baylor University

Waco, Texas, 76701, United States

Location

Central Study Contacts

Shane Koppenhaver, PhD

CONTACT

210-722-3671; shane_koppenhaver@baylor.edu

Laurel Proulx, PhD

CONTACT

816-699-5007‬; laurel_proulx@baylor.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)