An interventional study of Pain Neuroscience Education and Lumbopelvic and Hip Therapeutic Exercise in Chronic Pelvic Pain, sponsored by Baylor University. Not yet recruiting at 2 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Baylor University · Not applicable, Interventional, and Treatment
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.
This trial will measure both clinical outcomes (pain, pelvic floor symptoms, work/duty absenteeism) and physiologic outcomes (pelvic floor and lumbopelvic muscle function and pain sensitivity) at 1 week and after 1, 3, 6, and 12 months of three different conservative physical therapy treatments. It is hypothesized that women who receive emerging field-expedient care will report greater improvements than those who receive only usual care, and their outcomes will be no worse than women who receive gold-standard intravaginal specialist care. Additionally, clinical decision tools incorporating characteristics from medical and trauma history, along with clinical examination, will be developed to identify women with CPP likely to respond favorably to emerging field-expedient care vs. requiring gold-standard intravaginal specialist care.
375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.
This study's planned enrollment of 300 is above the median of 54 across 273 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Baylor University is the lead sponsor of 40 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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
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.
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.
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
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 1 week and 1, 3, 6, and 12 months
Numeric pain rating scale (NPRS)
Participants will rate their current pain on a scale of 0-10 with zero being no pain at all and 10 being the worst pain imaginable. Subjects will also rate their worst pain within the past week and their pain at its best within the last week, to gain an assessment of variability and intensity of pain.
Time frame: 1 week and 1, 3, 6, and 12 months
Pelvic Floor Muscle Tone
On a subset of 150 participants, pelvic floor muscle tone will be estimated from shear wave elastography ultrasound (US).
Time frame: 1 week and 1, 3, 6, and 12 months
Superficial Lumbopelvic Muscle Tone
On a subset of 150 participants, resting tone of several lumbopelvic muscles will be measures using a MyotonPRO device.
Time frame: 1 week and 1, 3, 6, and 12 months
Pelvic Floor Pain Sensitivity
On a subset of 150 participants, pelvic floor pain sensitivity will be assessed using pain algometry.
Time frame: 1 week and 1, 3, 6, and 12 months
Lumbopelvic Muscle Pain Sensitivity
On a subset of 150 participants, Pain sensitivity of the same lumbopelvic muscles and locations assessed using the MyotonPRO will be measured using a digital hand-held pressure algometer.
Time frame: 1 week and 1, 3, 6, and 12 months
Plan to share: No — Depending upon where the findings of this study are published, sharing individual participant data might not be feasible.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Baylor University