This study is being done to better understand and improve treatment for myofascial pelvic pain, a common cause of long-lasting pelvic pain in women. Myofascial pelvic pain is related to tight or dysfunctional pelvic floor muscles and can cause pain as well as bladder, bowel, and sexual problems. Current clinical evaluations mostly rely on physical examination and patient-reported symptoms and do not fully measure how the pelvic floor muscles are functioning. The purpose of this study is to measure pelvic floor muscle function using a noninvasive imaging method called near-infrared spectroscopy, or NIRS. This method measures changes in muscle blood flow and oxygen levels during muscle contraction and relaxation. The study will examine whether pelvic floor muscle function improves after different treatments and whether these physiologic changes are associated with improvements in pain and symptoms. The study will enroll 120 adult women who have had pelvic pain for at least three months and have pelvic floor muscle tenderness on examination. Participants will be randomly assigned to one of three groups: education with relaxation exercises, pelvic floor physical therapy focused on myofascial release, or vaginal medication used to help relax pelvic floor muscles. Participants will take part in four study visits over a six-month period. During these visits, they will complete questionnaires about pain and pelvic symptoms, undergo pelvic floor examinations, and have pelvic floor muscle imaging using the NIRS device while performing brief muscle contractions and relaxations. Some visits will also include collection of blood, urine, and vaginal samples to measure inflammation. The information gained from this study may help improve the diagnosis and treatment of myofascial pelvic pain by providing objective measures of pelvic floor muscle function and identifying which treatments are most effective for different patients.
STUDY OVERVIEW This is a prospective, randomized, controlled clinical study designed to objectively measure pelvic floor muscle (PFM) physiology and inflammatory changes in women with myofascial pelvic pain (MPP). The study uses a novel, transvaginal near-infrared spectroscopy (NIRS) system to assess pelvic floor muscle oxygenation, hemodynamics, and recovery during standardized contraction and relaxation tasks. The overarching goal is to improve objective diagnosis, phenotyping, and personalized treatment of MPP. Scientific Rationale Myofascial pelvic pain is a common contributor to chronic pelvic pain in women and is characterized by pelvic floor muscle hypertonicity, impaired muscle perfusion, local acidosis, and accumulation of inflammatory mediators. These physiologic abnormalities contribute to pain as well as bladder, bowel, and sexual dysfunction. Current clinical evaluation relies largely on subjective examination and patient-reported symptoms, which limits precision in diagnosis and treatment selection. Preliminary work has demonstrated that pelvic floor NIRS imaging can reliably distinguish women with MPP from asymptomatic controls and can identify physiologic impairments such as reduced muscle oxygenation and delayed recovery following contraction. This study evaluates whether targeted myofascial therapies improve these objective physiologic measures and whether changes in muscle physiology correlate with symptom improvement and inflammatory biomarkers. STUDY OBJECTIVES Primary Objective To determine whether pelvic floor muscle fitness, measured using NIRS-derived oxygenation parameters, improves following myofascial-directed treatments in women with MPP. Secondary Objectives To characterize NIRS-derived physiologic patterns associated with symptom severity and pelvic floor dysfunction. To assess relationships between NIRS measures and systemic and local inflammatory biomarkers. To identify physiologic predictors of treatment response using machine-learning-based analytic approaches. STUDY DESIGN Design: Prospective, randomized, controlled trial Sample size: 120 adult women with myofascial pelvic pain Randomization: 1:1:1 allocation Treatment arms: Education and generalized relaxation (control) Myofascially-directed pelvic floor physical therapy Pharmacologic pelvic floor muscle relaxation Study duration: Six months per participant Study visits: Baseline, 1-2 weeks, 3 months, and 6 months Total participant time: Approximately four hours across all visits STUDY PROCEDURES Baseline Visit After informed consent, participants complete validated questionnaires assessing pelvic pain, urinary, bowel, sexual function, psychological symptoms, and quality of life. Participants also complete two 24-hour bladder and bowel diaries. Clinical assessments include urinalysis and post-void residual if not recently documented, standardized pelvic examination with grading of muscle strength and myofascial tenderness, perineometry, surface electromyography, and bulbospongiosus reflex testing. Pelvic floor NIRS imaging is performed transvaginally during a guided 10-minute protocol involving repeated contraction and relaxation exercises, capturing real-time oxygenated and deoxygenated hemoglobin data across multiple circumferential channels. Biologic specimens, including blood, urine, and vaginal samples, are collected for inflammatory biomarker analysis. Follow-Up Assessments Participants return at 1-2 weeks, 3 months, and 6 months to repeat symptom questionnaires, bladder and bowel diaries, pelvic floor examination, and NIRS imaging. Participants also complete a patient global impression of improvement assessment at all visits after treatment. Biologic specimen collection is repeated at the early post-treatment visit. DATA MANAGEMENT AND SAFETY All study data are collected and managed using secure, HIPAA-compliant electronic data capture systems. Data are de-identified at the time of entry. An independent monitoring process oversees recruitment, protocol adherence, and adverse events. All study procedures are considered minimal risk and consistent with standard gynecologic and pelvic floor physical therapy care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Near-infrared spectroscopy (NIRS) is a noninvasive imaging technique used in this study to assess pelvic floor muscle physiology. The NIRS device uses near-infrared light to measure changes in oxygenated and deoxygenated hemoglobin within the pelvic floor muscles, providing real-time information about muscle blood flow, oxygenation, and recovery during contraction and relaxation. The device is used transvaginally during a standardized protocol that includes brief, guided pelvic floor muscle contractions and relaxations. NIRS measurements are used for assessment purposes only and are not intended for diagnosis or treatment.
UCLA
Los Angeles, California, United States
Change in pelvic floor muscle oxygenation with treatment
Change from baseline in pelvic floor muscle oxygenation response to standardized contraction, measured using near-infrared spectroscopy (NIRS) after treatment interventions designed to alter pelvic floor muscle fitness
Time frame: Baseline to 3 months
Change in pelvic floor muscle recovery kinetics after pelvic floor therapies
Change from baseline in pelvic floor muscle oxygenation recovery time following contraction, measured using NIRS, with pelvic floor-directed therapies
Time frame: Baseline to 3 months
Correlation of change in pelvic pain severity with NIRS metrics
Change from baseline in average pelvic pain intensity measured using a numeric rating scale (0-10) as correlated with metrics of pelvic floor muscle oxygenation
Time frame: Baseline to 3 months and 6 months
Patient Global Impression of Improvement (PGI-I)
Participant-reported overall improvement in pelvic symptoms using the Patient Global Impression of Improvement (PGI-I) scale after pelvic-floor directed therapies. The PGI-I is a single-question, patient-reported scale used to measure perceived treatment response compared to a baseline, which is rated on a seven-point scale from 1 (Very much better) to 7 (Very much worse).
Time frame: 3 months and 6 months
Change in inflammatory biomarkers
Change from baseline in systemic and local inflammatory biomarkers measured from blood, urine, and vaginal samples after pelvic-floor directed therapies. This exploratory aim will examine a wide-range of inflammatory mediators in each biological sample, including: EGF, Eotaxin/CCL11, G-CSF, GM-CSF, IFNα2, IFNγ, IL-1α, IL-1β, IL-1RA, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8/CXCL8, IL-10, IL-12 (p40), IL-12(p70), IL-13, IL-15, IL-17A/CTLA8, IL-17E/IL-25, IL-17F, IL-18, IL-22, IP-10/CXCL10, MCP-1/CCL2, M-CSF, MIG/CXCL9, MIP-1α/CCL3, MIP-1β/CCL4, PDGF-AA, PDGF-AB/BB, RANTES/CCL5, TNFα, TNFβ/LTA, VEGF-A. While the primary analysis will examine IL-6, IL-8, and TNF-β levels before and after treatment (measure in pg/mL), as these have been implicated previously in other myofascial pain conditions, the additional biomarkers may serve to provide additional insight into disease pathophysiology.
Time frame: Baseline to 1-2 weeks after therapy
Change in the Female Genitouruinary Pain Index
Change from baseline in patient-reported pelvic floor-related symptoms, including urinary, pain- and health-related quality of life will be measured using the validated female Genitourinary Pain Index (fGUPI) (scored 0-45, with higher numbers indicated worse pain and quality-of-life).
Time frame: Baseline to 3 months and 6 months
Change in Colorectal Functional Outcome questionnaire (COREFO)
Change from baseline in patient-reported pelvic floor-related and bowel symptoms will be measured using the Colorectal Functional Outcome questionnaire (COREFO) (scored 0-100, where 100 indicates the worst possible bowel function)
Time frame: Baseline to 3 months and 6 months
Change in International Consultation on Incontinence Questionnaire-female Lower Urinary Tract Symptoms (ICIQ-fLUTS)
Change from baseline in patient-reported pelvic floor-related and urinary symptoms, will be measured using the International Consultation on Incontinence Questionnaire-female Lower Urinary Tract Symptoms (ICIQ-fLUTS) (scored 0-48, where higher scores indicate more severe urinary symptoms )
Time frame: Baseline to 3 months and 6 months
Change in Pelvic Floor Distress Index (PFDI-20)
Change from baseline in patient-reported pelvic floor-related, urinary, bowel, and pain symptoms will be measured using the validated Pelvic Floor Distress Index (PFDI-20) (scored 0-300, where higher scores indicate more severe symptoms).
Time frame: Baseline to 3 months and 6 months
Change in Female Sexual Functional Index (FSFI)
Change from baseline in patient-reported sexual symptoms will be measured using validated questionnaires:Female Sexual Functional Index (FSFI) (scored 2-36, where higher scores indicate better sexual function)
Time frame: Baseline to 3 months and 6 months
Change in the Hospital Anxiety and Depression Scale (HADS)
Change from baseline in patient-reported anxiety and depression symptoms will be measured using the validated Hospital Anxiety and Depression Scale (HADS) (scored 0-42, with higher scores indicating higher severity symptoms).
Time frame: Baseline to 3 months and 6 months
Change in the Short Form 12 (SF-12)
Change from baseline in patient-reported health-related quality of life will be measured using the validated Short Form 12 (SF-12), which includes the Physical Component Summary (PCS) and Mental Component Summary (MCS), both weighted assessments measured such that 50 is the median score for the population, meaning that scores below 50 suggest below-average perceived health.
Time frame: Baseline to 3 months and 6 months
Change in Whole Person Health Index (WPHI)
Change from baseline in patient-reported overall health, will be measured using the validated Whole Person Health Index (WPHI), which includes 9 items, each of which is measured on a 5-point Likert scale in which higher scores indicate better self-perceived health.
Time frame: Baseline to 3 months and 6 months
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