An interventional study of Near Infrared Imaging in Myofacial Pain, Pelvic Pain and Myofascial Pelvic Pain, sponsored by University of California, Los Angeles. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Diagnostic
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.
182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 132 interventional studies indexed under Facial Pain.
Browse Facial Pain studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women over 18 years of age
Pelvic Pain for more than 3 months
Report an average daily pain intensity score of at least 4 on a 0 to 10 scale
Palpable trigger/tender points in internal pelvic floor muscles on standardized myofascial pelvic floor exam
Willing to refrain from new clinical treatment that may affect pain during the study period
Exclusion Criteria
Inability to participate in clinic visits
Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacral neuromodulation, intradetrusor Botox®) in the past 6 months
Active UTI or vaginal infection
Pregnancy or childbirth in the past 12 months, currently planning a pregnancy
Illicit Drug addiction/regular use of controlled substances (including marijuana use in the past 2 weeks or during the study period)
Pelvic floor physical therapy in the past 3 months
or other serious medical condition (e.g., poorly controlled diabetes [HgA1c > 8], chronic renal disease [ \<30], neurologic or rheumatic disease)
Diagnosed with an alternate cause of pelvic pain (e.g., ulcerative interstitial cystitis, vestibulodynia, vulvar dermatoses, dysmenorrhea)
Urinary retention with a PVR >150 mL
Greater than stage 3 pelvic organ prolapse
Indwelling vaginal devices (e.g., pessary, ring. Not including Mirena IUD) that cannot be removed for the study
Inability to sign an , fill out questionnaires, or complete study interviews
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Education and Generalized Relaxation. Patients are educated about myofascial pelvic pain and given a home course of non-specific relaxation exercises administered via a virtual intervention of five 5-10 min videos.
Diagnostic Test: Near Infrared Imaging
Pelvic floor physical therapy with myofascial release will be performed by a designated female physical therapist who is a Board-Certified Clinical Specialist in Women's Health Physical Therapy. The methods and approaches used will be at the discretion of the therapist, based on an individual assessment of symptoms and detailed pelvic floor assessment.
Diagnostic Test: Near Infrared Imaging
Compounded intravaginal diazepam 0.5% and baclofen 0.4% ointment. Participants receive a compounded intravaginal ointment containing diazepam (0.5%) and baclofen (0.4%) to promote pelvic floor muscle relaxation. Medication is initiated nightly and may be titrated up to three times daily based on symptom response and tolerability.
Diagnostic Test: Near Infrared Imaging
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.
Also known as: NIRS
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
Prediction of treatment response using NIRS metrics
The Near InfraRed Spectroscopic (NIRS) pelvic floor muscle measurements are obtained vaginally during a series of pelvic floor muscle contractions, both short- and long-duration. Features abstracted from the resulting NIRS waveforms \[change in oxygenated hemoglobin (measure in nM) from baseline to during MVC, the sustainable duration of SMVC (sec), and the decrease in the change in oxygenated hemoglobin with MVC over a series of contractions (measured in nM, indicative of muscle fatigue)\] will be combined using generalized linear models to create a single, unitless predictive score that will be correlated with treatment responses. The magnitude of the clinical treatment response will be measured as a decrease in pain scores expressed as a continuous variable using the Numeric Rating Scale (NRS), a validated 11-point, patient-reported tool.
Time frame: Baseline to 6 months
Plan to share: Yes — De-identified individual participant data (IPD) underlying published results will be shared with qualified researchers upon reasonable request. Data will be de-identified in accordance with applicable privacy regulations and institutional policies. Requests for data access must include a brief description of the proposed research, planned analyses, and data protection measures, and will be reviewed by the study investigators. Data will be shared through a secure data transfer mechanism following execution of an appropriate data use agreement. Data will be available beginning after publication of the primary study results and will remain available for a defined period consistent with institutional and funding agency requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: De-identified individual participant data (IPD) and supporting documents will be available beginning after publication of the primary study results. Data and supporting information will remain available for up to five years following publication, or longer as required by institutional and funding agency data-sharing policies.
Access criteria: Access to de-identified individual participant data and supporting information will be provided to qualified researchers upon reasonable request. Researchers must submit a written proposal describing the research question, planned analyses, and data security measures. Requests will be reviewed and approved by the study investigators. Data and documents will be shared only after execution of an appropriate data use agreement and will be provided via secure electronic file transfer. Shared materials will include only de-identified data and redacted documents necessary to support the approved research purpose.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 53 non-industry interventional studies with no phase under Facial Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 24 months is above that.
Counting every sponsor, half of 57 studies reached it within 17 months; a quarter within 8 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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