[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641011":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":66,"collaborators":69,"id":73,"slug":32,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":32,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":32,"enrollmentInfo":81,"targetDuration":32,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":113,"whyStopped":32,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Education","PLACEBO_COMPARATOR","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.",[13],"Diagnostic Test: Near Infrared Imaging",{"label":15,"type":16,"description":17,"interventionNames":18},"Pelvic Floor Physical Therapy","ACTIVE_COMPARATOR","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.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Pharmacological Release","EXPERIMENTAL","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.",[13],[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[9,15,20],[31],"NIRS",null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Keila S Kimura, B.S.","CONTACT","310-825-8427","kskimura@mednet.ucla.edu",[40],{"facility":41,"status":32,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"UCLA","Los Angeles","California","90095","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-118.24368,34.05223,{"lat":51,"lon":50},[54,58,59,61,64],{"name":55,"role":36,"phone":56,"phoneExt":32,"email":57},"A Lenore Ackerman, MD, PhD","310-794-7700","aackerman@mednet.ucla.edu",{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"name":55,"role":60,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"name":62,"role":63,"phone":32,"phoneExt":32,"email":32},"Michelle Tororsis, MD","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":32,"phoneExt":32,"email":32},"Jeffery Chiang, PhD",{"type":60,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Anne Lenore Ackerman","Associate Professor of Urology at UCLA, Director of Research, Division of Female Pelvic Medicine and Reconstructive Surgery at UCLA",[70],{"name":71,"class":72},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100641011",false,"NCT07605598","Measuring Pelvic Floor Muscle Fitness Before and After Treatment","Quantitative Assessment of Pelvic Floor Muscle Fitness in Myofascial Pelvic Pain Before and After Myofascially-Directed Therapies","Inclusion Criteria:\n\nWomen over 18 years of age\n\nPelvic Pain for more than 3 months\n\nReport an average daily pain intensity score of at least 4 on a 0 to 10 scale\n\nPalpable trigger\u002Ftender points in internal pelvic floor muscles on standardized myofascial pelvic floor exam\n\nWilling to refrain from new clinical treatment that may affect pain during the study period\n\nExclusion Criteria\n\nInability to participate in clinic visits\n\nPrior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacral neuromodulation, intradetrusor Botox®) in the past 6 months\n\nActive UTI or vaginal infection\n\nPregnancy or childbirth in the past 12 months, currently planning a pregnancy\n\nIllicit Drug addiction\u002Fregular use of controlled substances (including marijuana use in the past 2 weeks or during the study period)\n\nPelvic floor physical therapy in the past 3 months\n\nMalignancy or other serious medical condition (e.g., poorly controlled diabetes \\[HgA1c \\> 8\\], chronic renal disease \\[GFR \\\u003C30\\], neurologic or rheumatic disease)\n\nDiagnosed with an alternate cause of pelvic pain (e.g., ulcerative interstitial cystitis, vestibulodynia, vulvar dermatoses, dysmenorrhea)\n\nUrinary retention with a PVR \\>150 mL\n\nGreater than stage 3 pelvic organ prolapse\n\nIndwelling vaginal devices (e.g., pessary, contraceptive ring. Not including Mirena IUD) that cannot be removed for the study\n\nInability to sign an informed consent, fill out questionnaires, or complete study interviews","FEMALE","18 Years",{"count":82,"type":83},120,"ESTIMATED","INTERVENTIONAL",[86],"NA","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.\n\nThe 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.\n\nThe 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.\n\nParticipants 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.\n\nThe 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.",[89,90,91,92],"Myofacial Pain","Pelvic Pain","Myofascial Pelvic Pain","Chronic Pelvic Pain",[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"myofascial pelvic pain","chronic pelvic pain","pelvic floor muscle dysfunction","pelvic floor myalgia","pelvic floor hypertonicity","Near-infrared spectroscopy","NIRS imaging","Pelvic floor muscle oxygenation","Pelvic floor muscle blood flow","Pelvic floor muscle fitness","Pelvic floor physical therapy","Myofascial release therapy","Pelvic floor relaxation therapy","Intravaginal diazepam","Intravaginal baclofen","Pelvic floor muscle relaxation medication","Women's pelvic pain","Noninvasive pelvic floor assessment","Pelvic floor imaging","NOT_YET_RECRUITING","2026-05-21",{"date":116,"type":117},"2026-05-26","ACTUAL",{"date":119,"type":83},"2026-09-01",{"date":121,"type":83},"2029-07-01",{"name":5,"class":6},1]