[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606891":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Subjects",null,"Women age 18 or older without pelvic pain or other genitourinary complaints",[13],"Diagnostic Test: Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy",{"label":15,"type":10,"description":16,"interventionNames":17},"Myofascial Pelvic Pain Subjects","Women age 18 or older with pelvic floor muscle pain or tender points",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy","This study will develop and test an instrument to establish a normal range for near infrared spectroscopy (NIRS) optical changes associate with pelvic floor exercise in adult women based on the test-to test (intra-day) reliability of oxygen kinetics related to contraction of the pelvic floor muscle. We will establish the relationship between the quantitative NIRS data, the condition of Myofascial pelvic musculature and the symptomatology of MPP and related comorbidities. We will also evaluate prospectively the effectiveness of these data in predicting effective treatment modalities. Finally, we will optimize a training regime for non-specialists to allow this technique to be used in a variety of settings. The development of this device and validation of its relevance to diagnosis and treatment of MPP will provide effective care sooner and at a lower cost than current procedures. It will also reduce inequities in the availability of care to underserved populations.",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Keila Kimura","CONTACT","310-794-5910","bladderpainucla@gmail.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"UCLA Center for Women's Pelvic Health","RECRUITING","Los Angeles","California","90095","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-118.24368,34.05223,{"lat":43,"lon":42},[46,47],{"name":10,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":48,"role":49,"phone":10,"phoneExt":10,"email":10},"Anne L Ackerman, MD PHD","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Anne Lenore Ackerman","Associate Professor of Urology",[54],{"name":55,"class":56},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100606891","nirs-for-the-diagnosis-of-myofascial-pelvic-pain-100606891",false,"NCT07181447","NIRS for the Diagnosis of Myofascial Pelvic Pain","Quantitative Assessment of Pelvic Floor Muscle Fitness in Myofascial Pelvic Pain","Inclusion Criteria:\n\n* Women between 18 and 100 years of age\n* Pelvic pain for more than 6 months duration\n* Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale)\n* Palpable trigger\u002Ftender points in internal pelvic floor muscles on standardized myofascial pelvic floor exam\n* Willing to refrain from new clinical treatments that may affect pain during the study period\n\nExclusion Criteria:\n\n* Inability to participate in clinic visits\n* Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacral neuromodulation, intradetrusor Botox®)\n* Active UTI or vaginal infection\n* Pregnancy, childbirth during the previous 12 months, currently planning pregnancy\n* Illicit Drug addiction\u002Fregular use of controlled substances\n* Malignancy or other serious medical condition (e.g., poorly controlled diabetes \\[HgA1c \\> 8\\], neurologic or rheumatic disease)\n* Diagnosed with an alternate cause of pelvic pain (e.g., interstitial cystitis, vestibulodynia, vulvar dermatoses dysmenorrhea)\n* Urinary retention\n* Greater than stage 3 pelvic organ prolapse\n* Indwelling vaginal devices (e.g., pessary, contraceptive ring)\n* Inability to sign an informed consent, fill out questionnaires, or complete study interviews",true,"FEMALE","18 Years",{"count":68,"type":69},110,"ESTIMATED","OBSERVATIONAL","Myofascial Pelvic Pain (MPP) is an often-misdiagnosed condition affecting up to 26% of women during their lives and imposing enormous costs on national health care systems. It frequently involves comorbidities such as bladder, bowel, and sexual dysfunction. There are no quantitative measures that adequately guide the physician and accurate diagnosis typically requires an internal examination by a tertiary specialist.\n\nThis study will develop and test an instrument to establish a normal range for near infrared spectroscopy (NIRS) optical changes associate with pelvic floor exercise in adult women based on the test-to test (intra-day) reliability of oxygen kinetics related to contraction of the pelvic floor muscle.\n\nWe will establish the relationship between the quantitative NIRS data, the condition of Myofascial pelvic musculature and the symptomatology of MPP and related comorbidities. We will also evaluate prospectively the effectiveness of these data in predicting effective treatment modalities. Finally, we will optimize a training regime for non-specialists to allow this technique to be used in a variety of settings.\n\nThe development of this device and validation of its relevance to diagnosis and treatment of MPP will provide effective care sooner and at a lower cost than current procedures. It will also reduce inequities in the availability of care to underserved populations by providing an inexpensive, reliable and easily available method for a variety of providers to address MPP.",[73],"Myofascial Pelvic Pain",[75],"pelvic pain","2025-09-18",{"date":78,"type":79},"2025-09-23","ACTUAL",{"date":81,"type":79},"2025-01-23",{"date":83,"type":69},"2026-09-01",{"name":5,"class":6},1]