[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053243":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":66,"collaborators":10,"id":68,"slug":10,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":10,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pelvic pain",null,"Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and\u002For treatment",[13,14,15,16],"Other: Psychophysical assessment","Behavioral: Psychophysical assessments of experimental pain","Diagnostic Test: Blood, urine and saliva samples","Procedure: Biopsy and surgery-related data.",[18,22,27,32],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"Psychophysical assessment","Thermal stimuli: The Thermal Sensory Analyzer will be used to deliver heat and cold stimuli. All targeted stimulus temperatures will be less than 50°C, and participants will be free to remove their arm or leg at any time from the thermode. Noxious cold stimuli will also be delivered with a plastic water bath or an electronic electronic temperature-controlled water bath. Participants will be free to pull out of the water bath at any time.\n\nPressure stimuli: Pressure stimuli will be applied by using a handheld algometer. These devices have a round probe that allows quantifying the amount of pressure that is being applied by real-time visual feedback to control and monitor applied pressure rates. Pressure will be applied to the lower leg, volar forearm, or trapezius.\n\nMechanical stimuli: A set of standardised von Frey filaments (0.25, 0.5, 1, 2, 4, 8, 16, 32, 64, 128 and 256mN). The contact area of the hairs with the skin is of uniform size (\\\u003C1 mm²) and texture.",[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"BEHAVIORAL","Psychophysical assessments of experimental pain","Pain ratings- Pain intensity and pain unpleasantness ratings will be assessed\n\nPain thresholds to heat, cold and\u002For pressure will be tested and participants will be instructed to press a button the first moment they feel pain.\n\nTemporal summation- participants will rate the pain evoked by a single pinprick stimulus and by a series of 10 identical pinprick stimuli.\n\nConditioned pain modulation (CPM) efficiency - CPM testing includes the application of a \"test\" stimulus without conditioning (heat or pressure stimuli) and a subsequent application of the same test stimulus together with a conditioning stimulus (cold stimulus).\n\nOffset analgesia will be assessed using the three-temperature method (T1°C 5s, T1+1°C 5s, T1°C 20s). During the OA paradigm, real time pain intensity ratings will be obtained\n\nCold pain tolerance will be assessed by having participants immerse their hand or foot in a cold water bath. Tolerance will be defined by the time of hand\u002Ffoot withdrawal.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DIAGNOSTIC_TEST","Blood, urine and saliva samples","Blood (approximately 2 tablespoons), urine and saliva samples will be collected and sent to ZRT Laboratory, LabCorp, or internal Washington University lab for analyses of sex hormone levels (e.g., testosterone, estradiol, progesterone). Additional samples will be stored in a biobank for future processing.",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"PROCEDURE","Biopsy and surgery-related data.","During the surgery, biopsies will be collected from the endometriosis lesions as well as from a healthy peritoneum. If there are no endometriosis lesions, biopsies will be taken of two common locations where endometriosis lesion grows (the infra-ovarian fossa). The lesions will be characterized based on their appearance and invasiveness of the lesions (i.e., powder-burn lesions, nonclassical red or white lesions, and superficially or deeply infiltrating (\\>5mm) lesions). In addition, surgery-related data such as the incision size, type of anesthesia, pain ratings after the surgery, analgesic medication after the surgery, and side effects will be documented. Blood, saliva, urine, and samples will be collected for hormonal analyses or stored in a Biobank for future analyses.",[9],[38],{"name":39,"affiliation":5,"role":40},"Hadas Nahman-Averbuch, PhD","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Alana McMichael, MA","CONTACT","314-273-6194","painlab@wustl.edu",{"name":48,"role":44,"phone":45,"phoneExt":10,"email":10},"Hadas Nahman-Averbuch",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","St Louis","Missouri","63110","United States",{"type":57,"coordinates":58},"Point",[59,60],-90.19789,38.62727,{"lat":60,"lon":59},[63,64,65],{"name":39,"role":44,"phone":45,"phoneExt":10,"email":46},{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},{"name":39,"role":40,"phone":10,"phoneExt":10,"email":10},{"type":40,"investigatorFullName":48,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Asst Prof of Anesthesiology","100053243",false,"NCT06101303","Endometriosis Pain","The Mechanisms Underlying Endometriosis Pain","Inclusion criteria:\n\n* Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and\u002For treatment\n* Age 12-45\n* Females\n\nExclusion criteria:\n\n* Pregnancy\n* Planned hysterectomy or oophorectomy\n* Co-occurring vaginismus and\u002For vulvodynia\n* For patients aged 12-17 not having a parent\u002Flegal guardian willing to sign the consent and answer surveys about their child's health","FEMALE","12 Years","45 Years",{"count":78,"type":79},120,"ESTIMATED","OBSERVATIONAL","Aim 1. To determine the factors contributing to pain in patients with chronic pelvic pain with and without endometriosis Aim 2. To determine the changes following endometriosis lesion removal surgery in pain and sex hormone levels.\n\nAim 3. To identify factors predicting clinical pain reduction after lesion removal surgery.\n\nAdditional exploratory aims might compare subgroups of patients such as patients with vs. without endometriosis, with vs. without additional chronic pain syndromes, and with vs. without hormonal treatment. In addition, the role of lesion-specific immune signatures and psychological factors on pain will be explored.\n\nPatients with pelvic pain potentially due to endometriosis will complete questionnaires including social, health, behavioral, and psychological questionnaires. Patients will also complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. In addition, blood, urine, and saliva samples will be collected for hormonal, immune, and genetic analyses. Additional samples might be collected and stored for future analyses. For some participants, these procedures will be completed several times, including before the surgery as well as 3 months, 6 months and 1 year after surgery. After the surgery, surveys assessing pain and other symptoms will be sent every week on the first month and then monthly for 1 year. In addition, during the surgery, biopsies will be collected and analyzed to determine hormonal, immune and genetic factors.\n\nFor adolescents, a parent\u002Flegal guardian will be asked to assist in completing some of the health-related surveys (i.e., physical developmental survey, health survey, migraine history survey).",[83,84],"Pelvic Pain","Endometriosis","2026-07-10",{"date":87,"type":88},"2026-07-13","ACTUAL",{"date":90,"type":88},"2023-09-29",{"date":92,"type":79},"2029-09-01",{"name":5,"class":6},1]