[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566825":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":57,"locations":66,"responsibleParty":100,"collaborators":103,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":42,"enrollmentInfo":122,"targetDuration":42,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":69,"whyStopped":42,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of Ottawa","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Sham laser","SHAM_COMPARATOR","15 treatments will be provided over a 14 week period but at an intensity of 1% output for all sites and at all stages. Each treatment will last approximately 20 minutes. At each visit, the array will be applied to the surface of the perineum (red and infrared light), followed by treatment at specific painful sites using the red light probe.",[13],"Device: Sham photobiomodulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Real laser","ACTIVE_COMPARATOR","15 treatments will be provided over a 14 week period. Each treatment will last approximately 20 minutes and will include the laser array first being applied to the surface of the perineum (red and infrared light) and the focal probe will be applied to painful sites on the perineum. All the stages will involve use of the same array and probe placement, but at each stage the dosage will be increased according to the BioFlex protocol.",[19],"Device: Photobiomodulation",{"label":21,"type":16,"description":22,"interventionNames":23},"Sham laser + multi-modal physiotherapy","Over 14 weeks, participants will receive 10 physiotherapy sessions and 15 sham laser sessions, lasting a total of 50 minutes. Laser and physiotherapy treatments will be delivered within the same visit where possible. For the physiotherapy, the therapist will start with education, followed by progressive relaxation exercises and deep breathing. Participants will practice graded pelvic floor muscle (PFM) contractions, manual stretching techniques with external palpation, and gradually progressing to the insertion of one or two fingers into the vagina. Finally, vaginal dilators will be used to stretch the vaginal opening and PFMs. The participant will use relaxation breathing and contraction\u002Frelaxation cycles to facilitate insertion, progressing to larger dilators as tolerated. For the sham laser, the same protocol will be followed as described in previous arms.",[13,24],"Procedure: Multimodal physiotherapy",{"label":26,"type":27,"description":28,"interventionNames":29},"Laser + multi-modal physiotherapy","EXPERIMENTAL","This treatment group will receive a combination therapy (i.e., both laser and physiotherapy), with each session lasting up to 50 minutes over a 14 week period. Laser and physiotherapy treatments will be delivered within the same visit where possible. Laser and physiotherapy protocols will be delivered as described in the previous arms.",[19,24],[31,38,43],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Photobiomodulation","The laser therapy will be delivered in progressively higher doses, based on individual participants. Each stage will follow this sequence of applications: (1) perineum application (DUO-240 red and infrared array in the surface of the perineum) and (2) LDR-100 probe on the vestibula more generally. Doses will increase from 40%-100% power over the course of the intervention",[26,15],[37],"Low level laser therapy",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Sham photobiomodulation","The laser therapy will be delivered in progressively higher doses, based on individual participants tolerance. Each stage will follow this sequence of applications: (1) perineum application (DUO-240 red and infrared array in the surface of the perineum) and (2) LDR-100 probe on the vestibula more generally. . Doses will always be set to 1% power over the course of the intervention",[9,21],null,{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"PROCEDURE","Multimodal physiotherapy","A total of 10 sessions of multimodal physiotherapy interventions will be provided to each of the participants in the multimodal physiotherapy (mPT) and multimodal physiotherapy combined with photobiomodulation treatment (mPT+PBM) groups. In general, each session will take place in the following order:1) Subjective assessment of the condition and screening for adverse effects or deterioration of the condition, 2)Education, 3) Relaxation Techniques, 4) Pelvic Floor Muscle Exercises, 5) Manual techniques, 6) exercises with accommodators, 7) Global exercises, 8) Assessment of the post-treatment condition and 9) adjustment of the weekly exercise program to be done at home. Each of these 9 treatments will be adjusted and tailored to each participant and progressed based on individual preference and response to treatment under the discretion of the study physiotherapist.",[26,21],[49],"Physiotherapy",[51,54],{"name":52,"affiliation":5,"role":53},"Linda McLean, PhD","PRINCIPAL_INVESTIGATOR",{"name":55,"affiliation":56,"role":53},"Stephanie Bernard, PhD","University of Laval",[58,63],{"name":52,"role":59,"phone":60,"phoneExt":61,"email":62},"CONTACT","613-562-5800","4102","Linda.Mclean@uottawa.ca",{"name":64,"role":59,"phone":60,"phoneExt":61,"email":65},"Regina Ding, PhD","rding@uottawa.ca",[67,87],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Motor Function Measurement Lab","RECRUITING","Ottawa","Ontario","K1S 1S2","Canada","CA",{"type":76,"coordinates":77},"Point",[78,79],-75.69812,45.41117,{"lat":79,"lon":78},[82],{"name":83,"role":59,"phone":84,"phoneExt":85,"email":86},"Lina McLean, PhD","(613) 562-5800","2544","lmclea2@uottawa.ca",{"facility":88,"status":69,"city":89,"state":90,"zip":42,"country":73,"countryCode":74,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Bernard Lab","Québec","Quebec",{"type":76,"coordinates":92},[93,94],-71.21454,46.81228,{"lat":94,"lon":93},[97],{"name":55,"role":59,"phone":98,"phoneExt":42,"email":99},"418 656-2131","stephanie.bernard@fmed.ulaval.ca",{"type":53,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Dr. Linda McLean","Professor",[104,107,110],{"name":105,"class":106},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":108,"class":109},"University of Laval, Quebec City, Canada","UNKNOWN",{"name":111,"class":109},"BioFlexTM Laser Therapy","100566825","biomodulation-and-rehabilitation-interventions-to-target-pelvic-health-100566825",false,"NCT06660212","Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health","Is Multimodal Physiotherapy and\u002For Photobiomodulation Therapy Effective for Pain Reduction Among Those Who Experience Provoked Vestibulodynia: a Randomized Controlled Trial","BRIGHT","Inclusion Criteria:\n\n* Willing to travel to Ottawa area or Quebec City area\n* Biologically born female older than eighteen years\n* Pre-menopausal\n* Not currently pregnant or pregnancy\u002Fgiven birth in the past six months\n* Experiencing signs and symptoms consistent with provoked vestibulodynia alone or provoked vestibulodynia plus vaginismus\n\nExclusion Criteria:\n\n* gynaecologist cannot insert a single digit intravaginally and thus the participant would be unlikely able to tolerate the assessment procedures\n* other gynaecologic conditions such as lichen sclerosus, fissures, endometriosis, adenomyosis, or pelvic organ prolapse","FEMALE","18 Years",{"count":123,"type":124},240,"ESTIMATED","INTERVENTIONAL",[127],"NA","This trial will provide evidence for the effective management of pain and pain-related domains among those who experience provoked vestibulodynia (PVD) using photobiomodulation (PBM) and multimodal physiotherapy (mPT) in a randomized controlled trial (RCT). PVD is the most common subcategory of vulvovaginal pain experienced during sexual and non-sexual activities, affects the psychological and sexual health of an astounding one in five Canadian women, yet access to evidence-informed management approaches is limited. We will employ four intervention groups: PBM, sham PBM (control), PBM combined with mPT, and mPT with sham PBM to evaluate the effectiveness of each approach on its own and the two approaches in combination.\n\nAmong those who experience PVD, we seek to answer:\n\n1. Relative to baseline and to sham PBM, does a 14-week intervention involving PBM, mPT, or a combination of mPT and PMB reduce vulvar pain severity reported on the Vulvar Pain Assessment Questionnaire (VPAQ)?\n2. Is a combined mPT and PBM intervention more effective than mPT or PMB alone when considering vulvar pain severity and\u002For related domains as measured through VPAQ?\n3. Are positive changes in vulvar pain severity and related domains observed following a 14-week intervention involving PBM, mPT or a combination of PBM and mPT retained at 6 months and at 1 year?\n\nSecondary objectives include determining the effectiveness of PBM, mPT, and mPT combined with PBM relative to sham PBM on: Patient Global Impression of Change (PGIC), pain sensitivity measured using provocative tests, the other domains of the VPAQ, sexual function, as well as investigating mediating effects of psychosocial variables (central sensitization index, chronic pain acceptance), gender identity, and the presence of vaginismus on patient response to mPT, PBM and mPT combined with PBM. Lastly we will monitor patient satisfaction with the interventions, adherence to the interventions, and any adverse events.",[130,131,132],"Vulvodynia","Provoked Vestibulodynia","Dyspareunia",[134,135,130,136,137,138,139],"Provoked vestibulodynia","Intervention","Double-blinded","Pelvic floor","laser","Vulvar pain","2026-04-28",{"date":142,"type":143},"2026-05-05","ACTUAL",{"date":145,"type":143},"2025-03-17",{"date":147,"type":124},"2028-11",{"name":5,"class":6},2]