[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657511":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":49,"armGroups":59,"interventions":73,"overallOfficials":49,"centralContacts":49,"locations":86,"responsibleParty":110,"collaborators":49,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":49,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":49,"enrollmentInfo":123,"targetDuration":49,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":136,"overallStatus":89,"whyStopped":49,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Hacettepe University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Bladder-Related Pain Severity","Bladder-related pain severity will be assessed using a 10-cm Visual Analog Scale. Participants will be asked to mark the point that best represents the most severe bladder-related pain or pain-like discomfort, such as burning, pressure, or discomfort, experienced during the last three days. Scores range from 0 to 10, with higher scores indicating greater pain severity.","Baseline and 8 weeks",[14,17,20,23,26,29,32,35,38,42,46],{"measure":15,"description":16,"timeFrame":12},"Change in Bladder Pain Syndrome-Related Symptom Severity","Bladder pain syndrome-related symptom severity will be assessed using the Interstitial Cystitis Symptom Index. The index consists of 4 items assessing urinary urgency, urinary frequency, nocturia, and bladder pain or burning. Total scores range from 0 to 20, with higher scores indicating greater bladder pain syndrome-related symptom severity.",{"measure":18,"description":19,"timeFrame":12},"Change in Bladder Pain Syndrome-Related Problem Severity","Bladder pain syndrome-related problem severity will be assessed using the Interstitial Cystitis Problem Index. The index consists of 4 items assessing the extent to which urinary frequency, nocturia, urinary urgency, and bladder pain or burning are experienced as problems. Total scores range from 0 to 16, with higher scores indicating greater bladder pain syndrome-related problem severity.",{"measure":21,"description":22,"timeFrame":12},"Change in Pressure Pain Threshold","Pressure pain threshold will be assessed using a digital pressure algometer over the suprapubic region, peroneal region, and ulnar surface of the forearm. The value at which the participant first perceives the applied pressure as painful will be recorded. Three measurements will be taken from each site.",{"measure":24,"description":25,"timeFrame":12},"Change in Conditioned Pain Modulation","Conditioned pain modulation will be assessed using pressure pain threshold measurement over the upper trapezius muscle as the test stimulus and a cuff pressure test applied to the contralateral upper extremity as the conditioning stimulus. Pressure pain threshold will be measured before and immediately after the conditioning stimulus.",{"measure":27,"description":28,"timeFrame":12},"Change in Central Sensitization-Related Symptoms","Central sensitization-related symptoms will be assessed using the Central Sensitization Inventory. The scale includes 25 items related to symptoms such as pain, fatigue, sleep disturbance, cognitive complaints, and emotional symptoms. Total scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom burden.",{"measure":30,"description":31,"timeFrame":12},"Change in Anxiety and Depression Symptoms","Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale. The scale consists of 14 items and includes two 7-item subscales evaluating anxiety and depression. Scores for each subscale range from 0 to 21, with higher scores indicating greater anxiety or depression symptom severity.",{"measure":33,"description":34,"timeFrame":12},"Change in Functional Exercise Capacity","Functional exercise capacity will be assessed using the 6-Minute Walk Test. Participants will be asked to walk as far as possible without running for 6 minutes in a suitable corridor. The total distance walked will be recorded in meters.",{"measure":36,"description":37,"timeFrame":12},"Change in Health-Related Quality of Life","Health-related quality of life will be assessed using the 12-Item Short Form Health Survey. The questionnaire yields Physical Component Summary and Mental Component Summary scores. Each score ranges from 0 to 100, with higher scores indicating better physical or mental health-related quality of life.",{"measure":39,"description":40,"timeFrame":41},"Subjective Perception of Change in Bladder-Related Pain Symptoms","Participants' perceived change in bladder-related pain symptoms compared with the beginning of treatment will be assessed using a 7-point subjective perception of change scale. Scores range from 1 to 7, where 1 indicates markedly worse, 4 indicates no change, and 7 indicates markedly improved. Higher scores indicate greater perceived improvement.","At 8 weeks",{"measure":43,"description":44,"timeFrame":45},"Adherence to Exercise and Intervention","Adherence to the intervention will be assessed based on attendance at clinical sessions and continuation of out-of-clinic aerobic exercises. Attendance at clinical sessions will be recorded after each session. Adherence to out-of-clinic aerobic exercises will be monitored using exercise diaries kept by participants and the physiotherapist, and adherence will be calculated as a percentage.","During the 8-week intervention period",{"measure":47,"description":48,"timeFrame":41},"Adherence to Lifestyle Recommendations","Adherence to lifestyle recommendations will be assessed using a Numeric Rating Scale. Participants will be asked to rate their overall adherence to the lifestyle recommendations on a scale from 0 to 10, where 0 indicates no adherence and 10 indicates complete adherence.",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":55,"maskingDescription":56,"whoMasked":57},"SINGLE","Outcome assessments will be performed by an assessor who is blinded to group allocation. Due to the nature of the physiotherapy interventions, participants and the care provider delivering the intervention cannot be blinded.",[58],"OUTCOMES_ASSESSOR",[60,68],{"label":61,"type":62,"description":63,"interventionNames":64},"Patient Education + Multimodal Physiotherapy","EXPERIMENTAL","Participants in this group will receive patient education together with an 8-week multimodal physiotherapy program including aerobic exercise training and connective tissue massage. The interventions will be delivered according to the planned protocol. Each session will last approximately 70 to 75 minutes.",[65,66,67],"Behavioral: Patient Education","Behavioral: Aerobic Exercise Training","Other: Connective Tissue Massage",{"label":69,"type":70,"description":71,"interventionNames":72},"Patient Education","ACTIVE_COMPARATOR","Participants in this group will receive patient education alone. During the study period, participants will be followed at regular two-week intervals. During these follow-ups, symptom status will be checked and brief reminders about lifestyle and symptom management recommendations provided during patient education will be given.",[65],[74,78,82],{"type":75,"name":69,"description":76,"armGroupLabels":77,"otherNames":49},"BEHAVIORAL","Participants will receive patient education about bladder pain syndrome, symptom management, lifestyle recommendations, and strategies to support self-management. This intervention will be provided to both study groups.",[69,61],{"type":75,"name":79,"description":80,"armGroupLabels":81,"otherNames":49},"Aerobic Exercise Training","Participants in the intervention group will receive an 8-week aerobic exercise training program in addition to patient education.",[61],{"type":6,"name":83,"description":84,"armGroupLabels":85,"otherNames":49},"Connective Tissue Massage","Participants in the intervention group will receive connective tissue massage in addition to patient education and aerobic exercise training. The intervention will be delivered by a physiotherapist according to the study protocol as part of the 8-week multimodal physiotherapy program.",[61],[87],{"facility":88,"status":89,"city":90,"state":90,"zip":49,"country":91,"countryCode":49,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Hacettepe University Faculty of Physical Therapy and Rehabilitation","RECRUITING","Ankara","Turkey (Türkiye)",{"type":93,"coordinates":94},"Point",[95,96],32.85427,39.91987,{"lat":96,"lon":95},[99,105,108],{"name":100,"role":101,"phone":102,"phoneExt":103,"email":104},"Serap Ozgul, Prof. Dr.","CONTACT","+90 312 305 25 25","173","serapky@yahoo.com",{"name":106,"role":101,"phone":49,"phoneExt":49,"email":107},"Hilal Yazici Ilhan, Research Assistant","hilalyazici@hacettepe.edu.tr",{"name":106,"role":109,"phone":49,"phoneExt":49,"email":49},"SUB_INVESTIGATOR",{"type":111,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"PRINCIPAL_INVESTIGATOR","SERAP ÖZGÜL","Prof. Dr.","100657511","aerobic-exercise-and-connective-tissue-massage-in-painful-bladder-syndrome-100657511",false,"NCT07839689","Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome","Effects of Aerobic Exercise Training and Connective Tissue Massage in Individuals With Bladder Pain Syndrome","Inclusion Criteria:\n\n* Female individuals aged 18 years or older\n* Diagnosis of bladder pain syndrome\n* Bladder-related pain, discomfort, and\u002For burning symptoms lasting for at least 6 months\n* Bladder-related symptom severity, including pain, discomfort, and\u002For burning, of at least 3 cm on the Visual Analog Scale during the last week\n* Receiving stable medical treatment\n* Being medically suitable for moderate-intensity aerobic exercise according to the Physical Activity Readiness Questionnaire\n* Volunteering to participate in the study and signing the informed consent form\n* For individuals aged 65 years or older, a Mini-Mental State Examination score of 24 or higher\n\nExclusion Criteria:\n\n* Presence of acute urinary tract or urogynecological infection\n* Pregnancy and\u002For breastfeeding\n* Diagnosis of pelvic, urological, and\u002For gynecological malignancy or history of pelvic radiotherapy\n* Pelvic or abdominal surgery within the last 6 months\n* Presence of congenital urinary system anomalies\n* History of neurological disease or diagnosis of neurogenic bladder\n* Open wound or active skin infection in the area where manual therapy will be applied","FEMALE","18 Years",{"count":124,"type":125},36,"ESTIMATED","INTERVENTIONAL",[128],"NA","The goal of this clinical trial is to learn if aerobic exercise training and connective tissue massage, in addition to patient education, can help treat women with bladder pain syndrome. The main questions it aims to answer are:\n\nDoes aerobic exercise training and connective tissue massage reduce bladder-related pain severity?\n\nDoes this intervention improve urinary symptoms, pain sensitivity, central sensitization-related symptoms, psychological symptoms, and quality of life?\n\nResearchers will compare patient education plus aerobic exercise training and connective tissue massage with patient education alone to see if the combined physiotherapy program is more effective.\n\nParticipants will:\n\nReceive patient education about bladder pain syndrome\n\nBe randomly assigned to one of two groups\n\nReceive either patient education alone or patient education together with aerobic exercise training and connective tissue massage for 8 weeks\n\nComplete assessments at the beginning of the study and after 8 weeks",[131,132,133,134,135],"Bladder Pain Syndrome","Painful Bladder Syndrome","Painful Bladder Syndrome (PBS)","Interstitial Cystitis and Bladder Pain Syndrome","Interstitial Cystitis\u002FPainful Bladder Syndrome",[137,83,131,138,139],"aerobic exercises","Interstitial Cystitis","Physiotherapy","2026-09-23",{"date":142,"type":143},"2026-09-24","ACTUAL",{"date":145,"type":143},"2026-04-30",{"date":147,"type":125},"2029-04-30",{"name":5,"class":6},1]