[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659141":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":59,"studyPopulation":53,"armGroups":60,"interventions":71,"overallOfficials":77,"centralContacts":82,"locations":88,"responsibleParty":103,"collaborators":53,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":53,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":53,"enrollmentInfo":115,"targetDuration":53,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":137,"whyStopped":53,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Investigación en Hemofilia y Fisioterapia","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Change in pain interference from baseline to 6 months","Pain interference will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-Interference score is calculated as the mean of seven items scored from 0 to 10, with higher scores indicating greater interference of pain with daily life. The primary outcome is the between-group difference in mean change from baseline to the 6-month follow-up.","Baseline and 6 months",[14,18,22,25,28,31,34,37,40],{"measure":15,"description":16,"timeFrame":17},"Change in pain interference immediately after the intervention","BPI-Interference score, calculated as the mean of seven items scored from 0 to 10; higher scores indicate greater pain interference.","Baseline and immediately after Session 3",{"measure":19,"description":20,"timeFrame":21},"Change in pain intensity","Pain intensity will be assessed using the BPI-Severity subscale of the Brief Pain Inventory-Short Form, calculated from its four pain-intensity items. Higher scores indicate greater pain intensity.","Baseline, immediately after Session 3, and 6 months",{"measure":23,"description":24,"timeFrame":21},"Change in kinesiophobia","Kinesiophobia will be assessed using the Spanish version of the Tampa Scale for Kinesiophobia-11SV. Higher scores indicate greater fear of movement.",{"measure":26,"description":27,"timeFrame":21},"Change in pain catastrophising","Pain catastrophising will be assessed using the Spanish version of the Pain Catastrophizing Scale. Higher scores indicate greater pain catastrophising.",{"measure":29,"description":30,"timeFrame":21},"Change in health-related quality of life","Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The eight SF-36 domains and the physical and mental component summary scores will be analysed. Higher scores indicate better health-related quality of life.",{"measure":32,"description":33,"timeFrame":21},"Change in depressive symptoms","Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Higher scores indicate greater depressive symptom severity.",{"measure":35,"description":36,"timeFrame":21},"Change in anxiety","Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), comprising 20-item state-anxiety and 20-item trait-anxiety subscales. Higher scores indicate greater anxiety.",{"measure":38,"description":39,"timeFrame":21},"Change in illness perception","Illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ), which assesses cognitive and emotional representations of illness and perceived illness threat.",{"measure":41,"description":42,"timeFrame":21},"Change in physical activity","Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), with a 7-day recall period. Vigorous and moderate physical activity, walking and sedentary behaviour will be recorded according to the instrument scoring protocol.",[44],{"measure":45,"description":46,"timeFrame":47},"Bleeding episodes and adverse events","Bleeding episodes, clinically relevant increases in pain and adverse events reported by participants will be recorded throughout follow-up.","From baseline to the 6-month follow-up",{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":53,"timePerspective":53,"maskingInfo":54},"RANDOMIZED","PARALLEL","Participants will be individually randomised 1:1 to the experimental or control arm. The intervention will be delivered in group cohorts only in the experimental arm, resulting in a partially nested design.","TREATMENT",null,{"masking":55,"maskingDescription":56,"whoMasked":57},"SINGLE","Participants and intervention providers cannot be blinded because of the educational nature of the intervention. Outcome assessment will be performed by an assessor blinded to treatment allocation. The investigator responsible for the statistical analysis will also remain blinded to group allocation until completion of the primary analysis.",[58],"OUTCOMES_ASSESSOR","This is a superiority, individually randomised, partially nested controlled trial with two parallel groups and a 1:1 allocation ratio. Participants allocated to the experimental arm will receive a structured multicomponent pain self-management programme delivered in three educational cohorts of approximately 11-12 participants. The control group will continue with usual care during the 6-month study period.\n\nThe intervention will comprise three face-to-face sessions of approximately 60 minutes delivered at 3-4-week intervals. It will integrate education on pain neurobiology and modulation, emotional-regulation training and cognitive-behavioural coping strategies. Content will be specifically adapted to haemophilic arthropathy, including education on distinguishing persistent pain from symptoms suggestive of acute haemarthrosis and a standardised safety pathway for suspected bleeding.\n\nParticipants in the control group will continue routine haematological follow-up, prescribed haemostatic and analgesic treatment and their usual physical activity, exercise or physiotherapy. Following completion of the 6-month assessment, control participants will be offered the same multicomponent programme.\n\nOutcomes will be assessed at baseline, immediately after the third intervention session and at 6 months. The primary outcome will be pain interference assessed using the Brief Pain Inventory-Short Form. Secondary outcomes will include pain intensity, kinesiophobia, pain catastrophising, anxiety, depressive symptoms, illness perception, health-related quality of life and physical activity.",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Experimental group","EXPERIMENTAL","Participants will receive three face-to-face group sessions of approximately 60 minutes delivered at 3-4-week intervals over approximately 6-8 weeks. The programme integrates pain education, emotional-regulation training and cognitive-behavioural self-management strategies specifically adapted to adults with haemophilic arthropathy.",[66],"Other: Multicomponent pain self-management programme",{"label":68,"type":69,"description":70,"interventionNames":53},"No Intervention","NO_INTERVENTION","Participants will continue their usual care, including routine haematological follow-up, prescribed haemostatic and analgesic treatment and their usual physical activity, exercise or physiotherapy routines. They will not receive the structured pain self-management programme or its educational materials before completion of the 6-month follow-up. After the final 6-month assessment, they will be offered the same multicomponent programme as the experimental group.",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":53},"OTHER","Multicomponent pain self-management programme","The intervention comprises three structured face-to-face group sessions. Content includes pain neurobiology and modulation; distinctions between nociception, pain and tissue damage; biopsychosocial and fear-avoidance models; emotional regulation; diaphragmatic breathing; mindfulness; acceptance and resilience; physical activity; identification of maladaptive beliefs and cognitive distortions; cognitive restructuring; self-instruction; guided imagery; physiological de-arousal; and development of an individual self-management plan. Participants will also receive digital educational materials and between-session home assignments. A standardised safety pathway for suspected acute haemarthrosis will be included.",[62],[78],{"name":79,"affiliation":80,"role":81},"Ruben C Cuesta-Barriuso, PhD","Universidad de Oviedo","STUDY_CHAIR",[83],{"name":84,"role":85,"phone":86,"phoneExt":53,"email":87},"Rubén Cuesta-Barriuso, PhD","CONTACT","0034 985103386","cuestaruben@uniovi.es",[89],{"facility":90,"status":53,"city":91,"state":53,"zip":53,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Spanish Federation of Haemophilia","Madrid","Spain","ES",{"type":95,"coordinates":96},"Point",[97,98],-3.70256,40.4165,{"lat":98,"lon":97},[101],{"name":84,"role":85,"phone":102,"phoneExt":53,"email":87},"0034 985 103 386",{"type":104,"investigatorFullName":105,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"PRINCIPAL_INVESTIGATOR","Rubén Cuesta-Barriuso","100659141","multicomponent-pain-self-management-in-adults-with-haemophilic-arthropathy-100659141",false,"NCT07860632","Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy","Multicomponent Pain Self-Management Programme in Adults With Haemophilic Arthropathy: Protocol for a Randomised Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of haemophilia A or B.\n* Haemophilic arthropathy previously diagnosed and documented by the participant's haemophilia treatment centre.\n* Persistent or recurrent pain for at least 3 months in one or more affected joints.\n* Sufficient capacity to understand the programme content, follow study instructions and complete the assessment instruments.\n* Ability to provide written informed consent.\n* Sufficient understanding of Spanish to complete the study procedures and questionnaires.\n\nExclusion Criteria:\n\n* Neurological or cognitive impairment that interferes with understanding of the intervention or completion of assessments.\n* Musculoskeletal surgery within the 2 months preceding inclusion.\n* Acute bleeding episode or acute musculoskeletal event within the 4 weeks preceding baseline assessment that would preclude valid completion of the assessment.\n* Concurrent participation in another structured educational or psychological intervention programme specifically targeting pain.\n* Insufficient understanding of Spanish to complete the study questionnaires.","MALE","18 Years",{"count":116,"type":117},70,"ESTIMATED","INTERVENTIONAL",[120],"NA","Background: Haemophilic arthropathy is associated with chronic pain, functional limitation and impaired quality of life. Pain interference may also be influenced by cognitive, emotional and behavioural factors. Evidence for structured multicomponent pain self-management programmes specifically tailored to adults with haemophilic arthropathy remains limited.\n\nObjective: To evaluate the effectiveness of a structured multicomponent pain self-management programme, compared with usual care, in reducing pain interference in adults with haemophilia A or B, haemophilic arthropathy and chronic pain.\n\nMethods: Approximately 70 adults will be individually randomised in a 1:1 ratio to a multicomponent pain self-management programme or usual care. The intervention will comprise three 60-minute face-to-face group sessions delivered over approximately 6-8 weeks. The programme will integrate pain education, emotional-regulation training and cognitive-behavioural self-management strategies. Assessments will be performed at baseline, immediately after the intervention and at 6 months. The primary outcome will be the between-group difference in change in Brief Pain Inventory-Interference score from baseline to 6 months.",[123,124,125,126],"Hemophilic Arthropathy","Chronic Pain","Hemophilia A","Hemophilia B",[128,129,130,131,132,133,134,135,136],"Hemophilic arthropathy","Chronic pain","Pain interference","Pain self-management","Pain neuroscience education","Kinesiophobia","Pain catastrophizing","Cognitive-behavioral therapy","Physiotherapy","NOT_YET_RECRUITING","2026-10-01",{"date":140,"type":141},"2026-10-06","ACTUAL",{"date":143,"type":117},"2027-03-01",{"date":145,"type":117},"2027-12-30",{"name":5,"class":6},1]