[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607937":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":37,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":37,"enrollmentInfo":72,"targetDuration":37,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":86,"overallStatus":45,"whyStopped":37,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Chulalongkorn University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Painful Diabetic Neuropathy (PDN) Group","EXPERIMENTAL","Adults with type 1 or type 2 diabetes who have painful diabetic neuropathy, confirmed by clinical assessment. Participants will complete the Thai PainPREDICT questionnaire via the mobile application and\u002For paper version. Results will be compared against clinical diagnosis and neurophysiological tests.",[13],"Diagnostic Test: Thai PainPREDICT Questionnaire and Mobile Application",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Non-PDN Diabetic Control Group","ACTIVE_COMPARATOR","Adults with type 1 or type 2 diabetes without painful neuropathy, matched by age, sex, and diabetes type. Participants will complete the Thai PainPREDICT questionnaire via the mobile application and\u002For paper version, with results compared against clinical assessment and neurophysiological testing.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Thai PainPREDICT Questionnaire and Mobile Application","The Thai PainPREDICT Questionnaire is a culturally adapted and validated version of an internationally recognized neuropathic pain assessment tool. In this study, it is administered via both paper form and a secure mobile application designed for Thai patients with diabetes. The app automates scoring, provides real-time feedback, and securely stores data in REDCap in compliance with Thai Personal Data Protection Act (PDPA). The intervention is used to screen for painful diabetic neuropathy and compare results against clinical diagnosis and neurophysiological testing, including DN4, nerve conduction studies, and quantitative sensory testing.",[9,15],[26,27],"PainPREDICT (Thai Version)","PainPREDICT App",[29],{"name":30,"affiliation":31,"role":32},"Jakkrit Amornvit, MD","King Chulalongkorn Memorial Hospital","PRINCIPAL_INVESTIGATOR",[34,39],{"name":30,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","+66622169338",null,"jakkrit.a@chula.ac.th",{"name":40,"role":35,"phone":36,"phoneExt":37,"email":41},"Tharadon Deepracha, MSc","tharadon.d@chulahospital.org",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"King Chulalongkorn Memorial hospital, The Thai Red Cross Society","RECRUITING","Pathum Wan","Bangkok","10330","Thailand","TH",{"type":52,"coordinates":53},"Point",[54,55],100.52329,13.73698,{"lat":55,"lon":54},[58],{"name":30,"role":35,"phone":36,"phoneExt":37,"email":38},{"type":32,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Jakkrit Amornvit, MD.","Priciple Investigator","100607937","thai-painpredict-validation-study-100607937",false,"NCT07195045","Thai PainPREDICT Validation Study","Thai Version of PainPREDICT: Translation, Validation, and Mobile Application Development for Screening Painful Diabetic Neuropathy in Diabetes Patients","PainPREDICT-Th","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosed with type 1 diabetes mellitus or type 2 diabetes mellitus.\n* Able to communicate in Thai.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of neuropathy due to other causes (e.g., alcohol, chemotherapy, HIV, other systemic diseases).\n* Significant cognitive impairment or neurological conditions that prevent comprehension of the questionnaire.\n* Severe psychiatric illness that interferes with study participation.","ALL","18 Years",{"count":73,"type":74},277,"ESTIMATED","INTERVENTIONAL",[77],"NA","Painful diabetic neuropathy (PDN) is one of the most common and disabling complications of diabetes mellitus, substantially affecting quality of life, daily functioning, and health system burden. Early identification of PDN is crucial for timely treatment, prevention of complications such as foot ulcers and amputations, and for reducing healthcare costs. However, in Thailand there are limited culturally adapted and validated tools for screening PDN. PainPREDICT is an internationally validated questionnaire designed to characterize neuropathic pain profiles, but its adaptation for Thai patients has not yet been undertaken. In parallel, the use of mobile health technologies (mHealth) has the potential to expand access to screening and monitoring of chronic conditions, particularly in resource-limited settings.",[80,81,82,83,84,85],"Painful Diabetic Neuropathy (PDN)","Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)","Type 1 Diabetes Mellitus (T1DM)","Type 2 Diabetes Mellitus (T2DM)","Neuropathic Pain","Diabetes Complications",[87,88,89,90,91,92,93,94,95,96,85,97],"PainPREDICT","Painful Diabetic Neuropathy","Diabetic Neuropathy","Neuropathic Pain Questionnaire","Mobile Health (mHealth)","Questionnaire Validation","Screening Tool","Thai Population","Cross-Cultural Adaptation","Digital Health Application","Neuropathy Screening","2025-09-29",{"date":100,"type":101},"2025-10-03","ACTUAL",{"date":103,"type":101},"2025-08-28",{"date":105,"type":74},"2027-12-31",{"name":5,"class":6},1]