NCT07195045|RecruitingDMC
Thai PainPREDICT Validation Study
PainPREDICT-Th
Thai Version of PainPREDICT: Translation, Validation, and Mobile Application Development for Screening Painful Diabetic Neuropathy in Diabetes Patients
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PainPREDICT-Th
Thai Version of PainPREDICT: Translation, Validation, and Mobile Application Development for Screening Painful Diabetic Neuropathy in Diabetes Patients
Sponsor study identifier
Secondary identifiers
OTHER · Institutional Review Board, Faculty of Medicine, Chulalongkorn University
interventional
277
1 country
1
Study Start
August 28, 2025
Actual (reported)Primary Completion
August 27, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2025
Actual (reported)September 19, 2025
Actual (reported)September 26, 2025
Actual (reported)August 27, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Reliability and Validity of Thai PainPREDICT Questionnaire
Reliability will be assessed by internal consistency (Cronbach's alpha) and test-retest intraclass correlation coefficients. Validity will be examined by correlation with other neuropathic pain questionnaires (DN4, NPSI), construct validity, and diagnostic performance (sensitivity, specificity, ROC AUC) compared with clinical diagnosis and neurophysiological testing.
Baseline through 12 months (Phases 1 and 2)
Usability of the Thai PainPREDICT Mobile Application
Months 7-15 (Phase 2)
Diagnostic Accuracy of Thai PainPREDICT Questionnaire in Clinical Setting
Months 16-26 (Phase 3)
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/or paper version. Results will be compared against clinical diagnosis and neurophysiological tests.
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/or paper version, with results compared against clinical assessment and neurophysiological testing.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
King Chulalongkorn Memorial hospital, The Thai Red Cross Society
Pathum Wan, Bangkok, 10330, Thailand
Jakkrit Amornvit, MD
King Chulalongkorn Memorial Hospital
First Submitted
September 19, 2025
First Posted
September 26, 2025
Contact the study team to confirm eligibility.
Study Start
August 28, 2025
Actual (reported)Primary Completion
August 27, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 3, 2025
Record last verified: 2025-09
Individual participant data (IPD) that underlie the results reported in this trial (after de-identification) will be made available to qualified researchers. This includes anonymized questionnaire data, clinical outcome measures, and diagnostic accuracy results. Neurophysiological raw data (e.g., NCS, QST) and laboratory results will also be included in de-identified form. Personal identifiers will be removed to comply with the Thai Personal Data Protection Act (PDPA 2019).
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Source: ClinicalTrials.gov.
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