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.
Adults aged 18 years or older.
Diagnosed with type 1 diabetes mellitus or type 2 diabetes mellitus.
Able to communicate in Thai.
Willing and able to provide written informed consent.
Presence of neuropathy due to other causes (e.g., alcohol, chemotherapy, HIV, other systemic diseases).
Significant cognitive impairment or neurological conditions that prevent comprehension of the questionnaire.
Severe psychiatric illness that interferes with study participation.
Parallel
Thai PainPREDICT Questionnaire and Mobile Application
Diagnostic testThe 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.
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.
Usability of the Thai PainPREDICT Mobile Application
System Usability Scale (SUS) score and qualitative interviews with clinicians and patients to assess ease of use, clarity, efficiency, and satisfaction with the application.
Diagnostic Accuracy of Thai PainPREDICT Questionnaire in Clinical Setting
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and ROC AUC of the Thai PainPREDICT questionnaire administered via the mobile application compared with physician diagnosis and neurophysiological tests (NCS, QST).
Click on the lead sponsor to view all of their trials.
