Thai PainPREDICT Mobile App: Digital Screening for Diabetic Nerve Pain

This clinical trial focuses on developing a culturally adapted Thai version of the PainPREDICT questionnaire and integrating it into a mobile application to improve screening for painful diabetic neuropathy (PDN) in Thailand. Painful diabetic neuropathy is a common and debilitating complication affecting up to 50% of people with diabetes, characterized by chronic pain, numbness, tingling, or burning sensations, primarily in the hands and feet. Beyond physical discomfort, PDN significantly impacts sleep, mobility, mental health, and overall quality of life, while increasing the risk of serious complications like foot ulcers and amputations.

The study is crucial because PDN is vastly underdiagnosed in many healthcare settings, including Thailand. This is often due to a lack of awareness, limited specialist access, especially in rural areas, and the absence of simple, validated screening tools tailored to the local language and culture. The original PainPREDICT tool was developed in Western countries and has shown high accuracy in identifying neuropathic pain mechanisms and predicting treatment responses. However, a direct translation is not sufficient; it requires careful cultural adaptation to ensure questions are understood correctly and are relevant to Thai patients.

The research will be conducted in three main phases over 30 months. The first phase involves translating the questionnaire into Thai using a rigorous forward-backward translation process by bilingual experts. It will then be tested for clarity and cultural appropriateness with a small group of patients. The reliability and validity of the Thai version will be assessed in 50 participants with diabetes, comparing its results against established diagnostic tools and objective nerve tests.

The second phase is dedicated to developing a user-friendly mobile application that incorporates the validated Thai PainPREDICT questionnaire. This app will allow patients to complete the screening easily, provide instant feedback, and securely store their data. The development process will include alpha and beta testing with both clinicians and patients to ensure the app is intuitive, efficient, and meets the needs of its users. Usability will be measured using standardized scales and interviews.

In the third and largest phase, the mobile application will be evaluated in a clinical setting with approximately 277 adults diagnosed with type 1 or type 2 diabetes. Participants will be divided into two groups: those with confirmed painful diabetic neuropathy and a control group without neuropathy. All participants will use the app to complete the questionnaire, and the results will be compared against gold-standard clinical diagnoses and neurophysiological tests like nerve conduction studies. This will determine the app's diagnostic accuracy, including its sensitivity and specificity for correctly identifying PDN. A special focus will be placed on assessing the app's effectiveness in resource-limited clinics, with the goal of reducing delays in diagnosis and improving access to care.

The potential benefits of this research are significant for patients and the healthcare system in Thailand. It aims to provide a simple, accessible, and accurate tool for the early detection of painful diabetic neuropathy. Early identification is key to managing symptoms effectively, preventing complications, and improving a patient's quality of life. For caregivers, a reliable screening tool can offer peace of mind and help in advocating for timely medical attention. The mobile application could empower patients to take a more active role in monitoring their health, especially those in remote areas with limited access to specialists.

This study represents a pioneering step in digital health for Southeast Asia, combining a validated clinical tool with modern technology to address a pressing public health issue. If successful, the Thai PainPREDICT app could serve as a scalable model for other countries facing similar challenges. The long-term vision includes integrating the tool into national e-health systems and potentially using artificial intelligence to provide personalized management recommendations, ultimately transforming the care pathway for millions of people living with diabetes and neuropathic pain worldwide. The importance of such research cannot be overstated, as it bridges the gap between advanced medical knowledge and practical, accessible patient care, particularly in regions where healthcare resources are stretched. Investing in culturally adapted digital health solutions is essential for achieving health equity and ensuring that all patients, regardless of location, have the opportunity for early diagnosis and effective management of chronic conditions like diabetic neuropathy.