RecruitingNot ApplicableNCT07195045

Thai PainPREDICT Validation Study

Thai Version of PainPREDICT: Translation, Validation, and Mobile Application Development for Screening Painful Diabetic Neuropathy in Diabetes Patients

Sponsor

Chulalongkorn University

Enrollment

277 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus (T1DM)Type 2 Diabetes Mellitus (T2DM)Neuropathic Pain Diabetes Complications Painful Diabetic Neuropathy (PDN)Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is validating a Thai-language version of a tool called PainPREDICT, which helps identify whether nerve pain (neuropathy) in people with diabetes is related to small nerve fiber damage — with the goal of improving pain assessment in Thai diabetes patients. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with Type 1 or Type 2 diabetes mellitus - You are able to communicate in Thai - You are willing to provide written informed consent **You may NOT be eligible if...** - Your nerve damage is caused by something other than diabetes (such as alcohol, chemotherapy, HIV, or other systemic diseases) - You have significant cognitive impairment or neurological conditions that prevent you from completing a questionnaire - You have severe psychiatric illness that would interfere with study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTThai 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.

Locations(1)

King Chulalongkorn Memorial hospital, The Thai Red Cross Society

Pathum Wan, Bangkok, Thailand

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NCT07195045

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