Thai PainPREDICT Validation Study

Sponsor
Chulalongkorn University
Study ID
NCT07195045
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Thai PainPREDICT Questionnaire and Mobile Application — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Sep 26, 2025
Start date
Aug 28, 2025
Status verified
Sep 2025
Primary completion
Aug 27, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
277 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm 1: Painful Diabetic Neuropathy (PDN) Group
    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.
  • Active Comparator: Arm 2: Non-PDN Diabetic Control Group
    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.

Primary Outcome Measure

Reliability and Validity of Thai PainPREDICT Questionnaire [ Time Frame: Baseline through 12 months (Phases 1 and 2) ]

Central Contacts

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