Thai PainPREDICT Validation Study (PainPREDICT-Th)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Complications; Neuropathic Pain; Type 2 Diabetes Mellitus (T2DM); Type 1 Diabetes Mellitus (T1DM); Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation); Painful Diabetic Neuropathy (PDN)
• Intervention / Treatment: Diagnostic test: Thai PainPREDICT Questionnaire and Mobile Application

Detailed Description

This study aims to translate, culturally adapt, and validate the PainPREDICT questionnaire for the Thai population, and to integrate it into a mobile application for use in both clinical and community settings. The study is structured into three phases. Phase 1 involves forward-backward translation of PainPREDICT into Thai, with expert panel review, pilot testing, and psychometric validation. Reliability will be assessed using internal consistency (Cronbach's alpha) and test-retest intraclass correlation coefficients, while validity will be examined through correlations with existing neuropathic pain measures (e.g., DN4) and neurophysiological studies (nerve conduction study, quantitative sensory testing). Phase 2 focuses on the design, development, and usability testing of a mobile application embedding the Thai PainPREDICT questionnaire. Clinicians and patients will test the application, and usability will be assessed with the System Usability Scale and qualitative interviews. Phase 3 evaluates diagnostic accuracy and real-world usability in 200-300 patients with type 1 or type 2 diabetes, including subgroup analysis in resource-limited settings. Diagnostic performance (sensitivity, specificity, positive and negative predictive values, ROC AUC) will be compared with physician diagnosis and objective neurophysiological tests.

Eligible participants are adults (≥18 years) with type 1 or type 2 diabetes who are able to communicate in Thai and provide informed consent. Patients with neuropathy from non-diabetic causes or significant cognitive impairment will be excluded. Recruitment will take place at Chula Neuroscience Center, King Chulalongkorn Memorial Hospital, and affiliated diabetes clinics. The study anticipates enrolling approximately 277 participants, which provides adequate power for psychometric validation and diagnostic accuracy testing. Both PDN patients and diabetic controls without PDN will be included to enable comparative analysis.

The primary outcome is the reliability and validity of the Thai PainPREDICT questionnaire for PDN screening. Secondary outcomes include usability of the mobile application, diagnostic accuracy compared with clinical and neurophysiological standards, and effectiveness in increasing PDN detection in resource-limited settings. The study also seeks to generate evidence on patient and provider satisfaction with the mobile platform. Data will be collected securely, stored in REDCap, and managed in compliance with Thai data protection regulations (PDPA 2019). Ethical approval will be obtained from the Institutional Review Board, Faculty of Medicine, Chulalongkorn University, and written informed consent will be required from all participants.

The expected benefit of this project is the development of a reliable and culturally valid Thai version of PainPREDICT, coupled with an accessible mobile application. This tool is anticipated to facilitate earlier detection of PDN, improve patient management pathways, and reduce disparities in access to care across Thailand. The study will also provide a model for adapting digital health screening tools for other populations with high diabetes burden. Ultimately, the project aims to strengthen evidence-based screening and management of neuropathic pain, improve patient quality of life, and contribute to the broader application of mHealth in chronic disease management.

• Study Type: Interventional
• Enrollment (Estimated): 277
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakkrit Amornvit, MD; Phone Number: +66622169338; Email: jakkrit.a@chula.ac.th
• Study Contact Backup: Name: Tharadon Deepracha, MSc; Phone Number: +66622169338; Email: tharadon.d@chulahospital.org

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Recruiting
      • King Chulalongkorn Memorial hospital, The Thai Red Cross Society
      • Contact: Jakkrit Amornvit, MD; Phone Number: +66622169338; Email: jakkrit.a@chula.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: Thai 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.; Other Names: PainPREDICT (Thai Version); PainPREDICT App
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.	Diagnostic test: Thai 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.; Other Names: PainPREDICT (Thai Version); PainPREDICT App

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Months 7-15 (Phase 2)
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).	Months 16-26 (Phase 3)

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Jakkrit Amornvit, MD, King Chulalongkorn Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2025
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: September 19, 2025
• First Posted (Estimated): September 26, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes Complications; Diabetic Neuropathy; Painful Diabetic Neuropathy; Digital Health Application; Mobile Health (mHealth); Neuropathic Pain Questionnaire; Screening Tool; Questionnaire Validation; Cross-Cultural Adaptation; PainPREDICT; Thai Population; Neuropathy Screening
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus, Type 2; Neuralgia; Diabetic Neuropathies; Diabetes Mellitus, Type 1; Diabetes Complications
• Other Study ID Numbers: COA No. 1084/2025; IRB No. 0296/68 (Other Identifier: Institutional Review Board, Faculty of Medicine, Chulalongkorn University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: IPD will be available beginning 12 months after publication of the main results and for up to 5 years thereafter.
• IPD Sharing Access Criteria: Researchers with a methodologically sound proposal may request access by contacting the principal investigator at Chulalongkorn University. Requests will be reviewed by the study steering committee. Data will be shared through a secure platform with a signed data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No