Thai PainPREDICT Validation Study

NCT07195045 | Recruiting DMC

• 2 other identifiers: COA No. 1084/2025IRB No. 0296/68
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

PainPREDICT; Painful Diabetic Neuropathy; Diabetic Neuropathy; Neuropathic Pain Questionnaire; Mobile Health (mHealth); Questionnaire Validation; Screening Tool; Thai Population; Cross-Cultural Adaptation; Digital Health Application; Diabetes Complications; Neuropathy Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Usability of the Thai PainPREDICT Mobile Application

  Months 7-15 (Phase 2)

• Diagnostic Accuracy of Thai PainPREDICT Questionnaire in Clinical Setting

  Months 16-26 (Phase 3)

Study Arms (2)

Arm 1: Painful Diabetic Neuropathy (PDN) Group

EXPERIMENTAL

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

Arm 2: Non-PDN Diabetic Control Group

ACTIVE COMPARATOR

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

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.

Also known as: PainPREDICT (Thai Version), PainPREDICT App

Arm 1: Painful Diabetic Neuropathy (PDN) Group; Arm 2: Non-PDN Diabetic Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial hospital, The Thai Red Cross Society

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Neuralgia; Diabetes Complications

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jakkrit Amornvit, MD

  King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakkrit Amornvit, MD

CONTACT

+66622169338; jakkrit.a@chula.ac.th

Tharadon Deepracha, MSc

CONTACT

+66622169338; tharadon.d@chulahospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. Both patients and investigators are aware of PDN status, and the study does not use blinding. Outcomes are assessed by comparing questionnaire/app results with independent clinical and neurophysiological tests.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priciple Investigator

Model Details: Participants with type 1 or type 2 diabetes will be divided into two groups: those with painful diabetic neuropathy and those without neuropathy, matched by age, sex, and diabetes type. Both groups will complete the Thai PainPREDICT questionnaire (mobile application and/or paper version). Scores will be compared with clinical diagnosis and neurophysiological testing to assess reliability, validity, and diagnostic accuracy. The model uses parallel assessment rather than crossover or randomized allocation.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available beginning 12 months after publication of the main results and for up to 5 years thereafter.
• 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.

Locations

TH (1)