Painful Diabetic Neuropathy (PDN)PainPREDICT-ThNCT07195045
Thai PainPREDICT Validation Study
A study testing Thai PainPREDICT Questionnaire and Mobile Application in people with Painful Diabetic Neuropathy (PDN) and Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation), run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy (PDN), Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation), Type 1 Diabetes Mellitus (T1DM)
- What is being tested?
- Thai PainPREDICT Questionnaire and Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteThailand
- Study dates
- 28 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial hospital, The Thai Red Cross Society
Pathum Wan, Bangkok, 10330
Jakkrit Amornvit, MD, +66622169338, jakkrit.a@chula.ac.th
About this study
Official title: 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.
Read the 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.
- 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
- Being tested
- Thai PainPREDICT Questionnaire and Mobile Application
- 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
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Neuralgia, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thai PainPREDICT Questionnaire and Mobile ApplicationDiagnostic test
Also called PainPREDICT (Thai Version), PainPREDICT App
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Thai PainPREDICT Questionnaire and Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 12 months (Phases 1 and 2)
Secondary outcomes (2)
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.
Measured: 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).
Measured: Months 16-26 (Phase 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start28 Aug 2025
- Primary completion27 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Neuropathy (PDN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 277 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakkrit Amornvit, MD., Chulalongkorn University
- Investigators
- Jakkrit Amornvit, MD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195045
- Sponsor's protocol ID
- COA No. 1084/2025
- Other IDs
- IRB No. 0296/68
- Acronym
- PainPREDICT-Th
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thai Version of PainPREDICT: Translation, Validation, and Mobile Application Development for Screening Painful Diabetic Neuropathy in Diabetes Patients
- ClinicalTrials.gov ID
- NCT07195045
- Acronym / sponsor ID
- PainPREDICT-Th / COA No. 1084/2025
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 277 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 27 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Painful Diabetic Neuropathy (PDN) Group | Experimental | Diagnostic Test: Thai PainPREDICT Questionnaire and Mobile ApplicationAdults 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. |
| Arm 2: Non-PDN Diabetic Control Group | Active comparator | Diagnostic Test: Thai PainPREDICT Questionnaire and Mobile ApplicationAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thai PainPREDICT Questionnaire and Mobile ApplicationAlso: PainPREDICT (Thai Version), PainPREDICT AppThe 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. | Diagnostic test | Arm 1: Painful Diabetic Neuropathy (PDN) Group, Arm 2: Non-PDN Diabetic Control Group |
Primary outcome
Reliability and Validity of Thai PainPREDICT Questionnaire
Time frame: Baseline through 12 months (Phases 1 and 2)
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.
2 secondary outcomes
Usability of the Thai PainPREDICT Mobile Application
Time frame: Months 7-15 (Phase 2)
Diagnostic Accuracy of Thai PainPREDICT Questionnaire in Clinical Setting
Time frame: Months 16-26 (Phase 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakkrit Amornvit, MD principal investigator
King Chulalongkorn Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thai PainPREDICT Questionnaire and Mobile Application in people with Painful Diabetic Neuropathy (PDN) and Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation), run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakkrit Amornvit, MD (+66622169338, jakkrit.a@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and Validity of Thai PainPREDICT Questionnaire (time frame: Baseline through 12 months (Phases 1 and 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.