Thai PainPREDICT for detecting neuropathic pain in people with diabetes
Thai Version of PainPREDICT: Translation, Validation, and Mobile Application Development for Screening Painful Diabetic Neuropathy in Diabetes Patients
This project will test a Thai-language PainPREDICT questionnaire and a companion mobile app to help identify neuropathic pain in adults with type 1 or type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 277 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chulalongkorn University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pathum Wan, Bangkok) |
| Trial ID | NCT07195045 on ClinicalTrials.gov |
What this trial studies
The project will translate and culturally adapt the internationally used PainPREDICT questionnaire into Thai, followed by psychometric testing including internal consistency and test-retest reliability. A mobile application embedding the Thai PainPREDICT will be developed and refined through clinician and patient usability testing using the System Usability Scale and qualitative feedback. Finally, diagnostic accuracy and real-world usability will be evaluated in 200–300 adults with diabetes by comparing questionnaire results to clinician diagnosis and objective neurophysiological tests such as nerve conduction studies and quantitative sensory testing. The study is conducted at King Chulalongkorn Memorial Hospital and includes subgroup analyses to gauge performance in resource-limited settings.
Who should consider this trial
Good fit: Adults aged 18 or older with type 1 or type 2 diabetes who can communicate in Thai and provide informed consent are ideal candidates.
Not a fit: People with neuropathy from other known causes, significant cognitive impairment or severe psychiatric illness, or those who cannot use Thai-language tools are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the Thai PainPREDICT and app could enable earlier, more accessible detection and monitoring of painful diabetic neuropathy and reduce delays to treatment.
How similar studies have performed: The PainPREDICT questionnaire has been validated internationally, but its formal translation, cultural adaptation, and mobile integration for Thai patients are novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pathum Wan, Bangkok
- King Chulalongkorn Memorial hospital, The Thai Red Cross Society — Pathum Wan, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Jakkrit Amornvit, MD — King Chulalongkorn Memorial Hospital
- Study coordinator: Jakkrit Amornvit, MD
- Email: jakkrit.a@chula.ac.th
- Phone: +66622169338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.