Facial-expression and biomarker approach to recognize pain in fibromyalgia.
Official title: Analysis of Facial Expressions for Pain Recognition: Using Artificial Intelligence and Biomarkers as a Pain Diagnostic Tool in Fibromyalgia, a Pilot Study
Run by Faculdade de Ciências Médicas de Minas Gerais · NCT06813352 · Data updated 2026-11-12
This tests whether an AI tool that reads facial expressions together with saliva biomarkers can measure pain levels in people with fibromyalgia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 122 (estimated) |
| Sponsor | Faculdade de Ciências Médicas de Minas Gerais Academic / other |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Status | Recruiting |
| Started | November 17, 2025 |
| Main results expected | February 1, 2026 |
| Study ends | September 1, 2026 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT06813352 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with fibromyalgia who can follow instructions, have no diagnosed cognitive deficit, and are willing to attend the outpatient clinic for facial recording and saliva sampling.
✕Probably not a fit
Patients taking medications that affect anxiety or depression, those with cognitive impairment, or people unable to comply with procedures are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study enrolled 122 participants, 61 with fibromyalgia and 61 without, to compare facial-expression patterns and molecular markers associated with pain. Researchers recorded facial expressions and analyzed them with a convolutional neural network to identify patterns linked to pain intensity. They also collected 1 mL saliva samples to extract DNA, RNA, and plasma proteins measured by ELISA and RT-qPCR, and correlated those findings with self-reported measures like the Visual Analogue Scale and Generalized Pain Index. Statistical agreement and bias were examined using Kappa and Bland-Altman analyses to validate the combined AI and biomarker approach.
Why it matters
Potential benefit: If successful, the approach could provide more objective and reliable measures of pain that improve diagnosis and treatment monitoring for people with fibromyalgia.
How similar studies have gone: AI-based facial-expression analysis has shown promise in other pain settings, but combining such algorithms with molecular biomarkers in fibromyalgia is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The inclusion criteria are patients with no diagnosed cognitive deficit and who are willing to take part in the study. Exclusion Criteria: * Exclusion criteria are patients who use medication that can affect anxiety or depression or inability to understand the instructions.
Where it's running
-
Outpatient Faculty Medical Sciences
Belo Horizonte, Minas Gerais, Brazil Recruiting
Study contacts
- Study coordinator: Alessandra H De Souza, PhD
- Email: alessandra.souza@cienciasmedicasmg.edu.br
- Phone: 55-31984205240
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.