Facial-expression and biomarker approach to recognize pain in fibromyalgia.
Analysis of Facial Expressions for Pain Recognition: Using Artificial Intelligence and Biomarkers as a Pain Diagnostic Tool in Fibromyalgia, a Pilot Study
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 |
|---|---|
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Faculdade de Ciências Médicas de Minas Gerais Academic / other |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Trial ID | NCT06813352 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Belo Horizonte, Minas Gerais
- 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
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.