Refining mUltiple Artificial intelliGence strateGies for Automatic Pain Assessment Investigations: RUGGI Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorValentina Cerrone

About this trial

This single-center, non-profit, observational-interventional study aims to develop artificial intelligence (AI) models for the automatic assessment of chronic pain (APA - Automatic Pain Assessment). The study will enroll adult patients with chronic pain of various origins (oncologic and non-oncologic). Participants will undergo multidimensional evaluations that include clinical assessments, self-report questionnaires, bio-signal collection (e.g., EEG, EDA, HRV, GSR, PPG), and facial expression analysis via infrared thermography and video recordings.

The primary objective is to calibrate and test machine learning and deep learning models to recognize and predict the presence and severity of pain using multimodal data inputs. Secondary objectives include evaluating the effectiveness of pain treatments, assessing quality of life, and developing a standardized APA dataset for future research.

All data collection procedures are non-invasive and safe, and include tools like wearable sensors and standardized neurocognitive tests. The study is approved by the Italian Ethics Committee (Comitato Etico Territoriale Campania 2) and complies with GDPR and EU AI regulations.

Eligibility criteria

Qualifiers

Adults (≥18 years old) with chronic pain, defined according to IASP and ICD-11 as pain that persists or recurs for more than three months.

Chronic primary pain (e.g., fibromyalgia, irritable bowel syndrome, chronic headaches)

Chronic secondary non-cancer pain (e.g., low back pain, osteoarthritis, post-surgical pain)

Chronic cancer-related pain (due to cancer or its treatment)

Disqualifiers

Current treatment with psychotropic drugs or presence of active psychiatric disorders (e.g., psychosis, major depression).

Known history of alcohol or substance abuse.

Pregnancy or breastfeeding.

Age under 18 years.

Trial design

Treatments tested in this trial

  • Multimodal AI-Based Pain Assessment

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Valentina Cerrone

Lead sponsor

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Sponsor institution

University of Salerno, Italy

Collaborator

Federico II University

Collaborator