Emotional Allodynia in Fibromyalgia: AEQ Validation
Official title: Pain, Emotional Allodynia, and Relational Load (PEARL): A Multicenter Validation Study of the Emotional Allodynia Questionnaire in Fibromyalgia
Run by University of Bari · NCT07677631 · Data updated 2026-11-12
This study tests whether the Emotional Allodynia Questionnaire (AEQ) reliably identifies emotional overreaction to social cues in adults with fibromyalgia compared with other chronic pain patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 425 (estimated) |
| Sponsor | University of Bari Academic / other |
| Locations | 5 sites (Bari and 4 other locations) |
| Status | Recruiting |
| Started | September 10, 2025 |
| Main results expected | June 2027 |
| Study ends | August 2027 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT07677631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with a clinical fibromyalgia diagnosis (2016 ACR criteria) and chronic non-cancer pain, fluent in Italian, with consent.
✕Probably not a fit
Patients without fibromyalgia or those not experiencing emotional allodynia may not benefit from AEQ-based insights.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study evaluates the AEQ’s psychometric properties in a fibromyalgia population and a control group with nociceptive or neuropathic chronic pain. It aims to replicate the AEQ’s internal structure, establish discriminative accuracy versus non-fibromyalgia pain, and assess test-retest reliability over ~40 days. Participants complete the AEQ along with several related scales, with data collected via paper questionnaires and later entered online. The design is cross-sectional at baseline with a follow-up for reliability, and no intervention is administered. Primary setting includes Italian tertiary pain centers coordinated by the University of Bari.
Why it matters
Potential benefit: If successful, the AEQ could become a practical tool to identify emotional allodynia in fibromyalgia, helping tailor patient care.
How similar studies have gone: Preliminary validation existed in a single-center fibromyalgia sample; this study seeks replication and broader validation with healthier discrimination against other pain types.
Who can join: the full rules
Show full inclusion / exclusion criteria
CASES (fibromyalgia) Inclusion Criteria: * Age 18 years or older * Clinical diagnosis of fibromyalgia confirmed according to the 2016 revision of the ACR criteria * Chronic non-cancer pain for at least 3 months * Ability to understand and independently complete self-report questionnaires in Italian * Willingness to provide written informed consent Exclusion Criteria: * Active oncological disease or cancer-related pain * Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder (assessed by clinical history) * Severe cognitive impairment precluding questionnaire completion * Inability to understand or complete questionnaires in Italian CONTROLS (non-fibromyalgia chronic pain) Inclusion Criteria: * Age 18 years or older * Chronic non-cancer pain for at least 3 months with a defined nociceptive or neuropathic generator (e.g., radiologically or surgically documented degenerative, structural, or post-surgical musculoskeletal pain, or neuropathic pain with an identifiable neurological lesion or disease) * Not meeting the 2016 ACR criteria for fibromyalgia * Ability to understand and independently complete self-report questionnaires in Italian * Willingness to provide written informed consent Exclusion Criteria (parallel to cases): * Diagnosis of fibromyalgia or another recognized nociplastic primary pain condition (e.g., primary chronic widespread pain) * Active oncological disease or cancer-related pain * Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder * Severe cognitive impairment precluding questionnaire completion * Inability to understand or complete questionnaires in Italian Note: ongoing pharmacological treatment for pain or mental health is not an exclusion criterion in either group; Major Depressive Disorder and Panic Disorder are recorded at baseline and used in covariate-adjusted and stratified analyses.
Where it's running
-
Pain Unit, Policlinico di Bari, University of Bari Aldo Moro (coordinating center)
Bari, Italy Recruiting -
Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-Malpighi
Bologna, Italy Not yet recruiting -
Department of Medical Sciences and Public Health, University of Cagliari
Cagliari, Italy Not yet recruiting -
Department of Women, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli
Naples, Italy Not yet recruiting -
Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona
Verona, Italy Not yet recruiting
Study contacts
- Principal investigator: Alberto Corriero, MD, PhD — University of Bari Aldo Moro, Pain and ICU Section
- Study coordinator: Alberto Corriero, MD, PhD
- Email: alberto.corriero@gmail.com
- Phone: +39 3280072443
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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.