About this trial
The Emotional Allodynia Questionnaire (AEQ) is an 11-item self-report instrument that measures disproportionate emotional reactivity to low-intensity interpersonal cues(perceived unresponsiveness, exclusion, loss of reciprocity), a pattern termed emotional allodynia. It was preliminarily validated in a single-center fibromyalgia sample. PEARL (validation phase) is a multicenter, prospective, observational psychometric validation study that (1) replicates the internal structure and convergent validity of the AEQ in an independent fibromyalgia sample, (2) tests its known-groups (discriminative) accuracy in separating fibromyalgia from non-fibromyalgia chronic pain of defined nociceptive or neuropathic origin, expressed as the area under the ROC curve (AUC), and (3) assesses test-retest reliability. There is no intervention.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
5Sponsors and collaborators
University of Bari
Lead sponsor
University of Bari Aldo Moro
Sponsor institution
Universita di Verona
Collaborator
University of Campania Luigi Vanvitelli
Collaborator
University of Cagliari
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator