Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bari

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

423 Participants
are grouped into 2 trial groups

Locations

5
Pain Unit, Policlinico di Bari, University of Bari Aldo Moro (coordinating center)70124, Bari Italy
Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-Malpighi40138, Bologna Italy
Department of Medical Sciences and Public Health, University of Cagliari Cagliari Italy
Department of Women, Child and General and Specialized Surgery, University of Campania Luigi Vanvitelli Naples Italy

Sponsors 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