Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)
Recruiting · NCT07677631 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Bari
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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 is running
5 locations listed.
- Pain Unit, Policlinico di Bari, University of Bari Aldo Moro (coordinating center) - Bari, Italy
- Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-Malpighi - 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
- Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona - Verona, Italy