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Taking people in ItalyNo phase

Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)

Key facts

Where
Bari, Bologna, Cagliari, Naples, and Verona, ItalySee the 5 sites

Where in Italy

  • Pain Unit, Policlinico di Bari, University of Bari Aldo Moro (coordinating center)Bari, ItalyContact: Filomena Puntillo, MD (principal investigator)Taking people
  • Anesthesia and Pain Therapy Unit, IRCCS AOSP di Bologna, Policlinico S. Orsola-MalpighiBologna, ItalyContact: Samolsky Dekel Boaz, MD (principal investigator)Not yet recruiting
  • Department of Medical Sciences and Public Health, University of CagliariCagliari, ItalyContact: Gabriele Finco, MD (principal investigator)Not yet recruiting
  • Department of Women, Child and General and Specialized Surgery, University of Campania Luigi VanvitelliNaples, ItalyContact: Maria Caterina Pace, MD (principal investigator)Not yet recruiting
  • Department of Surgery, Dentistry, Pediatrics and Gynecology, University of VeronaVerona, ItalyContact: Vittorio Schweiger, MD, PhD (principal investigator)Not yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
University of Bari
Trial code
NCT07677631
Record updated
11 September 2026
Original description
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.Read full original descriptionShow less

Pain, Emotional Allodynia, and Relational Load (PEARL): A Multicenter Validation Study of the Emotional Allodynia Questionnaire in Fibromyalgia

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.

Inclusion: 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; 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: 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; 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; Inability to understand or complete questionnaires in Italian; CONTROLS (non-fibromyalgia chronic pain).

CASES (fibromyalgia).

ClinicalTrials.gov NCT07677631