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Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)

RecruitingNCT07677631
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Pain, Emotional Allodynia, and Relational Load (PEARL): A Multicenter Validation Study of the Emotional Allodynia Questionnaire in Fibromyalgia
Sponsor
University of Bari
Collaborators
Universita di Verona; University of Campania Luigi Vanvitelli; University of Cagliari; IRCCS Azienda Ospedaliero-Universitaria di Bologna
Start date
2025-09-10
Primary completion
2027-06
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Italy
Total sites listed
5

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07677631