Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)

Sponsor
University of Bari
Study ID
NCT07677631
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain
  • Fibromyalgia
  • Nociplastic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 1, 2026
Start date
Sep 10, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
423 participants (estimated)

Arms

  • Arm: Fibromyalgia cases
    Adults with fibromyalgia diagnosed per the 2016 ACR criteria.
  • Arm: Non-fibromyalgia chronic pain controls
    Adults with chronic non-cancer pain of defined nociceptive or neuropathic origin who do not meet the 2016 ACR criteria for fibromyalgia.

Primary Outcome Measure

Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases [ Time Frame: Baseline (T0) ]

Central Contacts

Related Studies