Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)
Italy423 participantsStarted 2025-09-10
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Internal consistency of the Emotional Allodynia Questionnaire (AEQ) in fibromyalgia cases
Timeframe: Baseline (T0)
2
Factorial structure of the Emotional Allodynia Questionnaire (AEQ)
Timeframe: Baseline (T0)
3
Known-groups discriminative accuracy of the AEQ (AUC)