CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,006 enrolled
Drug / intervention
Psychological self-reported measures assesment (questionnaire)other
Likely dose
Not stated in record
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Search/NCT06138171
NCT06138171N/ACompleted

Psychological Layers of Nociplastic Pain: Cluster Analysis of The Role of Personality Traits, Defence Mechanisms, Central Sensitization, and Childhood Traumatic Experiences in Patients With Chronic Migraine, Fibromyalgia, and Vulvodynia

University of Roma La Sapienza·observational·Posted Nov 18, 2023·Updated Dec 4, 2024

In Brief

An observational study evaluating Psychological self-reported measures assesment (questionnaire) for Fibromyalgia and 2 related conditions. Completed, enrolled 1,006 participants across 1 site.

Detailed Summary

Chronic pain (CP) is a substantial healthcare challenge with considerable economic costs. Recently, the term Nociplastic Pain (NP) has been introduced as a third descriptor of mechanisms related to CP. NP describes conditions that arise from altered nociception despite no clear evidence of actual or threatened tissue damage. It represents a new way of describing somatoform painful conditions, originating from altered central-nervous pathways (e.g., central sensitization) and with the important involvement of clinical psychological factors. Among nociplastic chronic syndromes have been included fibromyalgia (FM), chronic migraine (CM) and vulvodynia (VU). These chronic pain disorders have been usually studied separately, although the high comorbidity rates. Many studies evidenced the role of psychosocial variables in the onset and maintenance of the burden related to these conditions. Among them, personality traits, defense mechanisms, central sensitization, and childhood traumatic experiences may play a pivotal role in the onset of the NP. The first aim of this study is to highlight possible psychosocial clusters of variables that are specific for each condition (FM, CM, and VU). A second aim, to improve the tailored psychological treatment devoted to these conditions, is to explore the association between FM, CM, and VU with depression, anxiety, somatization, quality of life, alexithymia, social support, sexual satisfaction, and functioning. This will make it possible to identify specifically for each condition the areas of greatest interest that can be investigated and treated in clinical intervention. To identify specific descriptors, NP conditions will be compared with a control group of subjects reporting other types of CP (e.g., knee arthrosis, rheumatoid arthritis). The study involves the collection of data from a self-administered questionnaire in several Italian centers specializing in the above-mentioned clinical conditions under the guidance of the research team of the Department of Dynamic and Clinical Psychology and Health Studies, PI Professor Federica Galli.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
202420252026
First PostedNov 18, 2023
Enrollment StartOct 1, 2023
Primary CompletionSep 30, 2024
Study CompletionDec 1, 2024
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 2.6 years ago

Interventions

Psychological self-reported measures assesment (questionnaire)other

The study involves the administration of a protocol of self-report questionnaires consisting of two parts: the main (about 25 minutes for the administration) and the optional one (additional 20 minutes). This decision stems from the realization of the length of the protocol, to increase the collection of data in pursuit of the main objective of the study (cluster analysis).