Personality, Defences, Central Sensitization, and Trauma in Women With Chronic Migraine, Fibromyalgia, and Vulvodynia

NCT06138171 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1006

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Fibromyalgia
  • Chronic Migraine, Headache
  • Vulvodynia

Interventions

OTHER

Psychological self-reported measures assesment (questionnaire)

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).

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER
  • Pavia IRCCS Mondino di Pavia

    collaborator UNKNOWN
  • Azienda Policlinico Umberto I

    collaborator OTHER
  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Federica M Galli, AP · University of Roma La Sapienza

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-09-30
Completion
2024-12-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06138171 on ClinicalTrials.gov