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NCT06138171Completed

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

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

Source: ClinicalTrials.gov · Last updated 4 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
1006 (actual)
First submitted
7 Nov 2023
Start date
1 Oct 2023
Primary completion date
30 Sept 2024
Lead sponsor
University of Roma La Sapienza
Diseases
Migraine
NCT number
NCT06138171

What you commit to

  • Study type: Observational
  • Participants enrolled: 1006
  • From 1 Oct 2023 to the primary completion date, 30 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • severe psychiatric disorders and/or cognitive impairment
  • history of other chronic pain disorder(s)
  • history of other neurological disorders besides migraine

Other

  • difficulties in comprehension/expression in Italian

Who the study is looking for

  • age range 18-65 years
  • education \> 5 years
  • diagnosis of FM according to Wolfe, 2016
  • diagnosis of CM according to Olesen, 2017
  • diagnosis of VU according to Bornstein et al., 2016

Age in the registry: 18 years to 65 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Sapienza University of Rome, Department of Dynamic and Clinical Psychology and Health Studies
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RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.