Personality, Defences, Central Sensitization, and Trauma in Women With Chronic Migraine, Fibromyalgia, and Vulvodynia
CompletedNCT06138171
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 resear…
Study details
- Official title
- 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
- Conditions
- Fibromyalgia
- Chronic Migraine, Headache
- Vulvodynia
- Interventions
- Other: Psychological self-reported measures assesment (questionnaire)
- Sponsor
- University of Roma La Sapienza
- Collaborators
- University of Milan; Pavia IRCCS Mondino di Pavia; Azienda Policlinico Umberto I
- Start date
- 2023-10-01
- Primary completion
- 2024-09-30
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria: * 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 Exclusion criteria * severe psychiatric disorders and/or cognitive impairment * difficulties in comprehension/expression in Italian * history of other chronic pain disorder(s) * history of other neurological disorders besides migraine
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06138171