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

NCT06138171 | Completed DMC

• 1 other identifier: 0001979
• Study Type: observational
• Target: 1,006
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

central sensitivity; traumatic childhood experiences; mental pain; environmental sensitivity; defense mechanisms

Outcome Measures

Primary Outcomes (6)

• Central sensitivity index

  Central Sensitivity Inventory (CSI) (Chiarotto et al., 2018). Range scores go from 0 to 100, with higher scores indicating worse conditions.

  Day 0

• Traumatic experiences index

  Traumatic Experiences Checklist (TEC) (Nijenhuis et al., 2002). Range scores go from 0 to 29, with higher scores indicating more traumatic experiences in life.

  Day 0

• Personality traits

  PID-5 Short form (Thimm et al., 2016). Range scores go from 0 to 75, with higher scores indicating higher presence of disfunctional personality traits

  Day 0

• Defense mechanisms

  Defense Mechanism Rating Scales - DMRS-SR-30 (Di Giuseppe et al., 2020). Range scores go from 3.5 to 7, with higher scores indicating more consistent use of defense mechanisms.

  Day 0

• Mental pain

  Mental Pain Questionnaire (Svicher et al., 2019). Range scores go from 0 to 10, with higher scores indicating worse conditions.

  Day 0

• Environmental sensitivity

  Highly Sensitive Person Scale (HSP-12) (Aron \& Aron, 1997; Lionetti et al., 2018). Range scores go from 1 to 7, with higher scores indicating worse conditions.

  Day 0

Secondary Outcomes (7)

• Presence and intensity of psychological symptoms of depression, anxiety and psychosomaitcs

  Day 0

• Physical and Psychological Quality of life index

  Day 0

• Alexithymic traits

  Day 0

• Percieved Social Support

  Day 0

• Sexual Satisfaction

  Day 0

Study Arms (4)

Fibromyalgia - FM

Cohort of women diagnosed with FM recruited consecutively in the clinical department following the criteria: * age range 18-65 years * education \> 5 years * diagnosis of FM according to Wolfe, 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

Other: Psychological self-reported measures assesment (questionnaire)

Chronic migraine - CM

Cohort of women diagnosed with CM recruited consecutively in the clinical department following the criteria: * age range 18-65 years * education \> 5 years * diagnosis of CM according to Olesen, 2017 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

Other: Psychological self-reported measures assesment (questionnaire)

Vulvodynia - VU

Cohort of women diagnosed with VU recruited consecutively in the clinical department following the criteria: * age range 18-65 years * education \> 5 years * 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

Other: Psychological self-reported measures assesment (questionnaire)

Control group (no chronic pain condition)

Cohort of women recruited consecutively from the general population with the following criteria: * age range 18-65 years * education \> 5 years * no previous diagnosis of chronic pain conditions 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

Other: Psychological self-reported measures assesment (questionnaire)

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).

Chronic migraine - CM; Control group (no chronic pain condition); Fibromyalgia - FM; Vulvodynia - VU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study involves the collection of data from a self-administered questionnaire in several Italian centers specializing in the above-mentioned clinical conditions. The four centers involved in the recruitment of the participants will be the Università di Milano IRCCS Sant'Ambrogio Galeazzi under the haed of Prof. Sarzi-Puttini and Dott. Valeria Giorgi, the IRCCS Mondino di Pavia under the head of Prof. Cristina Tassorelli and Prof. Sara Bottiroli, The Policlino San Matteo of Paviaunder the head of Prof. Rossella Nappi and Dott. Lara Tiranini, and the Policlinico Umberto I of Sapienza University of Rome under the head of Dott. Cristina Iannuccelli. Questionaires will be accessible online through a web survey available on the Google.forms platform. Participants will provide an informed consent before accessing the survey, and the questionnaire will be anonymous with no remuneration provided.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Milan: collaborator
• Pavia IRCCS Mondino di Pavia: collaborator
• Azienda Policlinico Umberto I: collaborator

Study Sites (1)

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

Rome, 00100, Italy

Location

Related Publications (76)

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  PMID: 32915024 RESULT

MeSH Terms

Conditions

Fibromyalgia; Headache; Vulvodynia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Federica M Galli, AP

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore Associato (Associate Professor)

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 1, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

IT (1)