Clinical trial NCT06077097: Traumatic Events in Childhood, Attachment, Pain Perception, Epigenetic Marks, Quality of Life and Resilience.
Official title: Traumatic Events in Childhood, Attachment, Pain Perception, Epigenetic Marks, Quality of Life and Resilience: When Psychological Dimensions Interfere With the Hospital Management of Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Adverse Childhood Experiences
Attachment Styles
Chronic Stress
Resilience, Psychological
Quality of Life
Epigenesis, Genetic
Lead sponsor: University of Lorraine
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of participants who have been diagnosed with a chronic pain syndrome for more than 6 months and who will be admitted for the first time to a hospital pain management programme in one of the regional structures specialised in the management of chronic pain (SDC), i.e. the Centre of Evaluation and Treatment of pain at the "Belle-Isle" hospital (private hospitals in Metz, France UNEOS Group) and the Pain Consultation of the Regional University Hospital (CHRU) at Nancy, France. Participants will be included for 12 months. All patients meeting the inclusion criteria and not meeting the non-inclusion criteria will be invited by the physicians performing the first consultation at the centres of inclusion to participate in the study before the start of any medical programme.

Brief summary: In the present research study, aiming to explore the links between several psychological factors and chronic pain, the research seeks to develop an inclusive framework to investigate the role of adverse childhood experiences (ACEs) in patients' pain perception and overall quality of life throughout their pain management programs. Specifically, attachment styles (AS) and pain-related resilience processes are considered as potential mediators of the effectiveness of chronic pain management programs. Additionally, biological measures are proposed to investigate physiological parameters of pain and to further explore the degree of consistency between self-reported measures, ACEs, ASs, chronic stress, and several epigenetic biomarkers.

Detailed description: One in four French adults suffers from chronic pain (CP), making it one of the main causes of long-term disability and disease burden in France. Despite the various pain management plans, which have brought their share of improvements, CP remains extremely resistant to treatment, and its annual health costs represent a major national problem. Considering that 70% of CP patients remain severely undertreated, managed exclusively by general practitioners and CP specialists, there is an emerging need to implement more effective and cost-efficient interdisciplinary pain management programs, following a biopsychosocial framework for the management of pain. This framework integrates biological, psychological, and social measures and their interactions to highlight an individual's unique pain state.

The psychological concept of "adverse childhood experiences" (ACEs) may play a role in the development and maintenance of CP. Researchers point to a frequency-dependent relationship between ACEs and chronic conditions in adulthood, with a higher number of ACEs leading to more severe CP problems in adulthood. However, research is still in its infancy, and it cannot be concluded that there is a causal relationship between ACEs and the development of persistent pain.

It is, therefore, essential to consider several factors that may potentially mediate this relationship, such as the psychological concept of adult attachment style. The latter refers to the way relationships with others are formed, shaped in early childhood. Attachment patterns can be characterized along two dimensions: attachment anxiety (worry about the availability of others) and attachment avoidance (discomfort with proximity and interdependence). Insecure attachment patterns (high anxiety and/or avoidance) have been associated with the development of chronic conditions such as fatigue, medically unexplained CP, and migraines. Furthermore, in patients with CP, attachment anxiety is associated with increased pain. Experimental pain studies have also shown a positive relationship between attachment anxiety and pain. In contrast, the results concerning attachment avoidance are contradictory. Attachment patterns are of great importance for the current project, as CP management programs are usually based on patient-to-patient talk groups, and the medical devices are occupied by doctors and carers. Therefore, the medical discourse, as well as the discourse of peers (i.e. other patients), will not have the same impact or importance depending on whether patients have developed secure attachments or not.

Based on the evidence presented above, it seems that the psychological constructs of ACEs and attachment may open up new avenues for understanding individual differences in the context of CP management programs. The research is particularly interested in complementing this line of reasoning by investigating individual differences in various epigenetic markers and levels of resilience of individuals to better understand how potentially traumatic life events will have different effects on patients and their treatment effectiveness.

The project aims to develop a more inclusive framework to study the role of ACEs in patients' pain perception and overall quality of life throughout their pain treatment, exploring the potential mediating effect of attachment styles, resilience, and deoxyribonucleic acid (DNA) methylation levels. The project is innovative in its assessment of multiple genetic receptors through the application of an ancillary biological study and in its application of a longitudinal research design.

Eligibility criteria: Inclusion Criteria:

* Have a chronic pain syndrome persisting for at least six months
* Have been referred to a chronic pain management programme at the Centre of evaluation and treatment of chronic pain at the "Belle- Isle" hospital (private hospital in Metz, France) or at the Pain Consultation of the Regional University Hospital of Nancy, France
* Be between 18 and 65 years old
* Be able to read and write in French (be able to understand the information and fill in the questionnaires independently)
* Agree to participate in the project and sign the consent form

Exclusion Criteria:

* Have received pain management in a specialised chronic pain facility (of any kind) during their lifetime
* Have physical, cognitive and/or linguistic deficiencies that make it impossible to fill in the questionnaires
* Have a psychiatric history (psychosis type)
* Have a drug or alcohol dependency
* Be a protected adult, under guardianship or curatorship
* Being pregnant or breastfeeding

Primary outcomes:
measure: Observe the reported pain intensity and pain affect in individuals experiencing chronic pain
timeFrame: Baseline. Through study completion, an average of 1 year.
Secondary outcomes:
measure: Attachment Styles
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Adverse childhood experiences
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Assess the Quality of Life of individuals experiencing chronic pain
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Pain cognitions
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Pain Interference
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Pain resilience
timeFrame: Baseline. Through study completion, an average of 1 year.
Other outcomes:
measure: Epigenetic measurements related to childhood adversity
timeFrame: Baseline. Through study completion, an average of 1 year.
measure: Stress Measurement
timeFrame: Baseline. Through study completion, an average of 1 year
Locations:
city: Metz
country: France
facility: Ur 4360 Apemac
state: Lorraine,
Study officials:
affiliation: UR 4360 APEMAC, UNIVERSITY OF LORRAINE
name: CYRIL CYRIL, Pr
role: PRINCIPAL_INVESTIGATOR
References: