Traumatic Events in Childhood, Attachment, Pain Perception, Epigenetic Marks, Quality of Life and Resilience.

NCT06077097 | Completed DMC

• 1 other identifier: 2022-A02519-34
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Adverse Childhood Experiences; Attachment Styles; Chronic Stress; Resilience, Psychological; Quality of Life; Epigenesis, Genetic

Outcome Measures

Primary Outcomes (1)

• Observe the reported pain intensity and pain affect in individuals experiencing chronic pain

  Pain intensity and pain affect will be measured using the Numerical Rating Scale (NRS). The Numerical Rating Scale is typically an 11-point scale, with 0 representing "no pain" and 10 representing "the worst pain imaginable." In the case of pain intensity, higher scores on the NRS indicate worse pain, with 10 being the most severe pain. For pain affect, higher scores on the NRS may indicate more negative affective responses related to pain.

  Baseline. Through study completion, an average of 1 year.

Secondary Outcomes (6)

• Attachment Styles

  Baseline. Through study completion, an average of 1 year.

• Adverse childhood experiences

  Baseline. Through study completion, an average of 1 year.

• Assess the Quality of Life of individuals experiencing chronic pain

  Baseline. Through study completion, an average of 1 year.

• Pain cognitions

  Baseline. Through study completion, an average of 1 year.

• Pain Interference

  Baseline. Through study completion, an average of 1 year.

Other Outcomes (2)

• Epigenetic measurements related to childhood adversity

  Baseline. Through study completion, an average of 1 year.

• Stress Measurement

  Baseline. Through study completion, an average of 1 year

Interventions

Biological samples GENETIC

This project also includes an auxiliary exploratory biological study of subcellular mechanisms, using high-throughput sequencing (Next Generation Sequencing, NGS) to identify gene expression variations in order to determine the resilience/vulnerability of the variables studied with respect to the DC experience (cytogenetics and transcriptome).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lorraine: lead

Study Sites (1)

Ur 4360 Apemac

Metz, Lorraine,, 57000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

1\) measurement of cortisol levels 2) measurement of methylation of OXTR, NR3C1 and FKBP5 receptors and genes For the measurement of cortisol and methylation of the OXTR, NR3C1 and FKBP5 receptors and genes, blood cells will be collected, within the chronic pain structures, during the participant's inclusion visit if he/she agrees to participate in the biological ancillary study. The blood sample will be taken from the participant's fingertip by transcutaneous pricking, collecting a few drops of blood capillary. According to the recent study by Walker et al (98), DNA methylation profiles from dried blood spots are of good quality, strongly correlated with those of paired EDTA tube samples (mean r = 0.991).

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• CYRIL CYRIL, Pr

  UR 4360 APEMAC, UNIVERSITY OF LORRAINE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Methodologist/Epidemiologist Head of Research Unit, Pierre Jane Centre

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: October 11, 2023
• Study Start: April 12, 2023
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)