Clinical trial

Traumatic Events in Childhood, Attachment, Pain Perception, Epigenetic Marks, Quality of Life and Resilience: When Psychological Dimensions Interfere With the Hospital Management of Pain

Name

2022-A02519-34

Description

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.

Trial arms

Trial start

2023-04-12

Estimated PCD

2024-04-01

Trial end

2025-12-01

Status

Recruiting

Treatment

Biological samples

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).

Size

Primary endpoint

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

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

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'CROSS_SECTIONAL'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "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.\n\nThe 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)."}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-10-11

1 organization

1 product

9 indications

Organization

University of Lorraine

Product

Biological samples

Indication

Chronic Pain

Indication