Chronic PainNCT06077097
Traumatic Events in Childhood, Attachment, Pain Perception, Epigenetic Marks, Quality of Life and Resilience.
An observational study of Chronic Pain and Adverse Childhood Experiences, run by University of Lorraine at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Adverse Childhood Experiences, Attachment Styles
- What is being tested?
- Biological samples
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2023to 18 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pain, Adverse Childhood Experiences, Attachment Styles, Chronic Stress, Resilience, Psychological, Quality of Life
- Being tested
- Biological samples
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesGenetic
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline. Through study completion, an average of 1 year.
Secondary outcomes (6)
Attachment Styles
The different Attachment Styles (AS) will be identified using the Experiences in Close Relationships-Revised Questionnaire (ECR-R). It is a 36-item self-report questionnaire that assesses AS in romantic relationships. It consists of two dimensions: attachment anxiety and attachment avoidance. Participants rate each of the 36 statements using a 7-point likert scale which ranges from 1-strongly disagree to 7-strongly agree. Interpretation: Higher scores indicate a worse outcome in terms of attachment-related anxiety/avoidance, reflecting greater insecurity in romantic relationships.
Measured: Baseline. Through study completion, an average of 1 year.
Adverse childhood experiences
The number of Adverse Childhood Experiences (ACEs) will be assessed using the Adverse Childhood Experiences International Questionnaire (ACE-IQ).
The total number of ACEs to which the participant has been "exposed" is summed to create an ACE score ranging from 0 (no ACEs) to 13. A score of 0 ACEs means a low level of adversity and a score of 13 means a major level of adversity.
Measured: Baseline. Through study completion, an average of 1 year.
Assess the Quality of Life of individuals experiencing chronic pain
Quality of life will be assessed using the SF-12 questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. Higher scores on the SF-12 scale generally signify better physical and mental health, fewer limitations in daily activities, less pain, and a more positive perception of overall well-being. Conversely, lower scores suggest poorer health, more limitations, more pain, and a less positive perception of well-being.
Measured: Baseline. Through study completion, an average of 1 year.
Pain cognitions
Pain cognitions, assessed using the Pain Beliefs and Perceptions Inventory (PBPI) The Pain Beliefs and Perceptions Inventory (PBPI) is a questionnaire comprising 16 items that assess individuals' beliefs about pain across four primary dimensions: mystery, permanence, constancy, and self-blame. Respondents rate each item on a 4-point scale, ranging from -2 (strongly disagree) to 2 (strongly agree). In summary, higher scores on these PBPI subscales reflect stronger beliefs and perceptions in the respective dimensions of pain. Interpretation of these scores should consider the context of the study and the specific research questions or hypotheses being investigated.
Measured: Baseline. Through study completion, an average of 1 year.
Pain Interference
The impact of pain on daily behaviour, measured using the Concise Pain Questionnaire (CPQ). The questionnaire assesses the degree of pain interference in seven daily activities using a Likert scale from 0 (no interference) to 10 (complete interference). Higher scores indicate more significant pain-related disruption to these activities, while lower scores suggest minimal interference. A minimum of four completed items out of seven is required to calculate the mean pain interference score, offering a concise measure of pain's impact on daily life.
Measured: Baseline. Through study completion, an average of 1 year.
Pain resilience
Pain resilience processes as measured by the Pain Resilience Scale modified version for chronic pain (PRS)
This scale comprises 12 items and 2 factors measuring cognitive/affective positivity and behavioral perseverance respectively. Respondents rate their agreement with each item using a Likert scale ranging from 0 ("not at all") to 4 ("all the time").
Higher scores in the cognitive/affective factor indicate a greater perceived ability to maintain cognitive and emotional positivity despite severe or prolonged pain.
Higher scores in the behavioral perseverance factor indicate a greater perceived ability to persist in various behaviors even when faced with prolonged or severe pain.
Measured: Baseline. Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start12 Apr 2023
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Rotonda, University of Lorraine
- Investigators
- CYRIL CYRIL, Pr, Principal investigator, UR 4360 APEMAC, UNIVERSITY OF LORRAINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077097
- Sponsor's protocol ID
- 2022-A02519-34
- Status last verified
- Jul 2025
- First submitted
- 25 Aug 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06077097
- Acronym / sponsor ID
- 2022-A02519-34
- Conditions
- Chronic Pain, Adverse Childhood Experiences, Attachment Styles, Chronic Stress, Resilience, Psychological, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samplesThis 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). | Genetic | – |
Primary outcome
Observe the reported pain intensity and pain affect in individuals experiencing chronic pain
Time frame: Baseline. Through study completion, an average of 1 year.
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.
6 secondary outcomes
Attachment Styles
Time frame: Baseline. Through study completion, an average of 1 year.
Adverse childhood experiences
Time frame: Baseline. Through study completion, an average of 1 year.
Assess the Quality of Life of individuals experiencing chronic pain
Time frame: Baseline. Through study completion, an average of 1 year.
Pain cognitions
Time frame: Baseline. Through study completion, an average of 1 year.
Pain Interference
Time frame: Baseline. Through study completion, an average of 1 year.
Pain resilience
Time frame: Baseline. Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CYRIL CYRIL, Pr principal investigator
UR 4360 APEMAC, UNIVERSITY OF LORRAINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Adverse Childhood Experiences, run by University of Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe the reported pain intensity and pain affect in individuals experiencing chronic pain (time frame: Baseline. Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.