RecruitingOBSERVATIONAL

The Biopsychosocial Model to Identify Risk Factors for Chronic Post-traumatic Pain in ICU Patients

This research project investigates why some people experience ongoing pain long after a serious injury, known as chronic post-traumatic pain. It aims to understand how different factors – like the injury itself, how it's treated, a patient's mood, and their social situation – all work together. Researchers will collect information from medical records, take small blood samples, and ask patients to complete questionnaires during their hospital stay and at 3 and 6 months later. By looking at these things, the study hopes to find early warning signs, so doctors can better predict which patients might be at risk of developing this type of long-term pain before they leave the hospital.

At a glance

Status

Recruiting

Sponsor

University Hospital, Montpellier

Enrolment target

400

Start

29 Jul 2024

Estimated completion

29 Jul 2027

Post Traumatic Chronic Pain

What is this study about?

This study is looking into why some people develop lasting pain, called chronic post-traumatic pain, after an injury, particularly those who have had accidents affecting their bones like fractures. This kind of ongoing pain can make it hard to do daily activities, affect your mood, and impact your overall quality of life. The pain is considered chronic if it lasts for more than three months after the injury.

The main aim of this research is to find out what puts people at risk of developing this long-term pain. Researchers will carefully collect lots of information throughout a patient's hospital stay. This includes details about the injury itself – like how it happened, how severe it was, and where on the body it occurred – as well as information about the treatments they receive. They will also ask about psychological factors (like stress or anxiety) and social factors (like support from family and friends), and how the patient is coping with their injury and recovery.

In addition to gathering information from medical records and questionnaires, the study will also collect small blood samples from patients from when they are admitted until they leave the hospital. Researchers are particularly interested in a substance found in the blood called BDNF, which may play a role in how the body's pain system can become oversensitive, leading to long-term pain. By combining all this information – clinical details, psychological and social factors, and biological markers – the study hopes to build a complete picture. The ultimate goal is to create a way to predict which patients are most likely to develop chronic post-traumatic pain, helping doctors to identify and potentially help these individuals sooner.

Key takeaways

This study investigates why some people get long-term pain after an injury.
It combines medical records, blood tests, and questionnaires.
The goal is to find early risk factors for chronic post-traumatic pain.
Information is collected during hospital stay and at 3 and 6 months after discharge.
Identifying at-risk patients early could lead to better support in the future.

Who may be eligible?

To be able to take part in this study, you would need to be an adult (18 years or older) and have had a serious injury involving at least one broken bone. This study isn't for people with very minor injuries or for those whose only injury was a broken bone in their wrist, a head injury, minor face injury, or an injury only to their digestive system.

The study welcomes both men and women. If you're unsure whether you meet these descriptions, it's always best to discuss it with your doctor or the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did your injury include at least one broken bone?
Is your injury more serious than just a minor facial injury or an isolated wrist fracture?
Are you not suffering only from a head injury or only an injury to your digestive system?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what it would involve:

Throughout your hospital stay, the research team would collect information from your medical records about your injury and the treatment you receive. You would also be asked to complete some questionnaires to assess your psychological and social well-being, and how you're feeling about your recovery. Small blood samples would be taken from you, usually when you're already having blood tests for your usual medical care, from the time you're admitted to the hospital until you are discharged. After you leave the hospital, you would have follow-up assessments at 3 months and 6 months, which would involve completing more questionnaires. The total duration of your active participation, including follow-up, would be about 6 months.

Potential risks and benefits

Taking part in this study could help future patients by improving our understanding of long-term pain after injury and potentially leading to better ways to identify those at risk. There are no direct personal medical benefits for you, as the study aims to understand the condition, not to treat it. The risks are very low; blood samples are small and taken when you're already having blood tests. Completing questionnaires might take some time and could involve thinking about sensitive topics. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (1)

Department of Anesthesiology and critical care, Lapeyronie University Hospital
Verified postcode
Montpellier, France· Recruiting

Common questions

What is chronic post-traumatic pain?

It's pain that continues for more than three months after an injury, and it can significantly impact a person's daily life and well-being.

Why are you taking blood samples?

Researchers are looking for specific markers in the blood that might be linked to how the body's pain system changes after an injury, potentially contributing to long-term pain.

Will I get any special treatment as part of the study?

No, this study is about understanding risk factors, not about providing new treatments. You will receive the standard medical care for your injury.

What happens to my information?

All the information collected, including your medical details and survey answers, will be kept confidential and used only for research purposes, with your identity protected.

How long will I be involved?

Your involvement, including follow-up questionnaires after leaving the hospital, would last for about 6 months.

How to find out more

Sophie Bringuier, PhD

s-bringuierbranchereau@chu-montpellier.fr +33467338661 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.