Cohort of Chronic Pain Patients (e-DOL cohort)

March 31, 2026 updated by: University Hospital, Clermont-Ferrand

Constitution and Analysis of a Cohort of Patients Followed in Pain Clinics and at Home in Real Life

Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.

In order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-DOL, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. The purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This first French e-cohort of chronic pain patients will allow real-life follow-up in order to generate big data including various information on chronic pain, associated-comorbidities, pain impacts on sleep, activity and psycho-emotional parameters, sociodemographic characteristics and pain treatments.

These data will be collected with he eDOL tool (smartphone application for patients and web platform for caregivers in pain clinics), integrating numerous repeatable questionnaires, weekly barometers, a therapeutic education module and a conversational agent (chat bot).

All of these data will also be linked with French health insurance care data in order to get an overview of comorbidities and patient care consumption in a medico-economic approach.

The study will include 20 pain clinics and a minimum of 5000 patients followed for 24 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens
        • Principal Investigator:
          • Eric SERRA
      • Bayeux, France, 14400
        • Not yet recruiting
        • CH Bayeux
        • Principal Investigator:
          • Lauriane FOUREL
      • Bordeaux, France, 33000
        • Not yet recruiting
        • CHU Bordeaux
        • Principal Investigator:
          • Virginie CORAND
      • Bron, France, 69500
        • Recruiting
        • Hospices civils Lyon
        • Principal Investigator:
          • Christian GOV
      • Grenoble, France, 38700
        • Recruiting
        • CHU Grenoble
        • Principal Investigator:
          • Marie FROST
      • Limoges, France, 87000
        • Recruiting
        • CHU Limoges
        • Principal Investigator:
          • Pascale VERGNE-SALLE
      • Lons-le-Saunier, France, 39000
        • Recruiting
        • Ch Lons Le Saunier
        • Principal Investigator:
          • Laurent BALP
      • Montpellier, France
        • Not yet recruiting
        • CHU Montepllier
        • Principal Investigator:
          • Patrick GINIES
      • Nantes, France, 44093
        • Recruiting
        • CHU Nantes
        • Principal Investigator:
          • Julien NIZARD
      • Nîmes, France, 30029
        • Recruiting
        • CHU Nimes
        • Principal Investigator:
          • François JESRYKA
      • Rennes, France, 35000
        • Recruiting
        • CHU Rennes
        • Principal Investigator:
          • akexandre MENET
      • Rouen, France, 76000
        • Recruiting
        • Chu Rouen
        • Principal Investigator:
          • Rodrigue DELEENS
      • Saint-Etienne, France, 42270
        • Recruiting
        • CHU Saint Etienne
        • Principal Investigator:
          • Christelle CREACH
      • Strasbourg, France
        • Recruiting
        • Hôpital Civil de Strasbourg
        • Principal Investigator:
          • Eric SALVAT
      • Toulouse, France, 31300
        • Recruiting
        • CHU Toulouse
        • Principal Investigator:
          • Nathalie CANTAGREL
      • Voiron, France, 38500
        • Recruiting
        • CH Voiron
        • Principal Investigator:
          • Gérard MICK
    • AURA
      • Clermont-Ferrand, AURA, France, 63000
        • Recruiting
        • CHU de Clermont-Ferrand - Service de Neurologie
        • Principal Investigator:
          • Xavier MOISSET
      • Clermont-Ferrand, AURA, France, 63000
        • Recruiting
        • Clermont-Ferrand University Hospital
        • Principal Investigator:
          • Noémie DELAGE
        • Principal Investigator:
          • Nicolas AUTHIER
        • Contact:
    • IDF
      • Boulogne-Billancourt, IDF, France, 92100
        • Recruiting
        • APHP Ambroise Paré
        • Principal Investigator:
          • Nadine ATTAL
      • Paris, IDF, France, 75012
        • Recruiting
        • APHP Saint Antoine
        • Principal Investigator:
          • Françoise LAROCHE
      • Paris, IDF, France, 75014
        • Recruiting
        • APHP Cochin
        • Principal Investigator:
          • Serge PERROT
    • IDf
      • Paris, IDf, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint Joseph
        • Principal Investigator:
          • Marguerite D'USSEL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patiant with chronic pain

Description

Inclusion Criteria:

  • All patients with chronic pain
  • patients equipped and regular users of a smartphone
  • Non-opposition to participation in the study

Exclusion Criteria:

  • Patient unable to understand or answer questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
chronic pain patients
All adult patients followed-up in participating pain clinics
Other: eDOL
e-health tool (mobile app for patients and web platform for caregivers in pain clinics)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
multidimensional characterisation of chronic pain patients
Time Frame: 5 years
Multimodal exploratory analysis of the determinants and repercussions of chronic pain, and their evolution in a real-life context, taking into account all environmental events likely to influence chronic pain (treatments, history, co-morbidities, etc.).
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Multivariate descriptive analyses
Time Frame: 5 years
Study the relationships between the measured criteria
5 years
Longitudinal analyses
Time Frame: 5 years
Describe the distribution and temporal evolution of the measured variables
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut ANALGESIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNI 2020 AUTHIER

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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