Prevalence of Pain Disorders in Employees of French Furniture Shop. (PREVADouleur)

February 1, 2019 updated by: University Hospital, Clermont-Ferrand

Evaluation of the Prevalence of Pain Disorders in a Professional Context Among Employees of French Furniture Shop.

In France, the Direction of Research, Studies, Evaluation and Statistics, in their 2015 report on "Chronic pain: the state of health of the population in France - Indicators associated with the Public health ", shows that 34.6% of the working population declare themselves to be facing psycho-social risks, including chronic pain disorders.

The main survey conducted in France on chronic pain showed that 32% of French people expressed daily pain for more than 3 months, with 20% reporting chronic pain of moderate or severe intensity. According to a report by the HAS in 2009, about 30% of patients consulting for pain in pain center (CETD) are working and 20% are on sick leave or work-related accidents.

Chronic pain would also be responsible in France for the limitation of professional activities in 6% of 25-64 year olds, 15% job losses, 12% changes in work responsibilities, 12% changes in employment and 18 % of associated depressions. In addition, 40% of chronic pain patients experienced a direct impact at work: loss, change in responsibilities and activity.

Combined with the difficulty of understanding and thus treating chronic pain, these data demonstrate the challenge faced by occupational health services in their preventive, curative and palliative approach to chronic pathologies. Innovation for any new prevention and therapy for chronic pain then becomes necessary.

The main objective of this first study will be the evaluation of the prevalence of pain disorders among the employees of French furniture shop. .

Study Overview

Status

Status

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

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

In order to have the earliest possible representativeness of French furniture shop, a "virtual" store will be created from 400 volunteer employees from 14 French furniture shop. Each job will be represented and the number of employees per job will respect the average proportion observed in the French furniture shop.

Following the on-site presentation of the details of the survey, by a doctor from Clermont-Ferrand University Hospital, volunteers will be informed within their company of the start of the survey. Each volunteer employee will have access to the information document (paper format) explaining in detail the purpose, content and conduct of the survey. If the voluntary collaborator agrees to participate, he / she will be asked to respond to the survey via the computer platform of the Clermont-Ferrand University Hospital.

Before completing the questionnaires, the employee will be asked to participate in the survey, via a YES / NO choice on the computer platform, which will serve as proof of non-opposition. The employee will be free to reverse his initial decision at any time by informing the coordinating center.

Volunteers who have agreed to participate in the study will be asked to respond to the survey questionnaires during each survey. Volunteers will have no obligation to participate in all investigations.

The data manager of the coordinating center will build a specific and secure platform via the REDCap website (http://project-redcap.org/). Volunteer collaborators will be provided with the web link to respond to the survey directly on the REDCap platform at their workplace or at home.

The deployment of the survey to employees will be carried out over a period of 1 month.

This survey will take place in 4 separate campaigns with a 4-month interval: October / February / June / October (to give an overview of the season effect on the data, as well as a longitudinal aspect). During each campaign, employees will be notified and can participate in the survey. Each employee may participate in one or more investigations.

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 (Actual)

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.
400

Contacts and Locations

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

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

employees of French furniture shop

Description

Inclusion Criteria:

  • All voluntary employees of French furniture shop
  • Non-opposition to participation in the study

Exclusion Criteria:

  • Employees 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

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
Prevalence of painful disorders
Time Frame: At the end of each survey campaign (a campaign lasts 1 month and is repeated every 4 months for 12 months, a total of 4 campaigns).
An employee will be considered painful if the pain intensity is greater than 3/10 on a numerical rating scale (0 = no pain at 10 = worst possible pain).
At the end of each survey campaign (a campaign lasts 1 month and is repeated every 4 months for 12 months, a total of 4 campaigns).

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
Sociodemographic characterization
Time Frame: at day 1
Questionnaires
at day 1
Number of medical and paramedical visits over the past 12 months for a cause of pain.
Time Frame: during each survey campaign (4 campaigns over a 12-month period).
Questionnaires
during each survey campaign (4 campaigns over a 12-month period).
Anxiety and Depression Score
Time Frame: at day 1
Questionnaire HADS
at day 1
Quality of life
Time Frame: at day 1
Questionnaire SF-12
at day 1
Catastrophism
Time Frame: at day 1
Questionnaire PCS
at day 1
Characterization of pain
Time Frame: at day 1
Questionnaire BPI
at day 1
Characterization of kinesiophobia
Time Frame: at day 1
Questionnaire TSK
at day 1
Screening for neuropathic pain
Time Frame: at day 1
Questionnaire DN4 interview
at day 1
Characterization of lumbar pain.
Time Frame: at day 1
Questionnaire FABQ
at day 1

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

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.
November 1, 2017

Primary Completion (Actual)

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.
November 5, 2018

Study Completion (Actual)

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.
February 1, 2019

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).
September 4, 2017

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.
September 7, 2017

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.
September 11, 2017

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.
February 4, 2019

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.
February 1, 2019

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.
February 1, 2019

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.
  • CHU-347

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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