Prevalence of Pain Disorders in Employees of French Furniture Shop.

Chronic Pain Clinical Trial

— PREVADouleur  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277885
• Other study ID #: CHU-347
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 1, 2019
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Somatoform Disorders

Intervention

Other:
• chronic pain
work related chronic pain

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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