Status:
COMPLETED
Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders
Lead Sponsor:
Centre Hospitalier Emile Roux
Collaborating Sponsors:
Walisco
University Hospital, Clermont-Ferrand
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The FIBOBS study is a multi-centered, observational, prospective study carried out within specialized chronic pain structures (CPS) in France. It will estimate the prevalence of sleep disorders, divid...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Read, write and understand the French language
- Patient with a diagnosis of Fibromyalgia Syndrome according to ACR 2010 criteria: Painful symptoms present at the same intensity for at least 3 months, WPI ≥ 7 and SSS ≥ 5 OR 3 ≤ WPI ≤ 6 and SSS ≥ 9, Any other cause responsible for chronic osteoarticular pain must be excluded.Primary or secondary fibromyalgia is eligible, at the discretion of the investigator.
- Patient seen in consultation for the first time or for a follow-up visit if the patient has already been followed up in the specialized chronic pain structure for less than a year.
- Have access to an internet connection (for the realization of the "patient questionnaire")
- Patient affiliated to a social security system
- Written and signed informed consent
Exclusion
- Patient undergoing anti-cancer treatment or having completed treatment less than 2 years ago
- Patient under guardianship, deprived of liberty, safeguard of justice
- Pregnant or breastfeeding women
- Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
- Refusal to participate in research
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT04775368
Start Date
April 1 2021
End Date
March 7 2023
Last Update
May 1 2023
Active Locations (46)
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1
CHU Amiens Picardie - CETD
Amiens, France, 80054
2
CH Ardèche Méridionale
Aubenas, France, 07200
3
CH Henri Mondor
Aurillac, France, 15000
4
CHU Jean Minjoz - CETD
Besançon, France, 25030