Fibromyalgia Syndrome in France: The Role of Assessment and Management of Sleep Disorders

Fibromyalgia Clinical Trial

— FIBOBS  

Official title:

Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04775368
• Other study ID #: RIPH2_ANDRE_FIBOBS
• Secondary ID: 2020-A02940-39
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 7, 2023

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Emile Roux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, divided into three categories (poor quality of sleep in general, sleep apnea syndrome, restless legs syndrome), using self-questionnaires in patients with Fibromyalgia Syndrome (FMS) consulting within a CPS. The interaction between these sleep disorders and other symptoms of FMS will also be analyzed using self-administered questionnaires. Based on the hypothesis that sleep disorders associated with FMS are only imperfectly assessed and/or treated in CPS, the FIBOBS study will also interview pain physician in order to know both the diagnostic tools used and the recommended management when sleep disorders are suspected in the context of FMS. In addition, this study will provide a better understanding of the symptoms of FMS, their impact and how patients feel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Administering diagnosis orientation questionnaires for the screening of possible sleep disorders
Several diagnosis orientation self-questionnaires will be conducted by the patient following his or her inclusion in order to detect, among other things, possible sleep disorders.

Locations

Country	Name	City	State
France	CHU Amiens Picardie - CETD	Amiens
France	CH Ardèche Méridionale	Aubenas
France	CH Henri Mondor	Aurillac
France	CHU Jean Minjoz - CETD	Besançon
France	CH Béziers	Béziers
France	HIA Clermont Tonnerre	Brest
France	CHU Hôpital Côte de Nacre - CETD	Caen
France	CH Métropole Savoie	Chambéry
France	CH de Chartres	Chartres
France	CHU Gabriel Montpied	Clermont-Ferrand
France	CH du Pays de Craponne	Craponne-sur-Arzon
France	CH de Dax	Dax
France	Centre Hospitalier de Dieppe	Dieppe
France	CH de Dreux	Dreux
France	CHI Fréjus - Saint Raphaël	Fréjus
France	GMH	Grenoble
France	CHD Vendée	La Roche-sur-Yon
France	GH Littoral Atlantique	La Rochelle
France	CHU Grenoble Alpes	La Tronche
France	CH Pierre Gallice	Langeac
France	CH de Versailles	Le Chesnay
France	Centre Hospitalier du Mans	Le Mans
France	CH Emile Roux	Le Puy-en-Velay
France	CHU Dupuytren 2 - Centre de la douleur chronique	Limoges
France	Clinique Mutualiste de la Porte de Lorient	Lorient
France	Centre de la douleur Lille métropole	Marquette-lez-Lille
France	CHU Timone	Marseille
France	Hôpital Sainte Blandine	Metz
France	CHI de Mont-de-Marsan	Mont-de-Marsan
France	CH du Forez	Montbrison
France	GHR MSA - CETD - Site Muller	Mulhouse
France	CHU Nord	Nantes
France	CHR Orléans	Orléans
France	GH Paris Saint Joseph	Paris
France	CH de Perpignan	Perpignan
France	CHU de Poitiers	Poitiers
France	CH René Dubos	Pontoise
France	CH Annecy Genevois	Pringy
France	CHU de Saint-Etienne	Saint-Étienne
France	CH Saint-Nazaire	Saint-Nazaire
France	Hôpital Pierre Paul Riquet - CHU Toulouse	Toulouse
France	CH de Valence	Valence
France	CH Jacques Lacarin	Vichy
France	Hôpital Nord Ouest - Site Villefranche-sur-Saône	Villefranche-sur-Saône
France	Médipôle Hôpital Mutualiste	Villeurbanne
France	CH Jacques Barrot	Yssingeaux

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Emile Roux	University Hospital, Clermont-Ferrand, Walisco

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the prevalence of sleep disorders in general in patients with FMS	The prevalence of sleep disorders will be estimated from the results of the Pittsburgh Sleep Quality Index Questionnaire (PSQI) which is a generic, validated 19-item self-administered questionnaire for measuring sleep problems.	Only once, by the patient within 14 days of inclusion.
Primary	Assessing the prevalence of sleep disorders for the specific risk of sleep apnea syndrome in patients with FMS	The prevalence of sleep disorders for the specific risk of sleep apnea syndrome will be estimated from the results of the STOP-BANG questionnaire. This questionnaire guide the diagnosis of sleep apnea syndrome and is composed of 8 items.	Only once, by the patient within 14 days of inclusion.
Primary	Assessing the prevalence of sleep disorders for the specific risk of restless legs syndrome in patients with FMS	The prevalence of sleep disorders will be estimated from the results of the simple question which is a rapid screening tool that provides a diagnosis of probable restless legs syndrome (RLS). Patients who answer positively to this question will complete the International Restless Legs Syndrome (IRLS) questionnaire which assesses the severity of restless legs syndrome on four levels: mild, moderate, severe and very severe.	Only once, by the patient within 14 days of inclusion.
Secondary	Assessing the pain severity of FMS	The pain severity of the FMS will be assessed using the WPI (widespread pain index) questionnaire, which represents the generalized pain index.	Only once, by the patient within 14 days of inclusion.
Secondary	Assessing the symptom severity of FMS	The symptom severity of the FMS will be assessed using the SSS (symptom severity scale) questionnaire, which corresponds to the symptom severity scale.	Only once, by the patient within 14 days of inclusion.
Secondary	Assessing the impact of the FMS on the patient's daily life	The impact of the FMS on the patient's daily life will be assessed by the QIF (French version of the Fibromyalgia Impact Questionnaire (FIQ)). This validated and commonly used questionnaire makes it possible to evaluate the functional incapacity and the repercussions of the FMS on daily life by evaluating the major symptoms: pain, fatigue, sleep disorders but also morning stiffness, anxiety and depression.	Only once, by the patient within 14 days of inclusion.
Secondary	Assessing the feeling of pain and the impact of pain on the patient's daily behavior	The painful feeling and the impact of pain on the patient's daily behavior will be assessed by the Concise Pain Questionnaire (QCD), the French version of the Brief Pain Inventory (BPI). This validated questionnaire makes it possible to assess the impact of pain on seven general aspects of the patient's life.	Only once, by the patient within 14 days of inclusion.
Secondary	Assess the patient's state of anxiety and depression	The patient's state of anxiety and depression will be assessed using the validated HADS - Hospital Anxiety and Depression Scale questionnaire.	Only once, by the patient within 14 days of inclusion.
Secondary	Describe the assessment tools used by the pain physician to evaluate the main symptoms of FMS (pain, asthenia, sleep and cognitive disorders)	The assessment tools used by the pain physician to evaluate patients' pain, asthenia, sleep disorders and memory problems will be recorded in the "physician questionnaire".	Only once, by the pain physician at the inclusion.
Secondary	Describe the therapeutic measures (drug and non-drug) in place for the management of FMS	Therapeutics proposed for the management of symptoms associated with FMS will be identified (names of drug and non-drug treatments, care practices).	Once by the physician at the inclusion, and once by the patient within 14 days of inclusion.
Secondary	Assess the percentage of patients for whom sleep disorders have been previously diagnosed and treated.	The "patient questionnaire" will identify patients already diagnosed and treated for a sleep disorder. This will allow comparison with the prevalence calculated from the three screening questionnaires.	Throught study completion, an average of 4 months.