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This research was funded by the Fundacio Doctor Ferran in 2017 (granted to RCA) and Instituto de Salud Carlos III, Ministry of Economy and Competitiveness (Spain), awarded on the 2018 call under the Health Strategy Action 2017-2020, within the National Research Program oriented to Societal Challenges, within the Technical, Scientific and Innovation Research National Plan 2017-2020 with reference PI18/00943 (granted to AB and CAM), co-funded with European Union ERDF funds (European Regional Development Fund). This research was also funded by a predoctoral fellowship from the Fundacio Institut Universitari per a la recerca a l'Atencio Primaria de Salut Jordi Gol i Gurina in 2020 (granted to RCA).

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Effectiveness of a Multicomponent Program for Fibromyalgia Patients in a Primary Care Setting (FIBROCARE Program): A Pragmatic Randomized Controlled Trial

Publicat a:Journal Of Clinical Medicine. 14 (1): 161- - 2025-01-01 14(1), DOI: 10.3390/jcm14010161

Autors: Angelats, Rosa Caballol; Goncalves, Alessandra Queiroga; Abellana, Rosa; Carrasco-Querol, Noelia; Corts, Anna Pamies; Serra, Gemma Gonzalez; Benaiges, Dolors Gracia; Anguera, Immaculada Fuste; Baticon, Blanca Cuevas; Reverte, Maria Fibla; Valles, Noemi Espuny; Cavalle, Montserrat Marti; Suazo, Nuria Pinana; Bargallo, Joan Estivill; Guerrero, Maria Angels Lopez; Guerrero, Carolina Lopez; Acin, Pilar Perez; Callarisa, Immaculada Matamoros; Baucells, Jordi; Ciurana, Adria Suazo; Fernandez-Saez, Jose; Llorca, M Rosa Dalmau; Berenguera, Anna; Martin, Carina Aguilar

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Background/Objectives: Multicomponent, non-pharmacological therapies are the preferred first-line treatments for fibromyalgia (FM), but little is known about them in primary care settings. Our study assessed the effectiveness of the FIBROCARE Program in improving the quality of life, functional impact, mood, and pain of people with FM. Methods: We conducted a pragmatic, randomized controlled trial that was not blinded for both patients and the professionals delivering the treatments in the study groups. We compared a group receiving non-pharmacological multicomponent group therapy (MT) based on health education, physical exercise, and cognitive-behavioral therapy with another group receiving the usual clinical care. The MT group was treated in the primary care context in Catalonia (Spain) through 12 consecutive weekly sessions. Both groups were followed up with at the end of the MT group sessions and 6 and 12 months after the group sessions with the Short-Form 36 (SF-36) v2 Health Survey questionnaire, the Hospital Anxiety and Depression Scale (HADS-A and HADS-D), the Visual Analog Scale, and the Revised Fibromyalgia Impact Questionnaire (ClinicalTrials.gov: NCT04049006). Results: Improvements in pain intensity, functional impact, physical health, fatigue, and emotional problems that affect daily activities in the MT group lasted up to 12 months. Benefits measured by the SF-36 Mental Health dimension and the HADS-A subscale were lost after 6 months. Effects on the SF-36 Social Functioning dimension and HADS-D present at 6 months persisted for up to 12 months. Generally, the longer the time since the FM diagnosis, the better was a patient's mood. Conclusions: The FIBROCARE Program effectively improves all the studied health outcomes except patient mood, since anxiety symptoms persist. The program should reinforce patient psychological support overall, focusing particularly on the years initially after diagnosis.

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