The main objective of this study is to analyse the effectiveness of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL FIBROWALK treatment in the short- and longterm.
This is a tree-arm RCT focused on the safety and potential effectiveness of the
multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU
alone and on the comparation of the physiotherapy part of the multicomponent program.
- VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education
(PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness
training.
- Physiotherapy part of VIRTUAL FIBROWALK combines multicomponent approach based on Pain
Neuroscience Education (PNE) and therapeutic exercise.
- The main hypothesis is that improvement on functional impairment of patients with
fibromyalgia can be achieved by the direct intervention on mechanisms such as
kinesiophobia and fear avoidance
Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): - Pain neuroscience education (15 min.) - Cognitive restructuring (15 min.) - Mindfulness techniques (15 min.) - Physical exercise(15 min.) - Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.
Behavioral: Treatment as Usual (TAU)
Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.
Behavioral: TAU + Physiotherapy part of VIRTUAL FIBROWALK
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients: - Pain neuroscience education (30 min.) - Physical exercise(30 min.) - Treatment as Usual (TAU). Standard pharmacological treatment usually provided to patients with fibromyalgia.
Inclusion Criteria:
- Adults from 18 to 75 years-old.
- 1990 American College of Rheumatology (ACR) classification criteria + the 2011
modified ACR diagnostic criteria for fibromyalgia
- Able to understand Spanish and accept to participate in the study.
Exclusion Criteria:
- Participating in concurrent or past RCTs (previous year).
- Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative
diseases (i.e. Alzheimer) that that would limit the ability of the patient to
participate in the RCT.
Vall d'Hebrón Hospital
Barcelona, Spain
Investigator: Mayte Serrat, MSc
Contact: +34934893891
mserrat@vhebron.net
Mayte Serrat, MSc
+34934893891 - 6644
mserrat@vhebron.net
Elena Granell
+34934893891
elena.granell@vhir.org
Sara Marsal, PhD, Principal Investigator
Vall d'Hebrón Hospital