Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2020-09-21
2021-11-10
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAU + multicomponent treatment VIRTUAL FIBROWALK
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
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.
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.patient
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.
Physiotherapy part of VIRTUA FIBROWALK
The physiotherapy part of the VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE) and therapeutic exercise.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Sara Marsal, PhD
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebrón Hospital
Locations
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Vall d'Hebrón Hospital
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Serrat M, Albajes K, Navarrete J, Almirall M, Lluch Girbes E, Neblett R, Luciano JV, Moix J, Feliu-Soler A. Effectiveness of two video-based multicomponent treatments for fibromyalgia: The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial. Behav Res Ther. 2022 Nov;158:104188. doi: 10.1016/j.brat.2022.104188. Epub 2022 Sep 8.
Other Identifiers
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PR(AG)249/2020
Identifier Type: -
Identifier Source: org_study_id
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