Effectiveness of VIRTUAL FIBROWALK STUDY
Effectiveness of Virtual Multicomponent Treatment for Fibromyalgia: VIRTUAL FIBROWALK STUDY
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2020
CompletedFirst Submitted
Initial submission to the registry
September 25, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2021
CompletedOctober 6, 2020
October 1, 2020
1.1 years
September 25, 2020
October 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Revised Fibromyalgia Impact Questionnaire (FIQR)
The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration.
Through study completion, an average of 3 months
Secondary Outcomes (3)
Tampa Scale for Kinesiophobia (TSK-11)
Through study completion, an average of 3 months
Hospital Anxiety and Depression Scale (HADS)
Through study completion, an average of 3 months
Physical Function of the 36-Item Short Form Survey (SF-36)
Through study completion, an average of 3 months
Study Arms (3)
TAU + multicomponent treatment VIRTUAL FIBROWALK
EXPERIMENTALVIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
Treatment as Usual (TAU)
ACTIVE COMPARATORTreatment-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
Physiotherapy part of VIRTUA FIBROWALK
ACTIVE COMPARATORThe physiotherapy part of the VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE) and therapeutic exercise.
Interventions
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) 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.
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
You may qualify if:
- Adults from 18 to 75 years-old.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vall d'Hebrón Hospital
Barcelona, Spain
Related Publications (1)
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.
PMID: 36116229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Marsal, PhD
Vall d'Hebrón Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2020
First Posted
October 1, 2020
Study Start
September 21, 2020
Primary Completion
November 10, 2021
Study Completion
November 10, 2021
Last Updated
October 6, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share