Clinical trial NCT04571528: Effectiveness of VIRTUAL FIBROWALK STUDY
Official title: Effectiveness of Virtual Multicomponent Treatment for Fibromyalgia: VIRTUAL FIBROWALK STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: multicomponent treatment
Fibromyalgia
chronic pain
pain neuroscience education
therapeutic exercise
cognitive behavioural therapy
mindfulness
randomized controlled trial
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Through study completion, an average of 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Through study completion, an average of 3 months
measure: Physical Function of the 36-Item Short Form Survey (SF-36)
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebrón Hospital
Study officials:
affiliation: Vall d'Hebrón Hospital
name: Sara Marsal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.