Effectiveness of VIRTUAL FIBROWALK STUDY

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK; Behavioral: Treatment as Usual (TAU); Behavioral: TAU + Physiotherapy part of VIRTUAL FIBROWALK

• Registration Number: NCT04571528
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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

Study Timeline

• Study Start: 2020-09-21
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-25
• Status Verified: 2020-10
• Study First Posted: 2020-10-01
• Last Update Submitted: 2020-10-04
• Last Update Posted: 2020-10-06
• Primary Completion: 2021-11-10
• Study Completion: 2021-11-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU + multicomponent treatment VIRTUAL FIBROWALK	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
Treatment as Usual (TAU)	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
Physiotherapy part of VIRTUA FIBROWALK	TAU + Physiotherapy part of VIRTUAL FIBROWALK	The physiotherapy part of the VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE) and therapeutic exercise.

Primary Outcome Measures

Name	Time	Method
Revised Fibromyalgia Impact Questionnaire (FIQR)	Through study completion, an average of 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Physical Function of the 36-Item Short Form Survey (SF-36)	Through study completion, an average of 3 months	Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function.
Hospital Anxiety and Depression Scale (HADS)	Through study completion, an average of 3 months	HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms.
Tampa Scale for Kinesiophobia (TSK-11)	Through study completion, an average of 3 months	TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.

Trial Locations

Locations (1)

Vall d'Hebrón Hospital; 🇪🇸 Barcelona, Spain