Effectiveness of Virtual Multicomponent Treatment for Fibromyalgia: VIRTUAL FIBROWALK STUDY
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Revised Fibromyalgia Impact Questionnaire (FIQR)
- Last Updated
- 5 years ago
Overview
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
Investigators
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.
Outcomes
Primary Outcomes
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time Frame: 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 Outcomes
- Physical Function of the 36-Item Short Form Survey (SF-36)(Through study completion, an average of 3 months)
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 3 months)
- Tampa Scale for Kinesiophobia (TSK-11)(Through study completion, an average of 3 months)