Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 300
Summary
- Conditions
- Fibromyalgia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel Assignment Single-blind, parallel-group, randomized controlled trialMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent program FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone. FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Thera...
This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent program FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone. FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training. The main objective of this RCT was two-fold: (a) To analyse the effectiveness of a 12-week multicomponent treatment as an add-on to Treatment (FIBROWALK) as Usual (TAU) to improve functional impact (primary outcome), as well as pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) compared to TAU; and (b) to explore the baseline differences between responders and non-responders in terms sociodemographic and clinical characteristics.
Tracking Information
- NCT #
- NCT04284566
- Collaborators
- Parc Sanitari Sant Joan de Déu
- Universitat Autonoma de Barcelona
- Investigators
- Study Chair: Sara Marsal, PhD Vall d'Hebrón Hospital
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