Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)
CompletedNot applicableNCT04284566
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The main objective of this study is to analyse the effectiveness of the FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone.
Study details
- Official title
- Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness in Patients With Fibromialgia (FIBROWALK STUDY): A Randomized Controlled Trial
- Conditions
- Interventions
- Behavioral: TAU + multicomponent treatment FIBROWALK
- Behavioral: Treatment as Usual (TAU)
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Collaborators
- Parc Sanitari Sant Joan de Déu; Universitat Autonoma de Barcelona
- Start date
- 2018-11-01
- Primary completion
- 2020-07-08
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. fulfil the 2010/2011 American College of Rheumatology (ACR) FM diagnostic criteria. The diagnosis was verified by a rheumatologist (MA) of the CSSSU 2. adults \> 18 years old, and 3. provide written informed consent. Exclusion Criteria: 1. To have a terminal illnesses or programmed interventions that might interrupt the study. 2. No stringent eligibility criteria were established due to the naturalistic nature of the RCT. Excluding patients with lower education or comorbidities might have turned away many patients from our RCT who would otherwise be eligible, that is we put emphasis on external validity. All recruited patients were considered capable of following the multicomponent therapy if they were allocated to it. Lack of adherence to drugs or home activities was not an exclusion criterion given the nature of our trial and we analysed data from all participants who underwent random allocation. Treatment allocation was performed by the clinical trials unit in accordance with computer-generated randomisation sequences.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04284566