Status:
COMPLETED
Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Parc Sanitari Sant Joan de Déu
Universitat Autonoma de Barcelona
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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.
Detailed Description
This is a two-arm RCT focused on the potential efficacy of the multicomponent program FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone. FIBROWALK combines multicomponent approach base...
Eligibility Criteria
Inclusion
- fulfil the 2010/2011 American College of Rheumatology (ACR) FM diagnostic criteria. The diagnosis was verified by a rheumatologist (MA) of the CSSSU
- adults \> 18 years old, and
- provide written informed consent.
Exclusion
- To have a terminal illnesses or programmed interventions that might interrupt the study.
- 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.
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT04284566
Start Date
November 1 2018
End Date
July 8 2020
Last Update
September 5 2021
Active Locations (1)
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1
Vall d'Hebrón Hospital
Barcelona, Spain, 08035