Status:
UNKNOWN
Cost-utility and Immuno-inflammatory Effects of the FIBROWALK in Patients With Fibromyalgia (the On&Out Study)
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Universitat Autonoma de Barcelona
Ministerio de Ciencia e Innovación, Spain
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The present project will evaluate through a randomised controlled clinical trial with 6-month follow-up, the efficacy and cost-utility (6-month time horizon) of the multicomponent FIBROWALK programme ...
Detailed Description
Introduction: The On\&Out study is aimed at assessing the efficacy, cost-utility and immuno-inflammatory underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings:...
Eligibility Criteria
Inclusion
- Patients of both sexes, between 18 and 65 years of age.
- Diagnosis of fibromyalgia according to the ACR 2010/2011 criteria.
- Understanding Spanish.
Exclusion
- Psychological treatment (within the last year) or current.
- Comorbid presence of severe mental disorder (e.g. schizophrenia) or other terminal clinical conditions or scheduled treatments that may interrupt study follow-up.
- Inability to complete the weekly sessions/modules of the programme on a regular basis.
- Being in litigation with the health system with the aim of obtaining a permanent leave of absence.
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2023
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT05377567
Start Date
September 15 2022
End Date
November 20 2023
Last Update
July 28 2022
Active Locations (1)
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1
Hospital Vall Hebron
Barcelona, Spain, 08035