Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-26 @ 9:58 AM
Study NCT ID:
NCT04284566
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2020-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBROWALK
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: