Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-09
Brief Title:
Effectiveness of Experiential Fibrowalk Therapy
Sponsor:
Hospital Universitari Vall dHebron Research Institute
Organization:
Hospital Universitari Vall dHebron Research Institute
Study Overview
Official Title:
Effectiveness of Experiential Fibrowalk Therapy for Fibromyalgia Based on Pain Science Education Exercise Therapy Psychological Support and Nature Exposure A Pragmatic Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
EFW
Brief Summary:
The present project will evaluate through a randomised controlled clinical trial with 4-month follow-up the efficacy in clinical symptoms and quality of life 3-month time horizon of the multicomponent EXPERIENTIAL FIBROWALK programme in treating individuals diagnosed with fibromyalgia in compare with original Fibrowalk and virtual Fibrowalk Pre-post changes will be evaluated in various variables under investigation will include kinesiophobia physical function anxiety depression physical dysfunction overall impact and symptom intensity
The design of the present study with 3 treatment branches
Condition or disease Fibromyalgia Interventiontreatment Behavioral TAU Experiential Fibrowalk Behavioral TAU Fibrowalk Behavioral TAU virtual
The design of the present study with 3 treatment branches
Condition or disease Fibromyalgia Interventiontreatment Behavioral TAU Experiential Fibrowalk Behavioral TAU Fibrowalk Behavioral TAU virtual
Detailed Description:
The objective of the Experiential Fibrolwalk study is to determine the clinical effectiveness of a new treatment protocol for individuals with fibromyalgia This protocol was developed by identifying predictors of poor response and through collaboration between physiotherapists clinical psychologists and patients The objectives of this 4-month controlled clinical trial are twofold Firstly it aims to assess the impact of a protocol developed collaboratively by clinical therapists and users on the quality of life of individuals with fibromyalgia Secondly it aims to determine the pre-post changes in kinesiophobia physical function anxiety depression physical dysfunction overall impact and symptom intensity Methods and analysis The study will involve 120 fibromyalgia patients recruited from the Central Sensitivity Syndromes Specialized Unit at Vall dHebron Hospitals Rheumatology Service who will be randomly assigned to one of three study groups TAU Experiential Fibrowalk TAU Fibrowalk TAU virtual A comprehensive assessment to collect functional impact depressive-anxiety symptoms physical function fatigue kinesiophobia pain catastrophism impression of changequality of life variables will be conducted pre-intervention at half of the intervention 6 weeks post-intervention 12 weeks and at 3-month follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None