NCT06457633

Effectiveness of Experiential Fibrowalk Therapy

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 Intervention/treatment 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 d'Hebron Hospital's 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 change,quality 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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	Experiential FW	Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.) carried out experientially.
BEHAVIORAL	Traditional FW	Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.)
BEHAVIORAL	Online FW	Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.) performed virtually.

Timeline

• Start date: 2024-05-09
• Primary completion: 2024-07-30
• Completion: 2024-10-30
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: Spain