Clinical trial NCT06457633: Effectiveness of Experiential Fibrowalk Therapy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Multicomponent Treatment
Nature therapy
Mindfulness
Physical therapy
Pain Science Education (PSE)
Psychological Approach
Experiential Therapy
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
First posted: 2024-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, parallel-group, randomized controlled trial
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Adults from 18 to 75 years-old.
* 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Change from baseline values at 3 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline values at 3 months
measure: Short Form-36 Health Survey (SF-36)
timeFrame: Change from baseline values at 3 months
measure: Tampa Scale for kinesiophobia (TSK-11)
timeFrame: Change from baseline values at 3 months
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Change from baseline values at 3 months
measure: Pain Catastrophising Scale (PCS)
timeFrame: Change from baseline values at 3 months
measure: Psychological inflexibility in pain scale (PIPS)
timeFrame: Change from baseline values at 3 months
measure: The Patient Global Impression of Change (PGIC)
timeFrame: Change from baseline values at 3 months
measure: Pain Specific Impression of Change (PSIC)
timeFrame: Change from baseline values at 3 months
measure: Credibility/Expectancy Questionnaire (CEQ) (Adapted version)
timeFrame: Change from baseline values at 3 months
measure: Adverse effects of treatments
timeFrame: Change from baseline values at 3 months
measure: Socio-demographic questionnaire
timeFrame: Change from baseline values at 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron Research Institute
Study officials:
affiliation: Universitat Autonoma de Barcelona
name: Albert Feliu, PhD
role: STUDY_CHAIR
References: