Cost-utility and Immuno-inflammatory Effects of the FIBROWALK in Patients With Fibromyalgia (the On&Out Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2023-11-20

Brief Summary

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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 in an online (i.e., FIBRO-On) and outdoor (i.e., FIBRO-Out) adjunctive to usual care (HC) format, as compared to HC. In order to determine the mechanisms of action of the clinical effects of the interventions studied 6 months after the start of treatment, pre-post changes will be evaluated in various psychological variables considered to be mediators from a theoretical point of view, as well as in immuno-inflammatory markers with evidence of alteration in FM and/or potentially modifiable by the interventions proposed (i.e. IL-6, CXCL8, IL-17A, IL-4, IL-10, high-sensitivity C-reactive protein). In the field of personalised treatment in chronic pain, the design of the present study with 3 treatment branches will also make it possible to establish whether certain patient profiles or baseline psychobiological characteristics can predict the short- and medium-term clinical response to the treatments studied.

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Detailed Description

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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: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative efficacy nor their long-term effects. This study will also evaluate the cost-utility (6-month time-horizon) and the effects in blood biomarkers level of both interventions for the first time. The objectives of this 6-month, randomized, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding FIBRO-On or FIBRO-Out to treatment-as-usual (TAU) for individuals with fibromyalgia; (ii) to identify pre-post differences in levels in blood biomarkers in the three study arms and (iii) to analyze the role of some psychological process variables as mediators of 6-month clinical outcomes. Methods and analysis: Participants will be 225 individuals with fibromyalgia recruited at Vall d'Hebron Institute of Research (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+FIBRO-On vs TAU+FIBRO-Out. A comprehensive assessment to collect functional impact, pain, fatigue, depressive-anxiety symptoms, physical function, kinesiophobia, pain catastrophism, quality of life, costs, and psychological process variables will be conducted pre-intervention, at half of the intervention (6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immuno-inflammatory biomarkers (i.e. IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C reactive protein) and Brain-Derived Neurotrophic Factor will be evaluated in 50% of the sample at pre- and post-treatment. Linear mixed-effects models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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TAU + FIBRO-On

FIBRO-On is a virtual multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training

Group Type EXPERIMENTAL

TAU + FIBRO-On

Intervention Type BEHAVIORAL

Group treatment protocol of 12 weekly 60 minute sessions (virtual intervention)

TAU + FIBRO-Out

FIBRO-Out is a outdoor multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training

Group Type ACTIVE_COMPARATOR

TAU + FIBRO-Out

Intervention Type BEHAVIORAL

Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention)

Treatment as Usual (TAU)

Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.patient

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type OTHER

Standard pharmacological treatment usually provided to patients with fibromyalgia.

Interventions

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TAU + FIBRO-On

Group treatment protocol of 12 weekly 60 minute sessions (virtual intervention)

Intervention Type BEHAVIORAL

TAU + FIBRO-Out

Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention)

Intervention Type BEHAVIORAL

Treatment as Usual (TAU)

Standard pharmacological treatment usually provided to patients with fibromyalgia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients of both sexes, between 18 and 65 years of age.
2. Diagnosis of fibromyalgia according to the ACR 2010/2011 criteria.
3. Understanding Spanish.

Exclusion Criteria

1. Psychological treatment (within the last year) or current.
2. Comorbid presence of severe mental disorder (e.g. schizophrenia) or other terminal clinical conditions or scheduled treatments that may interrupt study follow-up.
3. Inability to complete the weekly sessions/modules of the programme on a regular basis.
4. Being in litigation with the health system with the aim of obtaining a permanent leave of absence.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No