NCT05377567

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

May 4, 2022

Last Update Submit

July 27, 2022

Conditions

Fibromyalgia

Keywords

fibromyalgiaCost-utilitymulticomponent treatmentrandomized controlled trialBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Revised Fibromyalgia Impact Questionnaire (FIQR)

    The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration.

    Change from baseline values at 6 months

Secondary Outcomes (14)

  • Visual-analogue scale of perceived pain (VAS-Pain)

    Change from baseline values at 6 months

  • Visual-analogue scale of perceived fatigue(VAS-Fatigue)

    Change from baseline values at 6 months

  • Hospital Anxiety and Depression Scale (HADS)

    Change from baseline values at 6 months

  • Perceived Stress Scale (PSS)

    Change from baseline values at 6 months

  • Short Form-36 Health Survey (SF-36)

    Change from baseline values at 6 months

  • +9 more secondary outcomes

Study Arms (3)

TAU + FIBRO-On

EXPERIMENTAL

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

Behavioral: TAU + FIBRO-On

TAU + FIBRO-Out

ACTIVE COMPARATOR

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

Behavioral: TAU + FIBRO-Out

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Other: Treatment as Usual (TAU)

Interventions

TAU + FIBRO-OnBEHAVIORAL

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

TAU + FIBRO-On
TAU + FIBRO-OutBEHAVIORAL

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

TAU + FIBRO-Out
Treatment as Usual (TAU)OTHER

Standard pharmacological treatment usually provided to patients with fibromyalgia.

Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall Hebron

Barcelona, 08035, Spain

Location

Related Publications (2)

  • Ferres S, Serrat M, Auer W, Royuela-Colomer E, Almirall M, Lizama-Lefno A, Nijs J, Maes M, Luciano JV, Borras X, Feliu-Soler A. Immune-inflammatory effects of the multicomponent intervention FIBROWALK in outdoor and online formats for patients with fibromyalgia. Brain Behav Immun. 2025 Mar;125:184-197. doi: 10.1016/j.bbi.2024.12.149. Epub 2024 Dec 30.

    PMID: 39742894DERIVED

  • Serrat M, Ferres S, Auer W, Almirall M, Lluch E, D'Amico F, Maes M, Lorente S, Navarrete J, Montero-Marin J, Neblett R, Nijs J, Borras X, Luciano JV, Feliu-Soler A. Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study). Front Physiol. 2022 Nov 10;13:1046613. doi: 10.3389/fphys.2022.1046613. eCollection 2022.

    PMID: 36452042DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Albert Feliu, PhD

    Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayte Serrat, PhD

CONTACT

+34934893891mserrat@vhebron.net

Montse Sender

CONTACT

+34934893891montse.sender@vhir.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 17, 2022

Study Start

September 15, 2022

Primary Completion

July 20, 2023

Study Completion

November 20, 2023

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)