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

NCT05377567 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2022-07-28

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

BEHAVIORAL

TAU + FIBRO-On

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

BEHAVIORAL

TAU + FIBRO-Out

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

OTHER

Treatment as Usual (TAU)

Standard pharmacological treatment usually provided to patients with fibromyalgia.

Sponsors & Collaborators

  • Universitat Autonoma de Barcelona

    collaborator OTHER

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Albert Feliu, PhD · Universitat Autonoma de Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2023-07-20
Completion
2023-11-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377567 on ClinicalTrials.gov