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Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)

NCT04284566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2021-09-05

No results posted yet for this study

Summary

The main objective of this study is to analyse the effectiveness of the FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone.

Conditions

  • Fibromyalgia

Interventions

BEHAVIORAL

TAU + multicomponent treatment FIBROWALK

Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order): * Pain neuroscience education (30 min.) * Cognitive restructuring (30min.) * Mindfulness techniques (30 min.) * Physical exercise(30 min.) * Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.

BEHAVIORAL

Treatment as Usual (TAU)

Treatment-as-Usual (TAU) consisted of prescribing drugs adapted to the symptomatic profile of each patient. The patients were instructed to continue their baseline medical treatment with no change throughout the 3-month period. In Spain, some counselling about aerobic exercise adjusted to patients' physical limitations is usually provided by first-line clinicians and specialists, but pharmacotherapy it's still the dominant treatment option.

Sponsors & Collaborators

  • Parc Sanitari Sant Joan de Déu

    collaborator OTHER

  • Universitat Autonoma de Barcelona

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Sara Marsal, PhD · Vall d'Hebrón Hospital

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
2018-11-01
Primary Completion
2020-07-08
Completion
2020-07-08

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 NCT04284566 on ClinicalTrials.gov