Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK) (FIBROWALK)

August 31, 2021 updated by: Hospital Universitari Vall d'Hebron Research Institute

Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness in Patients With Fibromialgia (FIBROWALK STUDY): A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a two-arm RCT focused on the potential efficacy of the multicomponent program FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone. FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

The main objective of this RCT was two-fold: (a) To analyse the effectiveness of a 12-week multicomponent treatment as an add-on to Treatment (FIBROWALK) as Usual (TAU) to improve functional impact (primary outcome), as well as pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) compared to TAU; and (b) to explore the baseline differences between responders and non-responders in terms sociodemographic and clinical characteristics.

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Vall d'Hebron Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. fulfil the 2010/2011 American College of Rheumatology (ACR) FM diagnostic criteria. The diagnosis was verified by a rheumatologist (MA) of the CSSSU
  2. adults > 18 years old, and
  3. provide written informed consent.

Exclusion Criteria:

  1. To have a terminal illnesses or programmed interventions that might interrupt the study.
  2. No stringent eligibility criteria were established due to the naturalistic nature of the RCT. Excluding patients with lower education or comorbidities might have turned away many patients from our RCT who would otherwise be eligible, that is we put emphasis on external validity. All recruited patients were considered capable of following the multicomponent therapy if they were allocated to it. Lack of adherence to drugs or home activities was not an exclusion criterion given the nature of our trial and we analysed data from all participants who underwent random allocation. Treatment allocation was performed by the clinical trials unit in accordance with computer-generated randomisation sequences.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAU + multicomponent treatment FIBROWALK
FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
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.
Active Comparator: 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. Patients were offered the opportunity to participate in the next wave of group intervention at the end of the study (3 months).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time Frame: Through study completion, an average of 9 months
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.
Through study completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tampa Scale for Kinesiophobia (TSK-11)
Time Frame: Through study completion, an average of 9 months
TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement.
Through study completion, an average of 9 months
Visual Analog Scale (VAS) of the FIQR
Time Frame: Through study completion, an average of 9 months
Visual Analog Scale (VAS) of the FIQR was used to measure fatigue and pain, with scores ranging from 0 to 10. Higher scores indicate greater perceived fatigue and pain, respectively.
Through study completion, an average of 9 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Through study completion, an average of 9 months
HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms.
Through study completion, an average of 9 months
Physical Function of the 36-Item Short Form Survey (SF-36)
Time Frame: Through study completion, an average of 9 months
Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function.
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Parc Sanitari Sant Joan de Déu
Universitat Autonoma de Barcelona

Investigators

  • Study Chair: Sara Marsal, PhD, Vall d'Hebron Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

July 8, 2020

Study Completion (Actual)

July 8, 2020

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

February 23, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBROWALK STUDY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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