Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions in Nature or at Sea

June 20, 2022 updated by: Hospital Universitari Vall d'Hebron Research Institute

Effectiveness of Two Video-based Multicomponent Treatments for Fibromyalgia: The Added Value of Face-to-face Sesions in Nature or at Sea in a Three-arm Randomised Controlled Trial

The aim of this study was to examine the effectiveness of a video-based multicomponent program: the Fibrowalk Virtual plus face-to-face sessions for patients with fibromyalgia (FM) in nature or at sea (FM) compared to Fibrowalk Virtual only.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) in comparation of the Fibrowalk virtual plus face-to-face sessions in the nature or at sea.

VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK combines de same components than Fibrowalk Virtual and added 4 face-to-face sessions (1 per mounth) to resolve doubts and reinforce the main concepts of therapy in the nature or at sea.

The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance

Study Type

Interventional

Enrollment (Actual)

109

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
        • Hospital Vall Hebron

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults from 18 to 75 years-old. 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified - - - ACR diagnostic criteria for fibromyalgia
  • Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

  • Participating in concurrent or past RCTs (previous year).
  • Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.

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 VIRTUAL FIBROWALK at sea
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training. In this arm a 4 face-to-face session at sea will be added to solve doubts and emphasize the most important points of therapy
Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions at sea

Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):

Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) at sea Standard pharmacological treatment usually provided to patients with fibromyalgia.
Active Comparator: TAU + multicomponent treatment VIRTUAL FIBROWALK in nature
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training. In this arm a 4 face-to-face session in nature will be added to solve doubts and emphasize the most important points of therapy
Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions in nature

Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):

Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) 4 face-to-face sessions (1 per mounth) in nature Standard pharmacological treatment usually provided to patients with fibromyalgia.
Active Comparator: TAU + multicomponent treatment VIRTUAL FIBROWALK
VIRTUAL 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 VIRTUAL FIBROWALK

Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order):

Pain neuroscience education (15 min.) Cognitive restructuring (15 min.) Mindfulness techniques (15 min.) Physical exercise(15 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.

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 3 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 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tampa Scale for Kinesiophobia (TSK-11)
Time Frame: Through study completion, an average of 3 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 3 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Through study completion, an average of 3 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 3 months
Physical Function of the 36-Item Short Form Survey (SF-36)
Time Frame: Through study completion, an average of 3 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 3 months
Visual-analogue scale of perceived pain (VAS-Pain)
Time Frame: Through study completion, an average of 3 months
Patients indicate their pain during the last week on a 10 cm line. Total scores range from 0 to 10, where higher scores indicate a greater pain.
Through study completion, an average of 3 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

Universitat Autonoma de Barcelona

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)

April 25, 2022

Primary Completion (Anticipated)

September 25, 2022

Study Completion (Anticipated)

February 23, 2023

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBROWALK NATURE

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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