Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions

Not Applicable

• Conditions: Fibromyalgia

• Registration Number: NCT05397080
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

The aim of this study was to examine the effectiveness of two video-based multicomponent programs: Fibrowalk Virtual and the Fibrowalk Virtual plus face-to-face sessions for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only.

The investigators posit that Fibrowalk Virtual plus face-to-face sessions, due to the best results obtained with the Fibrowalk carried out completely face-to-face versus the results of the Fibrowalk Virtual, can help patients with FM to experience more ubiquitous clinical improvement than TAU or Fibrowalk Virtual alone.

Detailed Description

Fibrowalk therapy has shown better results when performed in a natural environment face-to-face. Due to the state of the pandemic, it is necessary to study different forms of approach. It is proposed what number of face-to-face sessions would be necessary to add to the virtual Fibrowalk program to achieve the same or similar effectiveness as in the totally face-to-face format.

This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatmentas- usual (TAU) vs. TAU alone and on the comparation of the FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK.

* 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.

* 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 Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-24
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-30
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-06-02
• Primary Completion: 2022-09-24
• Study Completion: 2022-11-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Revised Fibromyalgia Impact Questionnaire (FIQR)	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.

Secondary Outcome Measures

Name	Time	Method
Visual-analogue scale of perceived pain (VAS-Pain)	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.
Physical Function of the 36-Item Short Form Survey (SF-36)	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.
Tampa Scale for Kinesiophobia (TSK-11)	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.
Hospital Anxiety and Depression Scale (HADS)	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.

Trial Locations

Locations (1)

Hospital Vall Hebron; 🇪🇸 Barcelona, Spain