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

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Fibromyalgia

Treatments: Behavioral: Treatment as Usual (TAU); Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK; Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT05397080

BLENDED FIBROWALK

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 3 patient groups

TAU + multicomponent treatment VIRTUAL FIBROWALK

Experimental group

Description:

VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training

Treatment:

Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK

Treatment as Usual (TAU)

Active Comparator group

Description:

Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.patient

Treatment:

Behavioral: Treatment as Usual (TAU)

TAU + multicomponent treatment VIRTUAL + 4 face-to-face sessions

Active Comparator group

Description:

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 will be added to solve doubts and emphasize the most important points of therapy

Treatment:

Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions