Clinical trial NCT05395832: Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions in Nature or at Sea
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
multicomponent treatment
chronic pain
pain neuroscience education
therapeutic exercise
cognitive behavioural therapy
mindfulness
randomized controlled trial
virtual format
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
First posted: 2022-05-27
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Visual-analogue scale of perceived pain (VAS-Pain)
timeFrame: Through study completion, an average of 3 months
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Through study completion, an average of 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Through study completion, an average of 3 months
measure: Physical Function of the 36-Item Short Form Survey (SF-36)
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall Hebron
Study officials:
References: