Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions
Effectiveness of Two Video-based Multicomponent Treatments for Fibromyalgia: The Added Value of Face-to-face Sesions in a Three-arm Randomised Controlled Trial
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedStudy Start
First participant enrolled
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2022
CompletedJune 2, 2022
May 1, 2022
4 months
May 24, 2022
May 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Revised Fibromyalgia Impact Questionnaire (FIQR)
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 Outcomes (4)
Visual-analogue scale of perceived pain (VAS-Pain)
Through study completion, an average of 3 months
Tampa Scale for Kinesiophobia (TSK-11)
Through study completion, an average of 3 months
Hospital Anxiety and Depression Scale (HADS)
Through study completion, an average of 3 months
Physical Function of the 36-Item Short Form Survey (SF-36)
Through study completion, an average of 3 months
Study Arms (3)
TAU + multicomponent treatment VIRTUAL FIBROWALK
EXPERIMENTALVIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
Treatment as Usual (TAU)
ACTIVE COMPARATORTreatment-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
TAU + multicomponent treatment VIRTUAL + 4 face-to-face sessions
ACTIVE COMPARATORVIRTUAL 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
Interventions
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.
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.
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) Standard pharmacological treatment usually provided to patients with fibromyalgia.
Eligibility Criteria
You may qualify if:
- Adults from 18 to 75 years-old.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Vall Hebron
Barcelona, 08035, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
May 31, 2022
Study Start
May 24, 2022
Primary Completion
September 24, 2022
Study Completion
November 24, 2022
Last Updated
June 2, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share