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

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TAU + multicomponent treatment VIRTUAL FIBROWALK
Treatment as Usual (TAU)
TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, multicomponent treatment, chronic pain, pain neuroscience education, therapeutic exercise, cognitive behavioural therapy, mindfulness, randomized controlled trial, virtual format

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Vall HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

TAU + multicomponent treatment VIRTUAL FIBROWALK

Treatment as Usual (TAU)

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

Arm 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-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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual-analogue scale of perceived pain (VAS-Pain)
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.
Tampa Scale for Kinesiophobia (TSK-11)
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)
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.
Physical Function of the 36-Item Short Form Survey (SF-36)
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.

Full Information

First Posted
May 24, 2022
Last Updated
May 30, 2022
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Universitat Autonoma de Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05397080
Brief Title
Effectiveness of Video-based Multicomponent Treatment for Fibromyalgia Plus Face-to-face Sesions
Official Title
Effectiveness of Two Video-based Multicomponent Treatments for Fibromyalgia: The Added Value of Face-to-face Sesions in a Three-arm Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
September 24, 2022 (Anticipated)
Study Completion Date
November 24, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Universitat Autonoma de Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, multicomponent treatment, chronic pain, pain neuroscience education, therapeutic exercise, cognitive behavioural therapy, mindfulness, randomized controlled trial, virtual format

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU + multicomponent treatment VIRTUAL FIBROWALK
Arm Type
Experimental
Arm Description
VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm 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
Arm Title
TAU + multicomponent treatment VIRTUAL + 4 face-to-face sessions
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
TAU + multicomponent treatment VIRTUAL FIBROWALK
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
TAU + multicomponent treatment VIRTUAL FIBROWALK + 4 face-to-face sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Revised Fibromyalgia Impact Questionnaire (FIQR)
Description
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.
Time Frame
Through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Visual-analogue scale of perceived pain (VAS-Pain)
Description
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.
Time Frame
Through study completion, an average of 3 months
Title
Tampa Scale for Kinesiophobia (TSK-11)
Description
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.
Time Frame
Through study completion, an average of 3 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Through study completion, an average of 3 months
Title
Physical Function of the 36-Item Short Form Survey (SF-36)
Description
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.
Time Frame
Through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Vall Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayte Serrat, PhD
Phone
+34934893891
Email
mserrat@vhebron.net
First Name & Middle Initial & Last Name & Degree
Montse Sender
Phone
+34934893891
Email
montse.sender@vhir.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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