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Efficacy of Multicomponent Treatment for Fibromyalgia (FISIOFM) (FISIOFM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04284566
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborators:
Parc Sanitari Sant Joan de Déu
Universitat Autonoma de Barcelona
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
The main objective of this study is to analyse the efficacy of the FISIOFM multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of FISIOFM treatment in the short- and long-term, the research team will seek to identify relevant moderators and mediators of clinical change

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: TAU + multicomponent treatment FISIOFM Behavioral: Treatment as Usual (TAU) Not Applicable

Detailed Description:

This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent program FISIOFM as coadjuvant of treatment-as-usual (TAU) vs. TAU alone.

  • FISIOFM combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
  • 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 self-efficacy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicomponent Treatment in Patients With Fibromyalgia Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness: A Randomized Controlled Trial (FISIOFM)
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: TAU + multicomponent treatment FISIOFM
FISIOFM is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
Behavioral: TAU + multicomponent treatment FISIOFM

Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order):

  • Pain neuroscience education (30 min.)
  • Cognitive restructuring (30min.)
  • Mindfulness techniques (30 min.)
  • Physical exercise(30 min.)
  • Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.

Active Comparator: Treatment as Usual (TAU)
Standard Care. Although there is no treatment considered as the gold standard for fibromyalgia, the standard treatment is usually mainly pharmacological and conforms to the symptomatic profile of each patient.
Behavioral: Treatment as Usual (TAU)
Standard pharmacological treatment usually provided to patients with fibromyalgia.




Primary Outcome Measures :
  1. Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Through study completion, an average of 9 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 :
  1. Tampa Scale for Kinesiophobia (TSK-11) [ Time Frame: Through study completion, an average of 9 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.

  2. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Through study completion, an average of 9 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.

  3. Physical Function of the 36-Item Short Form Survey (SF-36) [ Time Frame: Through study completion, an average of 9 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284566


Contacts
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Contact: Mayte Serrat, MSc +34934893891 ext 6644 mserrat@vhebron.net
Contact: Elena Granell +34934893891 elena.granell@vhir.org

Locations
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Spain
Vall d'Hebrón Hospital Recruiting
Barcelona, Spain, 08035
Contact: Mayte Serrat, MSc    +34934893891 ext 6644    mserrat@vhebron.net   
Contact: Elena Granell    +34934893891    elena.granell@vhir.org   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Parc Sanitari Sant Joan de Déu
Universitat Autonoma de Barcelona
Investigators
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Study Chair: Sara Marsal, PhD Vall d'Hebrón Hospital
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04284566    
Other Study ID Numbers: FISIOFM PR(AG)120/2018
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
multicomponent treatment
chronic pain
Fibromyalgia
pain neuroscience education
therapeutic exercise
cognitive behavioural therapy
mindfulness
randomized controlled trial
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases