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Completed

NCT Number: NCT04284566

Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)

The main objective of this study is to analyse the effectiveness of the FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone.

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Key information

Conditions

Fibromyalgia Chronic Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebrón Hospital

Barcelona, 08035, Spain

About this study

This is a two-arm RCT focused on the potential efficacy of the multicomponent program FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone. FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

The main objective of this RCT was two-fold: (a) To analyse the effectiveness of a 12-week multicomponent treatment as an add-on to Treatment (FIBROWALK) as Usual (TAU) to improve functional impact (primary outcome), as well as pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) compared to TAU; and (b) to explore the baseline differences between responders and non-responders in terms sociodemographic and clinical characteristics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • fulfil the 2010/2011 American College of Rheumatology (ACR) FM diagnostic criteria. The diagnosis was verified by a rheumatologist (MA) of the CSSSU
  • adults > 18 years old, and
  • provide written informed consent.

Exclusion criteria

  • To have a terminal illnesses or programmed interventions that might interrupt the study.
  • No stringent eligibility criteria were established due to the naturalistic nature of the RCT. Excluding patients with lower education or comorbidities might have turned away many patients from our RCT who would otherwise be eligible, that is we put emphasis on external validity. All recruited patients were considered capable of following the multicomponent therapy if they were allocated to it. Lack of adherence to drugs or home activities was not an exclusion criterion given the nature of our trial and we analysed data from all participants who underwent random allocation. Treatment allocation was performed by the clinical trials unit in accordance with computer-generated randomisation sequences.

Treatment and study plan

TAU + multicomponent treatment FIBROWALK

Behavioral

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.

Treatment as Usual (TAU)

Behavioral

Treatment-as-Usual (TAU) consisted of prescribing drugs adapted to the symptomatic profile of each patient. The patients were instructed to continue their baseline medical treatment with no change throughout the 3-month period. In Spain, some counselling about aerobic exercise adjusted to patients' physical limitations is usually provided by first-line clinicians and specialists, but pharmacotherapy it's still the dominant treatment option.

Primary outcomes

  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 outcomes

  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. Visual Analog Scale (VAS) of the FIQR

    Time frame: Through study completion, an average of 9 months

    Visual Analog Scale (VAS) of the FIQR was used to measure fatigue and pain, with scores ranging from 0 to 10. Higher scores indicate greater perceived fatigue and pain, respectively.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Parc Sanitari Sant Joan de Déu
  • Universitat Autonoma de Barcelona

Registry information

Official study title

Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness in Patients With Fibromialgia (FIBROWALK STUDY): A Randomized Controlled Trial

Acronym: FIBROWALK

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2020
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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