Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)

Fibromyalgia Clinical Trial

— FIBROWALK  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284566
• Other study ID #: FIBROWALK STUDY
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 8, 2020

Study information

• Verified date: August 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. fulfil the 2010/2011 American College of Rheumatology (ACR) FM diagnostic criteria. The diagnosis was verified by a rheumatologist (MA) of the CSSSU

2. adults > 18 years old, and

3. provide written informed consent.

Exclusion Criteria:

1. To have a terminal illnesses or programmed interventions that might interrupt the study.

2. 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• TAU + multicomponent treatment FIBROWALK
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)
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.

Locations

Country	Name	City	State
Spain	Vall d'Hebrón Hospital	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Parc Sanitari Sant Joan de Déu, Universitat Autonoma de Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 9 months
Secondary	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.	Through study completion, an average of 9 months
Secondary	Visual Analog Scale (VAS) of the FIQR	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.	Through study completion, an average of 9 months
Secondary	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.	Through study completion, an average of 9 months
Secondary	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.	Through study completion, an average of 9 months