Clinical trial NCT04284566: Effectiveness of Multicomponent Treatment for Fibromyalgia (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: multicomponent treatment
chronic pain
Fibromyalgia
pain neuroscience education
therapeutic exercise
cognitive behavioural therapy
mindfulness
randomized controlled trial
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
name: Universitat Autonoma de Barcelona
First posted: 2020-02-26
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Through study completion, an average of 9 months
measure: Visual Analog Scale (VAS) of the FIQR
timeFrame: Through study completion, an average of 9 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Through study completion, an average of 9 months
measure: Physical Function of the 36-Item Short Form Survey (SF-36)
timeFrame: Through study completion, an average of 9 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebrón Hospital
Study officials:
affiliation: Vall d'Hebrón Hospital
name: Sara Marsal, PhD
role: STUDY_CHAIR
References:
citation: Serrat M, Sanabria-Mazo JP, Almirall M, Muste M, Feliu-Soler A, Mendez-Ulrich JL, Sanz A, Luciano JV. Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial. Phys Ther. 2021 Dec 1;101(12):pzab200. doi: 10.1093/ptj/pzab200.