Effectiveness of Multicomponent Treatment for Fibromyalgia (FIBROWALK)

NCT04284566 | Completed

• 1 other identifier: FIBROWALK STUDY
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

multicomponent treatment; chronic pain; Fibromyalgia; pain neuroscience education; therapeutic exercise; cognitive behavioural therapy; mindfulness; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Tampa Scale for Kinesiophobia (TSK-11)

  Through study completion, an average of 9 months

• Visual Analog Scale (VAS) of the FIQR

  Through study completion, an average of 9 months

• Hospital Anxiety and Depression Scale (HADS)

  Through study completion, an average of 9 months

• Physical Function of the 36-Item Short Form Survey (SF-36)

  Through study completion, an average of 9 months

Study Arms (2)

TAU + multicomponent treatment FIBROWALK

EXPERIMENTAL

FIBROWALK 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 FIBROWALK

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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. Patients were offered the opportunity to participate in the next wave of group intervention at the end of the study (3 months).

Behavioral: Treatment as Usual (TAU)

Interventions

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.

TAU + multicomponent treatment FIBROWALK

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Parc Sanitari Sant Joan de Déu: collaborator
• Universitat Autonoma de Barcelona: collaborator

Study Sites (1)

Vall d'Hebrón Hospital

Barcelona, 08035, Spain

Location

Related Publications (1)

• 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.

  PMID: 34499174 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Sara Marsal, PhD

  Vall d'Hebrón Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Single-blind, parallel-group, randomized controlled trial

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 26, 2020
• Study Start: November 1, 2018
• Primary Completion: July 8, 2020
• Study Completion: July 8, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)