Effectiveness of Experiential Fibrowalk Therapy (EFW)

June 9, 2024 updated by: Hospital Universitari Vall d'Hebron Research Institute

Effectiveness of Experiential Fibrowalk Therapy for Fibromyalgia Based on Pain Science Education, Exercise Therapy, Psychological Support, and Nature Exposure: A Pragmatic Randomized Controlled Trial

The present project will evaluate through a randomised controlled clinical trial with 4-month follow-up, the efficacy in clinical symptoms and quality of life (3-month time horizon) of the multicomponent EXPERIENTIAL FIBROWALK programme in treating individuals diagnosed with fibromyalgia, in compare with original Fibrowalk and virtual Fibrowalk. Pre-post changes will be evaluated in various variables under investigation, will include kinesiophobia, physical function, anxiety, depression, physical dysfunction, overall impact, and symptom intensity.

The design of the present study with 3 treatment branches:

Condition or disease Fibromyalgia Intervention/treatment Behavioral: TAU + Experiential Fibrowalk Behavioral: TAU + Fibrowalk Behavioral: TAU + virtual

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of the Experiential Fibrolwalk study is to determine the clinical effectiveness of a new treatment protocol for individuals with fibromyalgia. This protocol was developed by identifying predictors of poor response and through collaboration between physiotherapists, clinical psychologists, and patients. The objectives of this 4-month controlled clinical trial are twofold. Firstly, it aims to assess the impact of a protocol developed collaboratively by clinical therapists and users on the quality of life of individuals with fibromyalgia. Secondly, it aims to determine the pre-post changes in kinesiophobia, physical function, anxiety, depression, physical dysfunction, overall impact, and symptom intensity. Methods and analysis: The study will involve 120 fibromyalgia patients recruited from the Central Sensitivity Syndromes Specialized Unit at Vall d'Hebron Hospital's Rheumatology Service, who will be randomly assigned to one of three study groups: TAU + Experiential Fibrowalk, TAU + Fibrowalk, TAU + virtual. A comprehensive assessment to collect functional impact, depressive-anxiety symptoms, physical function, fatigue, kinesiophobia, pain catastrophism, impression of change,quality of life variables will be conducted pre-intervention, at half of the intervention (6 weeks), post-intervention (12 weeks), and at 3-month follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experiential FW
Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention) based in no-responder predictive analysis and co-creating process
Behavioral: Experiential FW
Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.) carried out experientially.
Active Comparator: Traditional FW
Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention)
Behavioral: Traditional FW
Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.)
Active Comparator: Online FW
Group treatment protocol of 12 weekly 60 minute sessions (virtual intervention)
Behavioral: Online FW
Traditional Fibrowalk based on Pain Science Education (30 min.) - Cognitive restructuring (30 min.) - Mindfulness techniques (30 min.) - Physical exercise in a natural environment / nature exposure (30 min.) performed virtually.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time Frame: Change from baseline values at 3 months
Standard pharmacological treatment usually provided to patients with fibromyalgia. 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.
Change from baseline values at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from baseline values at 3 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
Change from baseline values at 3 months
Short Form-36 Health Survey (SF-36)
Time Frame: Change from baseline values at 3 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.
Change from baseline values at 3 months
Tampa Scale for kinesiophobia (TSK-11)
Time Frame: Change from baseline values at 3 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.
Change from baseline values at 3 months
Multidimensional Fatigue Inventory (MFI)
Time Frame: Change from baseline values at 3 months
Change from baseline values at 6 months] MFI is used to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Its consists in a 20-item scale designed. Participants utilize a 7-point scale to express the extent to which specific statements accurately reflect their fatigue experiences. Several positively phrased items are reverse-scored. Greater overall scores indicate higher levels of fatigue severity.
Change from baseline values at 3 months
Pain Catastrophising Scale (PCS)
Time Frame: Change from baseline values at 3 months
PCS is used to evaluate catastrophic thoughts associated with pain. It consists of three dimensions (rumination, magnification, and helplessness) of 13 items in total, which are answered on a Likert scale of 5 points. Total scores on each scale range from 0 to 52, with higher scores indicating more catastrophic thoughts
Change from baseline values at 3 months
Psychological inflexibility in pain scale (PIPS)
Time Frame: Change from baseline values at 3 months
A 12-item scale that assesses psychological inflexibility in pain patients and includes two factors: avoidance and cognitive fusion with pain. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). Higher scores indicate greater levels of psychological inflexibility.
Change from baseline values at 3 months
The Patient Global Impression of Change (PGIC)
Time Frame: Change from baseline values at 3 months
Is a measure that has been frequently used as indicators of meaningful overall change [on a 7-point Likert scale, from 1 = "Much better" to 7 = "Much worse"] in treatments for chronic pain.
Change from baseline values at 3 months
Pain Specific Impression of Change (PSIC)
Time Frame: Change from baseline values at 3 months
The PSIC asks about the impression of change in more specific domains than PGIC: physical and social functioning, work-related activities, mood, and pain [on a 7-point Likert scale, from 1 = "Much better" to 7 = "Much worse"].
Change from baseline values at 3 months
Credibility/Expectancy Questionnaire (CEQ) (Adapted version)
Time Frame: Change from baseline values at 3 months
This is a 6-item test used to assess treatment expectations (3 items) as well as credibility (3 items). After the treatment, the test is administered with the questions reformulated in the past tense.
Change from baseline values at 3 months
Adverse effects of treatments
Time Frame: Change from baseline values at 3 months
Ad hoc measure to check for the presence of negative effects of psychological treatments.
Change from baseline values at 3 months
Socio-demographic questionnaire
Time Frame: Change from baseline values at 3 months
Gender, date of birth, marital status, living arrangements, educational level and employment status.
Change from baseline values at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitat Autonoma de Barcelona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Albert Feliu, PhD, Universitat Autonoma de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Experiential Fibrowalk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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