FibromyalgiaNCT04571528
Effectiveness of VIRTUAL FIBROWALK STUDY
A study testing TAU + multicomponent treatment VIRTUAL FIBROWALK, Treatment as Usual (TAU) and TAU + Physiotherapy part of VIRTUAL FIBROWALK in people with Fibromyalgia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The main objective of this study is to analyse the effectiveness of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- TAU + multicomponent treatment VIRTUAL FIBROWALK, Treatment as Usual (TAU) and TAU + Physiotherapy part of VIRTUAL FIBROWALK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 21 Sep 2020to 10 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebrón Hospital
Barcelona
Mayte Serrat, MSc, +34934893891 ext. 6644, mserrat@vhebron.net
Elena Granell, +34934893891, elena.granell@vhir.org
About this study
Official title: Effectiveness of Virtual Multicomponent Treatment for Fibromyalgia: VIRTUAL FIBROWALK STUDY
The main objective of this study is to analyse the effectiveness of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL FIBROWALK treatment in the short- and longterm.
Read the detailed description
This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone and on the comparation of the physiotherapy part of the multicomponent program.
- VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
- Physiotherapy part of VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE) and therapeutic exercise.
- The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance
- Conditions
- Fibromyalgia
- Being tested
- TAU + multicomponent treatment VIRTUAL FIBROWALK, Treatment as Usual (TAU), TAU + Physiotherapy part of VIRTUAL FIBROWALK
- Keywords
- multicomponent treatment, Fibromyalgia, chronic pain, pain neuroscience education, therapeutic exercise, cognitive behavioural therapy, mindfulness, randomized controlled trial
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU + multicomponent treatment VIRTUAL FIBROWALKBehavioural
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): - Pain neuroscience education (15 min.) - Cognitive restructuring (15 min.) - Mindfulness techniques (15 min.) - Physical exercise(15 min.) - Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.
Treatment as Usual (TAU)Behavioural
Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.
TAU + Physiotherapy part of VIRTUAL FIBROWALKBehavioural
Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients: - Pain neuroscience education (30 min.) - Physical exercise(30 min.) - Treatment as Usual (TAU). Standard pharmacological treatment usually provided to patients with fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| TAU + multicomponent treatment VIRTUAL FIBROWALK | Experimental | VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training Receives: Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALK |
| Treatment as Usual (TAU) | Active comparator | Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.patient Receives: Behavioral: Treatment as Usual (TAU) |
| Physiotherapy part of VIRTUA FIBROWALK | Active comparator | The physiotherapy part of the VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE) and therapeutic exercise. Receives: Behavioral: TAU + Physiotherapy part of VIRTUAL FIBROWALK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 months
Secondary outcomes (3)
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.
Measured: Through study completion, an average of 3 months
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.
Measured: Through study completion, an average of 3 months
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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start21 Sep 2020
- Primary completion10 Nov 2021 (estimated)
- Study completion10 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Single-blind, parallel-group, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Marsal, PhD, Principal investigator, Vall d'Hebrón Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571528
- Sponsor's protocol ID
- PR(AG)249/2020
- Status last verified
- Oct 2020
- First submitted
- 25 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Garcia R, Serrat M, Sanabria-Mazo JP, Perez-Aranda A, Almirall M, Delgadillo J, Espelt A, Luciano JV, Nieto R, Feliu-Soler A. Predicting Nonresponse to Multicomponent Treatment in Fibromyalgia: Development and Validation of a Machine Learning Model. Clin J Pain. 2026 May 1;42(5):e1367. doi: 10.1097/AJP.0000000000001367.
PubMed 41766528Serrat M, Albajes K, Navarrete J, Almirall M, Lluch Girbes E, Neblett R, Luciano JV, Moix J, Feliu-Soler A. Effectiveness of two video-based multicomponent treatments for fibromyalgia: The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial. Behav Res Ther. 2022 Nov;158:104188. doi: 10.1016/j.brat.2022.104188. Epub 2022 Sep 8.
PubMed 36116229
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Multicomponent Treatment for Fibromyalgia: VIRTUAL FIBROWALK STUDY
- ClinicalTrials.gov ID
- NCT04571528
- Acronym / sponsor ID
- PR(AG)249/2020
- Conditions
- Fibromyalgia
- Keywords
- multicomponent treatment, Fibromyalgia, chronic pain, pain neuroscience education, therapeutic exercise, cognitive behavioural therapy, mindfulness, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 10 Nov 2021 (estimated)
- Study completion
- 10 Nov 2021 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to analyse the effectiveness of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL FIBROWALK treatment in the short- and longterm.
Detailed description
This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as-usual (TAU) vs. TAU alone and on the comparation of the physiotherapy part of the multicomponent program.
- VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
- Physiotherapy part of VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE) and therapeutic exercise.
- The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment Single-blind, parallel-group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| TAU + multicomponent treatment VIRTUAL FIBROWALK | Experimental | Behavioral: TAU + multicomponent treatment VIRTUAL FIBROWALKVIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.patient |
| Physiotherapy part of VIRTUA FIBROWALK | Active comparator | Behavioral: TAU + Physiotherapy part of VIRTUAL FIBROWALKThe physiotherapy part of the VIRTUAL FIBROWALK is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE) and therapeutic exercise. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAU + multicomponent treatment VIRTUAL FIBROWALKGroup treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): - Pain neuroscience education (15 min.) - Cognitive restructuring (15 min.) - Mindfulness techniques (15 min.) - Physical exercise(15 min.) - Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia. | Behavioural | TAU + multicomponent treatment VIRTUAL FIBROWALK |
| Treatment as Usual (TAU)Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study. | Behavioural | Treatment as Usual (TAU) |
| TAU + Physiotherapy part of VIRTUAL FIBROWALKGroup treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients: - Pain neuroscience education (30 min.) - Physical exercise(30 min.) - Treatment as Usual (TAU). Standard pharmacological treatment usually provided to patients with fibromyalgia. | Behavioural | Physiotherapy part of VIRTUA FIBROWALK |
Primary outcome
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: Through study completion, an average of 3 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.
3 secondary outcomes
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Through study completion, an average of 3 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Through study completion, an average of 3 months
Physical Function of the 36-Item Short Form Survey (SF-36)
Time frame: Through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 41766528Lopez-Garcia R, Serrat M, Sanabria-Mazo JP, Perez-Aranda A, Almirall M, Delgadillo J, Espelt A, Luciano JV, Nieto R, Feliu-Soler A. Predicting Nonresponse to Multicomponent Treatment in Fibromyalgia: Development and Validation of a Machine Learning Model. Clin J Pain. 2026 May 1;42(5):e1367. doi: 10.1097/AJP.0000000000001367.
- Derived from this study: PubMed 36116229Serrat M, Albajes K, Navarrete J, Almirall M, Lluch Girbes E, Neblett R, Luciano JV, Moix J, Feliu-Soler A. Effectiveness of two video-based multicomponent treatments for fibromyalgia: The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial. Behav Res Ther. 2022 Nov;158:104188. doi: 10.1016/j.brat.2022.104188. Epub 2022 Sep 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Marsal, PhD principal investigator
Vall d'Hebrón Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAU + multicomponent treatment VIRTUAL FIBROWALK, Treatment as Usual (TAU) and TAU + Physiotherapy part of VIRTUAL FIBROWALK in people with Fibromyalgia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayte Serrat, MSc (+34934893891 ext. 6644, mserrat@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Fibromyalgia Impact Questionnaire (FIQR) (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571528, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.