FibromyalgiaOn&OutNCT05377567
Cost-utility and Immuno-inflammatory Effects of the FIBROWALK in Patients With Fibromyalgia (the On&Out Study)
A study testing TAU + FIBRO-On, TAU + FIBRO-Out and Treatment as Usual (TAU) in people with Fibromyalgia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The present project will evaluate through a randomised controlled clinical trial with 6-month follow-up, the efficacy and cost-utility (6-month time horizon) of the multicomponent FIBROWALK programme in an online (i.e., FIBRO-On) and outdoor (i.e., FIBRO-Out) adjunctive to usual care (HC) format, as compared to HC. 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 + FIBRO-On, TAU + FIBRO-Out and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2022to 20 Nov 2023
- 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
- Patients of both sexes, between 18 and 65 years of age.
- Diagnosis of fibromyalgia according to the ACR 2010/2011 criteria.
- Understanding Spanish.
Who cannot join
- Psychological treatment (within the last year) or current.
- Comorbid presence of severe mental disorder (e.g. schizophrenia) or other terminal clinical conditions or scheduled treatments that may interrupt study follow-up.
- Inability to complete the weekly sessions/modules of the programme on a regular basis.
- Being in litigation with the health system with the aim of obtaining a permanent leave of absence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-utility and Immuno-inflammatory Underpinnings of the FIBROWALK Multicomponent Therapy in Online or Outdoor Format in Fibromyalgia: a Randomised, Controlled Trial (the On&Out Study)
The present project will evaluate through a randomised controlled clinical trial with 6-month follow-up, the efficacy and cost-utility (6-month time horizon) of the multicomponent FIBROWALK programme in an online (i.e., FIBRO-On) and outdoor (i.e., FIBRO-Out) adjunctive to usual care (HC) format, as compared to HC. In order to determine the mechanisms of action of the clinical effects of the interventions studied 6 months after the start of treatment, pre-post changes will be evaluated in various psychological variables considered to be mediators from a theoretical point of view, as well as in immuno-inflammatory markers with evidence of alteration in FM and/or potentially modifiable by the interventions proposed (i.e. IL-6, CXCL8, IL-17A, IL-4, IL-10, high-sensitivity C-reactive protein). In the field of personalised treatment in chronic pain, the design of the present study with 3 treatment branches will also make it possible to establish whether certain patient profiles or baseline psychobiological characteristics can predict the short- and medium-term clinical response to the treatments studied.
Read the detailed description
Introduction: The On\&Out study is aimed at assessing the efficacy, cost-utility and immuno-inflammatory underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative efficacy nor their long-term effects. This study will also evaluate the cost-utility (6-month time-horizon) and the effects in blood biomarkers level of both interventions for the first time. The objectives of this 6-month, randomized, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding FIBRO-On or FIBRO-Out to treatment-as-usual (TAU) for individuals with fibromyalgia; (ii) to identify pre-post differences in levels in blood biomarkers in the three study arms and (iii) to analyze the role of some psychological process variables as mediators of 6-month clinical outcomes. Methods and analysis: Participants will be 225 individuals with fibromyalgia recruited at Vall d'Hebron Institute of Research (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+FIBRO-On vs TAU+FIBRO-Out. A comprehensive assessment to collect functional impact, pain, fatigue, depressive-anxiety symptoms, physical function, kinesiophobia, pain catastrophism, quality of life, costs, and psychological process variables will be conducted pre-intervention, at half of the intervention (6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immuno-inflammatory biomarkers (i.e. IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C reactive protein) and Brain-Derived Neurotrophic Factor will be evaluated in 50% of the sample at pre- and post-treatment. Linear mixed-effects models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.
- Conditions
- Fibromyalgia
- Being tested
- TAU + FIBRO-On, TAU + FIBRO-Out, Treatment as Usual (TAU)
- Keywords
- fibromyalgia, Cost-utility, multicomponent treatment, randomized controlled trial, Biomarkers
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU + FIBRO-OnBehavioural
Group treatment protocol of 12 weekly 60 minute sessions (virtual intervention)
TAU + FIBRO-OutBehavioural
Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention)
Standard pharmacological treatment usually provided to patients with fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| TAU + FIBRO-On | Experimental | FIBRO-On is a virtual multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training Receives: Behavioral: TAU + FIBRO-On |
| TAU + FIBRO-Out | Active comparator | FIBRO-Out is a outdoor multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training Receives: Behavioral: TAU + FIBRO-Out |
| 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: Other: Treatment as Usual (TAU) |
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: Change from baseline values at 6 months
Secondary outcomes (14)
Visual-analogue scale of perceived pain (VAS-Pain)
Patients indicate their pain during the last week on a 10 cm line. Total scores range from 0 to 10, where higher scores indicate a greater pain.
Measured: Change from baseline values at 6 months
Visual-analogue scale of perceived fatigue(VAS-Fatigue)
Patients indicate their fatigue during the last week on a 10 cm line. Patients indicate their pain during the last week on a 10 cm line. Total scores range from 0 to 10, where higher scores indicate a greater fatigue.
Measured: Change from baseline values at 6 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: Change from baseline values at 6 months
Perceived Stress Scale (PSS)
PSS is used to evaluate the stress perceived by people during the last month. This study will use a 4 item version. The response format of this scale is 5-point Likert type. Total scores range from 0 to 16, with higher scores indicating greater perceived stress
Measured: Change from baseline values at 6 months
Short Form-36 Health 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: Change from baseline values at 6 months
EuroQoL-5D (EQ-5D)
An instrument for assessing health-related quality of life. It consists of two parts: the first part assesses the individual's difficulties in relation to mobility, self-care, pain/discomfort and anxiety/depression; and the second part assesses the patient's current perceived health status on an analogue-visual scale from 0 to 100.
Measured: Change from baseline values at 6 months
Client Service Receipt Inventory (CSRI)
Questionnaire for economic evaluation. The version used in this study is designed to retrospectively collect data on the use of health and social services during the previous 6 months.
Measured: Change from baseline values at 6 months
Pain Catastrophising Scale (PCS)
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.
Measured: Change from baseline values at 6 months
Psychological inflexibility in pain scale (PIPS)
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.
Measured: Change from baseline values at 6 months
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: Change from baseline values at 6 months
The Patient Global Impression of Change (PGIC)
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.
Measured: Change from baseline values at 6 months
Pain Specific Impression of Change (PSIC)
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"].
Measured: Change from baseline values at 6 months
Adverse effects of treatments
Ad hoc measure to check for the presence of negative effects of psychological treatments.
Measured: Change from baseline values at 6 months
Socio-demographic questionnaire
Gender, date of birth, marital status, living arrangements, educational level and employment status.
Measured: Change from baseline values at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start15 Sep 2022 (estimated)
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Sponsor
- Investigators
- Albert Feliu, PhD, Principal investigator, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377567
- Sponsor's protocol ID
- ON&OUT
- Acronym
- On&Out
- Status last verified
- Jul 2022
- First submitted
- 4 May 2022
- Last updated
- 28 Jul 2022
- 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 41766528Ferres S, Serrat M, Auer W, Royuela-Colomer E, Almirall M, Lizama-Lefno A, Nijs J, Maes M, Luciano JV, Borras X, Feliu-Soler A. Immune-inflammatory effects of the multicomponent intervention FIBROWALK in outdoor and online formats for patients with fibromyalgia. Brain Behav Immun. 2025 Mar;125:184-197. doi: 10.1016/j.bbi.2024.12.149. Epub 2024 Dec 30.
PubMed 39742894Serrat M, Ferres S, Auer W, Almirall M, Lluch E, D'Amico F, Maes M, Lorente S, Navarrete J, Montero-Marin J, Neblett R, Nijs J, Borras X, Luciano JV, Feliu-Soler A. Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study). Front Physiol. 2022 Nov 10;13:1046613. doi: 10.3389/fphys.2022.1046613. eCollection 2022.
PubMed 36452042
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility and Immuno-inflammatory Underpinnings of the FIBROWALK Multicomponent Therapy in Online or Outdoor Format in Fibromyalgia: a Randomised, Controlled Trial (the On&Out Study)
- ClinicalTrials.gov ID
- NCT05377567
- Acronym / sponsor ID
- On&Out / ON&OUT
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, Cost-utility, multicomponent treatment, randomized controlled trial, Biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona, Ministerio de Ciencia e Innovación, Spain
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 17 May 2022 (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 present project will evaluate through a randomised controlled clinical trial with 6-month follow-up, the efficacy and cost-utility (6-month time horizon) of the multicomponent FIBROWALK programme in an online (i.e., FIBRO-On) and outdoor (i.e., FIBRO-Out) adjunctive to usual care (HC) format, as compared to HC. In order to determine the mechanisms of action of the clinical effects of the interventions studied 6 months after the start of treatment, pre-post changes will be evaluated in various psychological variables considered to be mediators from a theoretical point of view, as well as in immuno-inflammatory markers with evidence of alteration in FM and/or potentially modifiable by the interventions proposed (i.e. IL-6, CXCL8, IL-17A, IL-4, IL-10, high-sensitivity C-reactive protein). In the field of personalised treatment in chronic pain, the design of the present study with 3 treatment branches will also make it possible to establish whether certain patient profiles or baseline psychobiological characteristics can predict the short- and medium-term clinical response to the treatments studied.
Detailed description
Introduction: The On\&Out study is aimed at assessing the efficacy, cost-utility and immuno-inflammatory underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative efficacy nor their long-term effects. This study will also evaluate the cost-utility (6-month time-horizon) and the effects in blood biomarkers level of both interventions for the first time. The objectives of this 6-month, randomized, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding FIBRO-On or FIBRO-Out to treatment-as-usual (TAU) for individuals with fibromyalgia; (ii) to identify pre-post differences in levels in blood biomarkers in the three study arms and (iii) to analyze the role of some psychological process variables as mediators of 6-month clinical outcomes. Methods and analysis: Participants will be 225 individuals with fibromyalgia recruited at Vall d'Hebron Institute of Research (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+FIBRO-On vs TAU+FIBRO-Out. A comprehensive assessment to collect functional impact, pain, fatigue, depressive-anxiety symptoms, physical function, kinesiophobia, pain catastrophism, quality of life, costs, and psychological process variables will be conducted pre-intervention, at half of the intervention (6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immuno-inflammatory biomarkers (i.e. IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C reactive protein) and Brain-Derived Neurotrophic Factor will be evaluated in 50% of the sample at pre- and post-treatment. Linear mixed-effects models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAU + FIBRO-On | Experimental | Behavioral: TAU + FIBRO-OnFIBRO-On is a virtual multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training |
| TAU + FIBRO-Out | Active comparator | Behavioral: TAU + FIBRO-OutFIBRO-Out is a outdoor 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 | Other: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes, between 18 and 65 years of age.
- Diagnosis of fibromyalgia according to the ACR 2010/2011 criteria.
- Understanding Spanish.
Key exclusion criteria (4 listed)
- Psychological treatment (within the last year) or current.
- Comorbid presence of severe mental disorder (e.g. schizophrenia) or other terminal clinical conditions or scheduled treatments that may interrupt study follow-up.
- Inability to complete the weekly sessions/modules of the programme on a regular basis.
- Being in litigation with the health system with the aim of obtaining a permanent leave of absence.
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 + FIBRO-OnGroup treatment protocol of 12 weekly 60 minute sessions (virtual intervention) | Behavioural | TAU + FIBRO-On |
| TAU + FIBRO-OutGroup treatment protocol of 12 weekly 120 minute sessions (outdoor intervention) | Behavioural | TAU + FIBRO-Out |
| Treatment as Usual (TAU)Standard pharmacological treatment usually provided to patients with fibromyalgia. | Other | Treatment as Usual (TAU) |
Primary outcome
Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: Change from baseline values at 6 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.
14 secondary outcomes
Visual-analogue scale of perceived pain (VAS-Pain)
Time frame: Change from baseline values at 6 months
Visual-analogue scale of perceived fatigue(VAS-Fatigue)
Time frame: Change from baseline values at 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline values at 6 months
Perceived Stress Scale (PSS)
Time frame: Change from baseline values at 6 months
Short Form-36 Health Survey (SF-36)
Time frame: Change from baseline values at 6 months
EuroQoL-5D (EQ-5D)
Time frame: Change from baseline values at 6 months
Client Service Receipt Inventory (CSRI)
Time frame: Change from baseline values at 6 months
Pain Catastrophising Scale (PCS)
Time frame: Change from baseline values at 6 months
Psychological inflexibility in pain scale (PIPS)
Time frame: Change from baseline values at 6 months
Tampa Scale for kinesiophobia (TSK-11)
Time frame: Change from baseline values at 6 months
The Patient Global Impression of Change (PGIC)
Time frame: Change from baseline values at 6 months
Pain Specific Impression of Change (PSIC)
Time frame: Change from baseline values at 6 months
Adverse effects of treatments
Time frame: Change from baseline values at 6 months
Socio-demographic questionnaire
Time frame: Change from baseline values at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- 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 39742894Ferres S, Serrat M, Auer W, Royuela-Colomer E, Almirall M, Lizama-Lefno A, Nijs J, Maes M, Luciano JV, Borras X, Feliu-Soler A. Immune-inflammatory effects of the multicomponent intervention FIBROWALK in outdoor and online formats for patients with fibromyalgia. Brain Behav Immun. 2025 Mar;125:184-197. doi: 10.1016/j.bbi.2024.12.149. Epub 2024 Dec 30.
- Derived from this study: PubMed 36452042Serrat M, Ferres S, Auer W, Almirall M, Lluch E, D'Amico F, Maes M, Lorente S, Navarrete J, Montero-Marin J, Neblett R, Nijs J, Borras X, Luciano JV, Feliu-Soler A. Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study). Front Physiol. 2022 Nov 10;13:1046613. doi: 10.3389/fphys.2022.1046613. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Albert Feliu, PhD principal investigator
Universitat Autonoma de Barcelona
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 + FIBRO-On, TAU + FIBRO-Out and Treatment as Usual (TAU) 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 4 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 28 Jul 2022. 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, PhD (+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: Change from baseline values at 6 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 NCT05377567, which also lists 3 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 28 Jul 2022.