FibromyalgiaEFWNCT06457633
Effectiveness of Experiential Fibrowalk Therapy
A study testing Experiential FW, Traditional FW and Online FW 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 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Experiential FW, Traditional FW and Online FW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 9 May 2024to 30 Oct 2024
- 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 80 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
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, 08035
About this study
Official title: 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
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Experiential FW, Traditional FW, Online FW
- Keywords
- Fibromyalgia, Multicomponent Treatment, Nature therapy, Mindfulness, Physical therapy, Pain Science Education (PSE), Psychological Approach, Experiential Therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiential FWBehavioural
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.
Traditional FWBehavioural
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.)
Online FWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experiential FW | Experimental | Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention) based in no-responder predictive analysis and co-creating process Receives: Behavioral: Experiential FW |
| Traditional FW | Active comparator | Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention) Receives: Behavioral: Traditional FW |
| Online FW | Active comparator | Group treatment protocol of 12 weekly 60 minute sessions (virtual intervention) Receives: Behavioral: Online FW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Fibromyalgia Impact Questionnaire (FIQR)
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.
Measured: Change from baseline values at 3 months
Secondary outcomes (11)
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 3 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 3 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 3 months
Multidimensional Fatigue Inventory (MFI)
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.
Measured: Change from baseline values at 3 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 3 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 3 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 3 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 3 months
Credibility/Expectancy Questionnaire (CEQ) (Adapted version)
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.
Measured: Change from baseline values at 3 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 3 months
Socio-demographic questionnaire
Gender, date of birth, marital status, living arrangements, educational level and employment status.
Measured: Change from baseline values at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start9 May 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Single-blind, parallel-group, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Responsible party
- Sponsor
- Investigators
- Albert Feliu, PhD, Study chair, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457633
- Sponsor's protocol ID
- Experiential Fibrowalk
- Acronym
- EFW
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Experiential Fibrowalk Therapy for Fibromyalgia Based on Pain Science Education, Exercise Therapy, Psychological Support, and Nature Exposure: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06457633
- Acronym / sponsor ID
- EFW / Experiential Fibrowalk
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Multicomponent Treatment, Nature therapy, Mindfulness, Physical therapy, Pain Science Education (PSE), Psychological Approach, Experiential Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Study start
- 9 May 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 13 Jun 2024 (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 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single-blind, parallel-group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experiential FW | Experimental | Behavioral: Experiential FWGroup treatment protocol of 12 weekly 120 minute sessions (outdoor intervention) based in no-responder predictive analysis and co-creating process |
| Traditional FW | Active comparator | Behavioral: Traditional FWGroup treatment protocol of 12 weekly 120 minute sessions (outdoor intervention) |
| Online FW | Active comparator | Behavioral: Online FWGroup treatment protocol of 12 weekly 60 minute sessions (virtual intervention) |
Who may qualify
- Ages
- 18 to 80 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 |
|---|---|---|
| Experiential FWTraditional 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. | Behavioural | Experiential FW |
| Traditional FWTraditional 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.) | Behavioural | Traditional FW |
| Online FWTraditional 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. | Behavioural | Online FW |
Primary outcome
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.
11 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline values at 3 months
Short Form-36 Health Survey (SF-36)
Time frame: Change from baseline values at 3 months
Tampa Scale for kinesiophobia (TSK-11)
Time frame: Change from baseline values at 3 months
Multidimensional Fatigue Inventory (MFI)
Time frame: Change from baseline values at 3 months
Pain Catastrophising Scale (PCS)
Time frame: Change from baseline values at 3 months
Psychological inflexibility in pain scale (PIPS)
Time frame: Change from baseline values at 3 months
The Patient Global Impression of Change (PGIC)
Time frame: Change from baseline values at 3 months
Pain Specific Impression of Change (PSIC)
Time frame: Change from baseline values at 3 months
Credibility/Expectancy Questionnaire (CEQ) (Adapted version)
Time frame: Change from baseline values at 3 months
Adverse effects of treatments
Time frame: Change from baseline values at 3 months
Socio-demographic questionnaire
Time frame: Change from baseline values at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- 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.
Albert Feliu, PhD study chair
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 Experiential FW, Traditional FW and Online FW 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 13 Jun 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2024.