An interventional study of Experiential FW and Traditional FW in Fibromyalgia, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Treatment
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
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.
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 275 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention) based in no-responder predictive analysis and co-creating process
Behavioral: Experiential FW
Group treatment protocol of 12 weekly 120 minute sessions (outdoor intervention)
Behavioral: Traditional 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.) carried out experientially.
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.)
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.
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.
Time frame: Change from baseline values at 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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 \[on a 7-point Likert scale, from 1 = "Much better" to 7 = "Much worse"\].
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline values at 3 months
Socio-demographic questionnaire
Gender, date of birth, marital status, living arrangements, educational level and employment status.
Time frame: Change from baseline values at 3 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Jul 2024, 2 months after the start.
Of 510 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 2 months is below that.
Counting every sponsor, half of 522 studies reached it within 13 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitari Vall d'Hebron Research Institute →