Cost-utility and Immuno-inflammatory Effects of the FIBROWALK in Patients With Fibromyalgia (the On&Out Study)
- Conditions
- Fibromyalgia
- Registration Number
- NCT05377567
- Brief 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
- Patients of both sexes, between 18 and 65 years of age.
- Diagnosis of fibromyalgia according to the ACR 2010/2011 criteria.
- Understanding Spanish.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Revised Fibromyalgia Impact Questionnaire (FIQR) 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.
- Secondary Outcome Measures
Name Time Method Socio-demographic questionnaire Change from baseline values at 6 months Gender, date of birth, marital status, living arrangements, educational level and employment status.
Short Form-36 Health Survey (SF-36) Change from baseline values at 6 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.
The Patient Global Impression of Change (PGIC) Change from baseline values at 6 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.
Visual-analogue scale of perceived fatigue(VAS-Fatigue) Change from baseline values at 6 months 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.
Hospital Anxiety and Depression Scale (HADS) Change from baseline values at 6 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.
Visual-analogue scale of perceived pain (VAS-Pain) Change from baseline values at 6 months 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.
Perceived Stress Scale (PSS) Change from baseline values at 6 months 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
Psychological inflexibility in pain scale (PIPS) Change from baseline values at 6 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.
Pain Specific Impression of Change (PSIC) Change from baseline values at 6 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 \[on a 7-point Likert scale, from 1 = "Much better" to 7 = "Much worse"\].
EuroQoL-5D (EQ-5D) Change from baseline values at 6 months 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.
Tampa Scale for kinesiophobia (TSK-11) Change from baseline values at 6 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.
Client Service Receipt Inventory (CSRI) Change from baseline values at 6 months 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.
Pain Catastrophising Scale (PCS) Change from baseline values at 6 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.
Adverse effects of treatments Change from baseline values at 6 months Ad hoc measure to check for the presence of negative effects of psychological treatments.
Trial Locations
- Locations (1)
Hospital Vall Hebron
🇪🇸Barcelona, Spain
Hospital Vall Hebron🇪🇸Barcelona, Spain