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)
试验速览
- 阶段
- 不适用
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Revised Fibromyalgia Impact Questionnaire (FIQR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, between 18 and 65 years of age.
- •Diagnosis of fibromyalgia according to the ACR 2010/2011 criteria.
- •Understanding Spanish.
排除标准
- •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.
研究组 & 干预措施
TAU + FIBRO-On
FIBRO-On is a virtual multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
干预措施: TAU + FIBRO-On (Behavioral)
TAU + FIBRO-Out
FIBRO-Out is a outdoor multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
干预措施: TAU + FIBRO-Out (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
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Revised Fibromyalgia Impact Questionnaire (FIQR)
时间窗: 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.
次要结局
- Socio-demographic questionnaire(Change from baseline values at 6 months)
- Short Form-36 Health Survey (SF-36)(Change from baseline values at 6 months)
- The Patient Global Impression of Change (PGIC)(Change from baseline values at 6 months)
- Visual-analogue scale of perceived fatigue(VAS-Fatigue)(Change from baseline values at 6 months)
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline values at 6 months)
- Visual-analogue scale of perceived pain (VAS-Pain)(Change from baseline values at 6 months)
- Perceived Stress Scale (PSS)(Change from baseline values at 6 months)
- Psychological inflexibility in pain scale (PIPS)(Change from baseline values at 6 months)
- Pain Specific Impression of Change (PSIC)(Change from baseline values at 6 months)
- EuroQoL-5D (EQ-5D)(Change from baseline values at 6 months)
- Tampa Scale for kinesiophobia (TSK-11)(Change from baseline values at 6 months)
- Client Service Receipt Inventory (CSRI)(Change from baseline values at 6 months)
- Pain Catastrophising Scale (PCS)(Change from baseline values at 6 months)
- Adverse effects of treatments(Change from baseline values at 6 months)