Perception of People Diagnosed With Fibromyalgia About Information and Communication Technologies for Chronic Pain Management: Cross-Sectional Survey Study.

BACKGROUND: Chronic pain is prevalent in our society, with conditions such as fibromyalgia being notably widespread. The gold standard for aiding individuals dealing with chronic pain involves interdisciplinary approaches rooted in a biopsychosocial perspective. Regrettably, access to such care is difficult for most of the people in need. Information and communication technologies (ICTs) have been used as a way of overcoming access barriers (among other advantages). OBJECTIVE: This study addressed the little explored area of how individuals with fibromyalgia use and perceive different types of ICTs for pain management. METHODS: A cross-sectional study was conducted using an online survey. This survey was created to assess the use of different ICT tools for pain management, satisfaction with the tools used, and perceived advantages and disadvantages. In addition, data collection encompassed sociodemographic variables and pain-related variables, pain intensity, the impact of pain on daily life activities, and fear of movement/injury beliefs. In total, 265 individuals diagnosed with fibromyalgia completed the survey. RESULTS: Only 2 (0.75%) participants reported not having used any ICT tool for pain management. Among those who used ICT tools, an average of 10.94 (SD 4.48) of 14 different tools were used, with the most used options being instant messaging apps, websites dedicated to managing fibromyalgia, phone calls with health professionals, and online multimedia resources. Satisfaction rates were relatively modest (mean 2.09, SD 0.38) on a scale from 0 to 5, with instant messaging apps, phone calls with health professionals, fibromyalgia management websites, and online multimedia resources being the ones with higher satisfaction. Participants appreciated the ability to receive treatment from home, access to specialized treatment, and using ICTs as a supplement to in-person interventions. However, they also highlighted drawbacks, such as a lack of close contact with health professionals, difficulty expressing emotions, and a lack of knowledge or resources to use ICTs. The use of ICTs was influenced by age and educational background. Additionally, there was a negative correlation between satisfaction with ICT tools and fear of movement/injury. CONCLUSIONS: People with fibromyalgia are prone to using ICTs for pain management, especially those tools that allow them to be in contact with health professionals and have access to online resources. However, there is still a need to improve ICT tools since satisfaction ratings are modest. Moreover, strategies aimed at older people, those with lower levels of education, and those with higher levels of fear of movement/injury can be useful to potentiate the use of ICTs among them.

Study protocol for a three-arm randomized controlled trial investigating the effectiveness, cost-utility, and physiological effects of a fully self-guided digital Acceptance and Commitment Therapy for Spanish patients with fibromyalgia.

Objective: Fibromyalgia (FM) is a prevalent pain syndrome with significant healthcare and societal costs. The aim of the SMART-FM-SP study is to determine the effectiveness, cost-utility, and physiological effects in patients with FM of a digital intervention (STANZA®) currently marketed in the United States, which delivers smartphone-based, fully self-guided Acceptance and Commitment Therapy (Digital ACT) for treating FM-related symptoms. Methods: A single-site, parallel-group, superiority, randomized controlled trial (RCT) will be conducted, including a total of 360 adults diagnosed with FM. Individuals will be randomly allocated (1:1:1) to treatment as usual (TAU), to TAU plus 12 weeks of treatment with Digital ACT, or to TAU plus 12 weeks of treatment with digital symptom tracking (i.e. FibroST). Participants will be assessed at baseline, post-treatment, and 6-month follow-up. An intention-to-treat analysis using linear mixed models will be computed to analyze the effects of Digital ACT on functional impairment (primary outcome), as measured by the Fibromyalgia Impact Questionnaire Revised at 6 months from the inception of the treatment. Secondary outcomes include impression of change, symptoms of distress, pain catastrophising, quality of life, cost-utility, and selected biomarkers (cortisol and cortisone, immune-inflammatory markers, and FKBP5 gene polymorphisms). The role of ACT-related processes of change will be tested with path analyses. Conclusions: This study is the first RCT that tests Digital ACT for Spanish patients with FM. Results will be important not only for patients and clinicians, but also for policy makers by examining the cost-utility of the app in a public healthcare context.

Restrictive Diets in Patients with Fibromyalgia: State of the Art.

Around 20-30% of Fibromyalgia patients modify their dietary habits after diagnosis, including avoiding certain food groups such as cereals. In this systematic review, we used the PRISMA guidelines to select the main studies that have evaluated the effectiveness of restrictive diets, including elimination and vegetarian diets, in patients with Fibromyalgia. Data on vegetarian/vegan diets are more consistent than data on elimination diets due to higher quality and better results of the published studies. Although the results are favorable in most of the studies, their heterogenicity and the scarce and low quality of the evidence (small number of patients included, often non-randomized and uncontrolled studies and multiple confounding factors and biases) does not allow for a positive recommendation about these restrictive diets in Fibromyalgia patients. Several factors other than food restriction could influence the symptomatic and functional improvements observed after restrictive diets, such as the placebo effect, weight loss that often occurs, coexistence with gastrointestinal diseases and positive effects of unrestricted foods. We must advance more and improve in our knowledge of the effectiveness of restrictive diets and variables related to them before recommending them systematically to all patients with Fibromyalgia. Randomized, placebo-controlled trials with large sample sizes, longer follow-up periods and standardized outcome measures that explore predictors of dietary response are needed to better understand the relationship between Fibromyalgia and nutrition.

Women living with fibromyalgia during the COVID-19 pandemic: A qualitative study.

We explored the experiences of women with fibromyalgia during the COVID-19 pandemic from a qualitative approach by interviewing eighteen women. We identified seven main themes after performing a thematic analysis: pain description, pain triggers, impact, coping strategies, treatment for pain, pain onset and general situation. In general, pain worsened during the pandemic, and activity restrictions and changes in social interactions were particularly related with that. Pain negatively impacted different life domains: mental health, physical health, cognitive status, social activities and daily activities. Coping strategies varied slightly after the pandemic outbreak, and treatment was interrupted for some women. Results reflect that the pandemic was challenging for women living with fibromyalgia, and highlight the need to develop specific interventions for them in the context of potential future health emergencies.

Definición de la fibromialgia / Definition of fibromyalgia

El artículo define brevemente la fibromialgia dentro de un contexto más amplio incluyendo las raíces históricas del concepto y su posible etiología, así como su interpretación dentro de los modelos biopsicosociales más actuales, con implicaciones terapéuticas de alto interés.(AU)

Effectiveness of an online multicomponent program (FATIGUEWALK) for chronic fatigue syndrome: A randomized controlled trial.

OBJECTIVE: This study aimed to evaluate the effectiveness of an online multicomponent intervention called FATIGUEWALK (FaW) compared to treatment as usual (TAU) in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). METHOD: FaW included pain neuroscience education, therapeutic exercise, cognitive restructuring, and mindfulness training. A total of 428 patients with CFS/ME were randomized into two study arms: online FaW plus TAU versus TAU alone. A single-blinded randomized controlled trial was conducted. Validated patient-reported outcome measures of fatigue, pain, anxiety, depression, and physical function were collected at baseline and posttreatment, following the FaW intervention, which lasted 12 weeks. RESULTS: Statistically significant improvements (with small-to-moderate effect sizes) were observed in online FaW versus TAU alone with respect to multidimensional aspects of fatigue (Cohen's d ranging from 0.25 to 0.73) and most secondary outcomes (pain and fatigue intensity, depressive and anxious symptomatology, functional impairment, kinesiophobia, physical functioning). The absolute risk reduction in FaW versus TAU was 19%, 95% confidence interval (CI) [12.19, 25.80] with number needed to treat = 6, 95% CI [3.9, 8.2]. Overall, similar clinical improvements were observed in sensitivity analyses including a subgroup of patients without comorbidity with fibromyalgia (n = 70). CONCLUSIONS: This is the first study to assess the short-term effectiveness of an online multicomponent intervention added to TAU, compared to TAU alone, for the management of CFS/ME. Further trials, including active control groups with an equivalent treatment dose, and assessing the long-term effectiveness of the online FaW, are warranted. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Definición del dolor / Definition of pain

El presente trabajo aborda los diferentes aspectos implicados en la definición del dolor. Por un lado, explora los antecedentes históricos del término en medicina, así como la visión del dolor como una experiencia adaptativa pero también como un reto terapéutico. Se destaca la definición del dolor de la Asociación Internacional para el Estudio del Dolor - IASP (2020). Finalmente, desde una aproximación biopsicosocial al dolor, se destacan los peligros y las debilidades del modelo biomédico en el abordaje del dolor persistente (crónico).(AU)

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).

Introduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological 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 effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre-post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes. Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d'Hebron University Hospital (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 impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed. Ethics and dissemination: This study has been approved by the Ethics Committee of the Vall d'Hebron Institute of Research. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities. Trial registration number NCT05377567 (clinicaltrials.gov).

Effectiveness of two video-based multicomponent treatments for fibromyalgia: The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial.

BACKGROUND/OBJECTIVES: The aim of this study was to examine the effectiveness of two video-based multicomponent programs (FIBROWALK) and the Multicomponent Physiotherapy Program (MPP) for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only. We posit that FIBROWALK, due to inclusion of specific psychological ingredients (cognitive restructuring and mindfulness), can produce additional clinical benefits when compared to TAU or MPP alone. METHODS: A total of 330 patients with FM were recruited and randomly allocated (1:1:1) to TAU only, TAU + FIBROWALK, or TAU + MPP. FIBROWALK and MPP consisted of weekly videos on pain neuroscience education, therapeutic exercise and self-management patient education, but only the FIBROWALK intervention provided cognitive restructuring and mindfulness. Both programs were structurally equivalent. Between-group differences in functional impairment, pain, kinesiophobia, anxious-depressive symptoms and physical functioning were evaluated at post-treatment following Intention-To-Treat and complete-case approaches. RESULTS: Compared to TAU only, individuals in the FIBROWALK arm showed larger improvements in all clinical outcomes; similarly, participants in the MPP program also showed greater improvements in functional impairment, perceived pain, kinesiophobia, depressive symptoms compared to TAU only. The FIBROWALK intervention showed superior effects in improving pain, anxiety and depressive symptoms and physical functioning compared to MPP. CONCLUSIONS: This RCT supports the short-term effectiveness of the video-based multicomponent programs FIBROWALK and MPP for FM and provides evidence that cognitive-behavioural and mindfulness-based techniques can be clinically useful in the context of physiotherapeutic multicomponent treatment programs. TRIAL REGISTRATION NUMBER: NCT04571528.

Efficacy of the FIBROWALK Multicomponent Program Moved to a Virtual Setting for Patients with Fibromyalgia during the COVID-19 Pandemic: A Proof-of-Concept RCT Performed Alongside the State of Alarm in Spain.

FIBROWALK is a multicomponent program including pain neuroscience education, therapeutic exercise, cognitive behavioral therapy and mindfulness training that has recently been found to be effective in patients with fibromyalgia (FM). This RCT started before the COVID-19 pandemic and was moved to a virtual format (i.e., online videos) when the lockdown was declared in Spain. This study is aimed to evaluate the efficacy of a virtual FIBROWALK compared to Treatment-As-Usual (TAU) in patients with FM during the first state of alarm in Spain. A total of 151 patients with FM were randomized into two study arms: FIBROWALK plus TAU vs. TAU alone. The primary outcome was functional impairment. Secondary outcomes were kinesiophobia, anxiety and depressive symptomatology, and physical functioning. Differences between groups at post-treatment assessment were analyzed using Intention-To-Treat (ITT) and completer approaches. Baseline differences between clinical responders and non-responders were also explored. Statistically significant improvements with small-to-moderate effect sizes were observed in FIBROWALK+TAU vs. TAU regarding functional impairment and most secondary outcomes. In our study, the NNT was 5, which was, albeit modestly, indicative of an efficacious intervention. The results of this proof-of-concept RCT preliminarily support the efficacy of virtual FIBROWALK in patients with FM during the Spanish COVID-19 lockdown.

Effectiveness of a Multicomponent Treatment Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioral Therapy, and Mindfulness in Patients With Fibromyalgia (FIBROWALK Study): A Randomized Controlled Trial.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of a 12-week multicomponent treatment based on pain neuroscience education, therapeutic exercise, cognitive behavioral therapy, and mindfulness-in addition to treatment as usual-compared with treatment as usual only in patients with fibromyalgia. METHODS: This randomized controlled trial involved a total of 272 patients who were randomly assigned to either multicomponent treatment (n = 135) or treatment as usual (n = 137). The multicomponent treatment (2-hour weekly sessions) was delivered in groups of 20 participants. Treatment as usual was mainly based on pharmacological treatment according to the predominant symptoms. Data on functional impairment using the Revised Fibromyalgia Impact Questionnaire as the primary outcome were collected as were data for pain, fatigue, kinesiophobia, physical function, anxiety, and depressive symptoms (secondary outcomes) at baseline, 12 weeks, and, for the multicomponent group only, 6 and 9 months. An intention-to-treat approach was used to analyze between-group differences. Baseline differences between responders (>20% Revised Fibromyalgia Impact Questionnaire reduction) and nonresponders also were analyzed, and the number needed to treat was computed. RESULTS: At posttreatment, significant between-group differences with a large effect size (Cohen d > 0.80) in favor of the multicomponent treatment were found in functional impairment, pain, kinesiophobia, and physical function, whereas differences with a moderate size effect (Cohen d > 0.50 and <0.80) were found in fatigue, anxiety, and depressive symptoms. Nonresponders scored higher on depressive symptoms than responders at baseline. The number needed to treat was 2 (95% CI = 1.7-2.3). CONCLUSION: Compared with usual care, there was evidence of short-term (up to 3 months) positive effects of the multicomponent treatment for fibromyalgia. Some methodological shortcomings (eg, absence of follow-up in the control group and monitoring of treatment adherence, potential research allegiance) preclude robust conclusions regarding the proposed multicomponent program. IMPACT: Despite some methodological shortcomings in the design of this study, the multicomponent therapy FIBROWALK can be considered a novel and effective treatment for patients with fibromyalgia. Physical therapists should detect patients with clinically relevant depression levels prior to treatment because depression can buffer treatment effects. LAY SUMMARY: Fibromyalgia is prevalent and can be expensive to treat. This multicomponent treatment could significantly improve the core symptoms of fibromyalgia compared with usual treatment.

Effectiveness of a Multicomponent Treatment for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): A Pragmatic Randomized Controlled Trial.

A recent study (FIBROWALK has supported the effectiveness of a multicomponent treatment based on pain neuroscience education (PNE), exercise therapy (TE), cognitive behavioral therapy (CBT), and mindfulness in patients with fibromyalgia. The aim of the present RCT was: (a) to analyze the effectiveness of a 12-week multicomponent treatment (nature activity therapy for fibromyalgia, NAT-FM) based on the same therapeutic components described above plus nature exposure to maximize improvements in functional impairment (primary outcome), as well as pain, fatigue, anxiety-depression, physical functioning, positive and negative affect, self-esteem, and perceived stress (secondary outcomes), and kinesiophobia, pain catastrophizing thoughts, personal perceived competence, and cognitive emotion regulation (process variables) compared with treatment as usual (TAU); (b) to preliminarily assess the effects of the nature-based activities included (yoga, Nordic walking, nature photography, and Shinrin Yoku); and (c) to examine whether the positive effects of TAU + NAT-FM on primary and secondary outcomes at post-treatment were mediated through baseline to six-week changes in process variables. A total of 169 FM patients were randomized into two study arms: TAU + NAT-FM vs. TAU alone. Data were collected at baseline, at six-week of treatment, at post-treatment, and throughout treatment by ecological momentary assessment (EMA). Using an intention to treat (ITT) approach, linear mixed-effects models and mediational models through path analyses were computed. Overall, TAU + NAT-FM was significantly more effective than TAU at posttreatment for the primary and secondary outcomes evaluated, as well as for the process variables. Moderate-to-large effect sizes were achieved at six-weeks for functional impairment, anxiety, kinesiophobia, perceived competence, and positive reappraisal. The number needed to treat (NNT) was 3 (95%CI = 1.6-3.2). The nature activities yielded an improvement in affective valence, arousal, dominance, fatigue, pain, stress, and self-efficacy. Kinesiophobia and perceived competence were the mediators that could explain a significant part of the improvements obtained with TAU + NAT-FM treatment. TAU + NAT-FM is an effective co-adjuvant multicomponent treatment for improving FM-related symptoms.

Incidence of COVID-19 in a cohort of adult and paediatric patients with rheumatic diseases treated with targeted biologic and synthetic disease-modifying anti-rheumatic drugs.

Objectives: To investigate the incidence of COVID-19 in a cohort of adult and paediatric patients with rheumatic diseases receiving targeted biologic and synthetic disease modifying anti-rheumatic drugs (tDMARDs) and to explore the possible effect of these treatments in the clinical expression of COVID-19. Methods: A cross-sectional study comprising of a telephone survey and electronic health records review was performed including all adult and paediatric patients with rheumatic diseases treated with tDMARDs in a large rheumatology tertiary centre in Barcelona, Spain. Demographics, disease activity, COVID-19 related symptoms and contact history data were obtained from the start of the 2020 pandemic. Cumulative incidence of confirmed cases (SARS-CoV-2 positive PCR test) was compared to the population estimates for the same city districts from a governmental COVID-19 health database. Suspected cases were defined following WHO criteria and compared to those without compatible symptoms. Results: 959 patients with rheumatic diseases treated with tDMARDs were included. We identified 11 confirmed SARS-CoV-2 positive cases in the adult cohort and no confirmed positive cases in the paediatric cohort. COVID-19 incidence rates of the rheumatic patient cohort were very similar to that of the general population [(0.48% (95% CI 0.09 to 0.87%)] and [0.58% (95% CI 0.56 to 0.60%)], respectively. We found significant differences in tDMARDs proportions between the suspected and non-suspected cases (p=0.002). Conclusion: Adult and paediatric patients with rheumatic diseases on tDMARDs do not seem to present a higher risk of COVID-19 or a more severe disease outcome when compared to general population.

Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial.

The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted.