Effectiveness of eHealth therapeutic education interventions in the management of fibromyalgia: protocol for a systematic review and meta-analysis.

INTRODUCTION: Non-pharmacological approaches have shown promising results in improving symptoms and quality of life of patients with fibromyalgia. However, these approaches may not be easily accessible or feasible for everyone. eHealth interventions may offer a more convenient and cost-effective approach to reach a wider range of patients with fibromyalgia and improve their outcomes. As eHealth tools become more prevalent in clinical practice, it is crucial to understand their effectiveness, limitations and how they can be integrated into standard care to optimise clinical outcomes. This systematic review aims to evaluate the effectiveness of eHealth therapeutic education interventions in managing fibromyalgia. METHODS AND ANALYSIS: Randomised controlled trials including eHealth therapeutic education interventions for individuals ≥18 years old with fibromyalgia, published in English or Spanish, will be retrieved by searching the databases PubMed, CINAHL Plus, EMBASE, Scopus, ISI Web of Science, PsycINFO and the Cochrane Central Register of Controlled Trials. Covidence software will be used for the selection of studies and data extraction. The risk of bias and the certainty of evidence will be assessed using the Cochrane Risk of Bias Assessment tool. We plan to perform a meta-analysis contingent on the number of studies retrieved and the interstudy heterogeneity, which will be explored with I2 statistics. ETHICS AND DISSEMINATION: This protocol and the subsequent systematic review will not collect individual-level data and do not require approval by an ethical committee. We intend to disseminate the study results via peer-reviewed scientific journals and relevant (inter)national conferences. PROSPERO REGISTRATION NUMBER: CRD42022343373.

Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia.

BACKGROUND: Fibromyalgia syndrome (FMS) is a leading cause of functional limitations and disability for which there is no cure. Positive psychological interventions for improving health have received increasing attention, but evidence of the feasibility, acceptability, and impact of such interventions in adult populations with FMS is limited. OBJECTIVES: To describe the rationale and design of a 5-week, online positive affect skills intervention, LARKSPUR: Lessons in Affect Regulation to Keep Stress and Pain UndeR control. METHODS: FMS participants (N = 90) will be randomized to one of two conditions: (1) LARKSPUR or (2) emotion reporting/attention control. LARKSPUR is an online multicomponent intervention that targets eight skills to help foster positive affect: (1) noticing positive events, (2) savoring positive events, (3) identifying personal strengths, (4) behavioral activation to set and work toward attainable goals, (5) mindfulness, (6) positive reappraisal, (7) gratitude, and (8) acts of kindness. The primary outcomes include feasibility (i.e., recruitment, retention, adherence) and acceptability (i.e., helpfulness, usability, satisfaction). Secondary outcomes include pain intensity and pain interference. SIGNIFICANCE: If feasibility and acceptability metrics are met and reductions in pain outcomes are achieved, we will undertake future efficacy and effectiveness trials of LARKSPUR among older adults with FMS. TRIAL REGISTRATION: NCT04869345.

Physical and mental impact of COVID-19 outbreak on fibromyalgia patients.

OBJECTIVES: Acute or chronic stress may trigger or aggravate symptoms of fibromyalgia (FM). We aimed to evaluate the physical and mental health of fibromyalgia patients during the COVID 19 outbreak and identify protective/risk factors. METHODS: An online survey was published in May 2020, following two months of lockdown due to the COVID 19 outbreak, including questionnaires regarding demographic characteristics, access to medical services, anxiety, depression, life approach, coping strategies, perception of social support, widespread pain index (WPI) and symptoms severity scale (SSS), insomnia severity index (ISI) and patient global assessment. RESULTS: Of the 233 patients included in the study, 98% were forced to discontinue complementary or alternative treatments during lockdown. Up to 30% of responders who had been treated with medical cannabis had to stop due to logistic difficulties and this was associated with significantly higher scores of WPI/SSS (p=0.024). Higher levels of anxiety and depression were significantly correlated with higher levels of pain, sleep disorders and subjective perception of deterioration (p=0.00). Higher scores of social support and positive life approach were correlated with less anxiety and depression (p<0.01), lower levels of pain (p<0.05) and less sleep disturbances (p<0.01). Avoidant coping style was strongly associated to higher levels of pain, sleep disturbances, anxiety, depression, and subjective perception of worsening (p<0.01). CONCLUSIONS: Fibromyalgia patients reported adverse mental and physical outcomes during the COVID-19 outbreak. Factors such as stopping current treatments may play a central role. Social support and a positive life approach appear to be protective.

Telemedicine in the Management of Patients with Rheumatic Disease during COVID-19 Pandemic: Incidence of Psychiatric Disorders and Fibromyalgia in Patients with Rheumatoid Arthritis and Psoriatic Arthritis.

The management of patients with immuno-rheumatological diseases has profoundly changed during the COVID-19 pandemic and telemedicine has played an important role in the disease follow-up. In addition to monitoring disease activity and any adverse events, especially infectious events, assessing the psychological situation of the patient can be fundamental. Furthermore, COVID-19 has a serious impact on mental health and, since the beginning of the pandemic, a significantly higher incidence of anxiety disorders and depressive symptoms especially in younger people was observed. In this study, we evaluated the incidence of depressive disorders, anxiety, and fibromyalgia (FM) in our patients with rheumatoid arthritis and psoriatic arthritis during the lockdown period due to the COVID-19 pandemic and we validate the use of telemedicine in the clinical management of these patients. Mental and physical stress during the COVID-19 pandemic can greatly worsen FM symptoms and intensify patients' suffering without a clinical flare of the inflammatory disease for patients affected by rheumatoid arthritis. Telemedicine has allowed us to identify patients who needed a face-to-face approach for therapeutic reevaluation even if not related to a flare of the inflammatory disease. Even if our data does not allow us to draw definitive conclusions regarding the effectiveness of telemedicine as greater than or equal to the standard face-to-face approach, we continue to work by modifying our approach to try to ensure the necessary care in compliance with safety and, optimistically, this tool will become an important part of rheumatic disease management.

Patient Reported Outcome Measures of Sleep Quality in Fibromyalgia: A COSMIN Systematic Review.

Poor sleep quality is a common concern and a troublesome symptom among patients suffering from fibromyalgia. The purpose of this review was to identify and describe the available patient reported outcome measures (PROMs) of sleep quality validated in adult people diagnosed with fibromyalgia. The COSMIN and PRISMA recommendations were followed. An electronic systematized search in the electronic databases PubMed, Scopus, CINAHL Plus, PsycINFO, and ISI Web of Science was carried out. Validation studies of PROMs of sleep quality in fibromyalgia published in English or Spanish were included. The selection of the studies was developed through a peer review process through the online software "COVIDENCE". The quality of the studies was assessed using the COSMIN Risk of Bias checklist. A total of 5 PROMs were found validated in patients with fibromyalgia: (1) Pittsburgh Sleep Quality Index (PSQI), (2) Jenkins Sleep Scale (JSS), (3) Sleep Quality Numeric Rating Scale (SQ-NRS), (4) Medical Outcomes Study-Sleep Scale (MOS-SS), and (5) Fibromyalgia Sleep Diary (FSD). The quality of the evidence was very good and the quality of the results ranged from moderate to high. All the included PROMs, except for the FSD, showed adequate psychometric properties and, therefore, are valid and reliable tools for assessing sleep quality in the context of FM. However, none of the studies analyzed all the psychometric properties of the included PROMs as established in the COSMIN guidelines, highlighting that this is a potential field of research for future investigations.

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.