Report from the Hand Osteoarthritis Working Group at OMERACT 2018: Update on Core Instrument Set Development

Objective: To evaluate hand osteoarthritis tools for core instrument set development. Methods: For OMERACT 2018, a systematic literature review and advances in instrument validation were presented. Results: Visual analog and numerical rating scales were considered valuable for pain and patient’s global assessment, despite heterogeneous phrasing and missing psychometric evidence for some aspects. The Modified Intermittent and Constant Osteoarthritis Pain scale was lacking evidence. The Michigan Hand Outcomes Questionnaire had advantages above other pain/function questionnaires. The Hand Mobility in Scleroderma scale was valid, although responsiveness was questioned. Potential joint activity instruments were evaluated. Conclusion: The development of the core instrument set is progressing, and a research agenda was also developed

International, multidisciplinary Delphi consensus recommendations on non-pharmacological interventions for fibromyalgia

Funding Information: The Republic of Turkey Ministry of National Education for the PhD studentship. Publisher Copyright: © 2022 The Author(s)Objectives: To develop evidence-based expert recommendations for non-pharmacological treatments for pain, fatigue, sleep problems, and depression in fibromyalgia. Methods: An international, multidisciplinary Delphi exercise was conducted. Authors of EULAR and the Canadian Fibromyalgia Guidelines Group, members of the American Pain Society and clinicians with expertise in fibromyalgia were invited. Participants were asked to select non-pharmacological interventions that could be offered for specific fibromyalgia symptoms and to classify them as either core or adjunctive treatments. An evidence summary was provided to aid the decision making. Items receiving >70% votes were accepted, those receiving <30% votes were rejected and those obtaining 30-70% votes were recirculated for up to two additional rounds. Results: Seventeen experts participated (Europe (n = 10), North America (n = 6), and Israel (n = 1)) in the Delphi exercise and completed all three rounds. Aerobic exercise, education, sleep hygiene and cognitive behavioural therapy were recommended as core treatments for all symptoms. Mind-body exercises were recommended as core interventions for pain, fatigue and sleep problems. Mindfulness was voted core treatment for depression, and adjunctive treatment for other symptoms. Other interventions, namely music, relaxation, hot bath, and local heat were voted as adjunctive treatments, varying between symptoms. Conclusions: This study provided evidence-based expert consensus recommendations on non-pharmacological treatments for fibromyalgia that may be used to individualise treatments in clinical practice targeting the diverse symptoms associated with fibromyalgia.publishersversionepub_ahead_of_prin

Identifying key elements of non-pharmacological treatment package for fibromyalgia: Evidence synthesis and Delphi exercise

Background Fibromyalgia (FM) is a common condition that manifests with chronic widespread pain, fatigue, non-restorative sleep and cognitive dysfunction. FM impacts directly on health and quality of life (QoL) and is associated with a large economic burden on health care systems. Its diagnosis and management are often challenging due to heterogeneous manifestations. Non-pharmacological interventions are recommended as first-line treatment for FM. However, there are no evidence-based recommendations for which intervention(s) to offer patients with different manifestations of FM, and, which of these should be offered as core and adjunctive treatments within a package of care. Objectives: The overall purpose of the research project was to identify key elements of a non-pharmacological treatment package for FM. The study had the following objectives: 1. To estimate the efficacy of non-pharmacologic treatments for FM using a systematic review with conventional meta-analysis (CMA) approach. 2. To estimate the relative efficacy of non-pharmacologic interventions for FM using a Bayesian network meta-analysis (NMA) approach. 3. To select the most efficacious interventions for different outcomes of FM using a Delphi exercise (consensus building) approach. Methods Two meta-analytical techniques, CMA and NMA, were conducted in the first stage of the project. Following this, a Delphi exercise was undertaken. CMA and NMA: MEDLINE, EMBASE, AMED, PsycINFO, CINAHL, Web of Science were systematically searched from their dates of inception until September 2018. In addition, the first 100 articles on Google Scholar were included. Randomised controlled trials (RCTs) comparing any non-pharmacological intervention versus another non-pharmacological intervention, usual care, no treatment, waiting list or placebo/sham treatments in patients with FM aged >16 were included without language restriction. The composite score of the FM Impact Questionnaire (FIQ) was the primary outcome of interest. Pain, fatigue, sleep and depression were assessed as secondary outcomes. Usual care/placebo controlled RCTs were pooled in random-effects conventional meta-analyses (CMA) and standardised mean difference (SMD) and 95% confidence interval (CI) were calculated. Bayesian network meta-analysis (NMA) compared the treatments using usual care as a common comparator. SMDs and 95% credible intervals (CrIs) were estimated between interventions. Direct and indirect evidence were pooled using the random effect model. Modified Cochrane‘s tool was used to assess risk of bias. Publication bias was assessed using funnel plot and Egger’s test. Delphi exercise: A three-stage Delphi exercise was designed and potential panel members were selected from experts in FM identified from the author list of international FM guidelines (EULAR, Canadian guidelines) and local clinician advice. In the first round Delphi survey, participants were asked to confirm their professional details, select interventions that they thought should be offered to people with FM, and to rate these interventions as core or adjunctive treatment for the four key symptoms of FM (pain, fatigue, sleep disturbance and depression). They were provided a summary of current research evidence from CMA to support their decision-making. Surveys for the second and third rounds were prepared based on the items which did not achieve the consensus threshold of 70%. Results 16,251 studies were identified and 187 RCTs (n=13,454 participants) met all inclusion criteria for the systematic review. In total, 21 non-pharmacological interventions were evaluated. CMA: 148 RCTs (n=9,598) were included in the CMA. Exercise was the only intervention associated with significant improvements for all five outcomes [FIQ (SMD=-0.67; 95% CI -0.89, -0.45), pain (-0.84; 95% CI -1.13, -0.55), fatigue (-0.88; 95% CI -1.39, -0.37), sleep (-0.55; 95% CI -1.04, -0.06) and depression (-0.55; 95% CI -0.82, -0.28)]. Psychological treatments including cognitive behavioural therapy (CBT) and mindfulness were significantly more efficacious than usual care for FIQ, pain and depression but showed no improvement for fatigue and sleep. All exercise types were effective at relieving pain. Mind body and strengthening exercises were effective at improving fatigue, while aerobic and strengthening exercises were effective at improving sleep. All exercise types except for aerobic exercise improved depression. NMA: 78 studies (n = 5,639 participants) met the inclusion criteria. While multidisciplinary treatment (MDT) was the best for improving pain [-1.28 (-1.84, -0.72)], sleep [-1.14 (-2.38, 0.07)] and depression [-1.20 (-1.99, -0.46)], balneotherapy and exercise were the most effective treatments for overall FIQ [-1.06 (-1.52, -0.62)] and fatigue [-0.75 (-1.35, -0.25)] respectively. Data from 47 exercise trials (n = 3,271 participants) were also analysed to examine the relative efficacy of different exercise types. Of the different types of exercise, strengthening showed the greatest benefits for FIQ [-0.76 (-1.39, -0.15)], pain [-0.94 (-1.58, -0.29)] and depression [-0.83 (-1.53, -0.14)], whereas aerobic exercise was the best for fatigue [-0.98 (-2.33, 0.18)] and sleep disorders [-0.96 (-2.08, 0.13)]. Delphi exercise: Of 48 invitees, 17 agreed to participate. These included seven rheumatologists, two physiotherapists, one psychologist, one nurse and six people from other professional backgrounds, specifically physical medicine and rehabilitation, neurology, immunology and public health. Response and completion rates for the 17 participants were 100%. Aerobic exercise, education, sleep hygiene, CBT, mindfulness, mind-body exercise and stress management were recommended for all four outcomes. Also, all these interventions except for mindfulness were voted as core in the management of FM. Conclusions Several non-pharmacological interventions are beneficial for FM. Some interventions appear particularly efficacious for certain FM manifestations. The results of this study should be used to guide the selection of the most beneficial interventions according to the predominant symptom(s) of the individual patient. Further research is required to evaluate if such a strategy better improves outcomes in FM patients. Registration The protocol for the systematic review of non-pharmacological interventions for FM has been registered with the international prospective register of systematic reviews (PROSPERO), registration number CRD42017074982

Identifying key elements of non-pharmacological treatment package for fibromyalgia: Evidence synthesis and Delphi exercise

Background Fibromyalgia (FM) is a common condition that manifests with chronic widespread pain, fatigue, non-restorative sleep and cognitive dysfunction. FM impacts directly on health and quality of life (QoL) and is associated with a large economic burden on health care systems. Its diagnosis and management are often challenging due to heterogeneous manifestations. Non-pharmacological interventions are recommended as first-line treatment for FM. However, there are no evidence-based recommendations for which intervention(s) to offer patients with different manifestations of FM, and, which of these should be offered as core and adjunctive treatments within a package of care. Objectives: The overall purpose of the research project was to identify key elements of a non-pharmacological treatment package for FM. The study had the following objectives: 1. To estimate the efficacy of non-pharmacologic treatments for FM using a systematic review with conventional meta-analysis (CMA) approach. 2. To estimate the relative efficacy of non-pharmacologic interventions for FM using a Bayesian network meta-analysis (NMA) approach. 3. To select the most efficacious interventions for different outcomes of FM using a Delphi exercise (consensus building) approach. Methods Two meta-analytical techniques, CMA and NMA, were conducted in the first stage of the project. Following this, a Delphi exercise was undertaken. CMA and NMA: MEDLINE, EMBASE, AMED, PsycINFO, CINAHL, Web of Science were systematically searched from their dates of inception until September 2018. In addition, the first 100 articles on Google Scholar were included. Randomised controlled trials (RCTs) comparing any non-pharmacological intervention versus another non-pharmacological intervention, usual care, no treatment, waiting list or placebo/sham treatments in patients with FM aged >16 were included without language restriction. The composite score of the FM Impact Questionnaire (FIQ) was the primary outcome of interest. Pain, fatigue, sleep and depression were assessed as secondary outcomes. Usual care/placebo controlled RCTs were pooled in random-effects conventional meta-analyses (CMA) and standardised mean difference (SMD) and 95% confidence interval (CI) were calculated. Bayesian network meta-analysis (NMA) compared the treatments using usual care as a common comparator. SMDs and 95% credible intervals (CrIs) were estimated between interventions. Direct and indirect evidence were pooled using the random effect model. Modified Cochrane‘s tool was used to assess risk of bias. Publication bias was assessed using funnel plot and Egger’s test. Delphi exercise: A three-stage Delphi exercise was designed and potential panel members were selected from experts in FM identified from the author list of international FM guidelines (EULAR, Canadian guidelines) and local clinician advice. In the first round Delphi survey, participants were asked to confirm their professional details, select interventions that they thought should be offered to people with FM, and to rate these interventions as core or adjunctive treatment for the four key symptoms of FM (pain, fatigue, sleep disturbance and depression). They were provided a summary of current research evidence from CMA to support their decision-making. Surveys for the second and third rounds were prepared based on the items which did not achieve the consensus threshold of 70%. Results 16,251 studies were identified and 187 RCTs (n=13,454 participants) met all inclusion criteria for the systematic review. In total, 21 non-pharmacological interventions were evaluated. CMA: 148 RCTs (n=9,598) were included in the CMA. Exercise was the only intervention associated with significant improvements for all five outcomes [FIQ (SMD=-0.67; 95% CI -0.89, -0.45), pain (-0.84; 95% CI -1.13, -0.55), fatigue (-0.88; 95% CI -1.39, -0.37), sleep (-0.55; 95% CI -1.04, -0.06) and depression (-0.55; 95% CI -0.82, -0.28)]. Psychological treatments including cognitive behavioural therapy (CBT) and mindfulness were significantly more efficacious than usual care for FIQ, pain and depression but showed no improvement for fatigue and sleep. All exercise types were effective at relieving pain. Mind body and strengthening exercises were effective at improving fatigue, while aerobic and strengthening exercises were effective at improving sleep. All exercise types except for aerobic exercise improved depression. NMA: 78 studies (n = 5,639 participants) met the inclusion criteria. While multidisciplinary treatment (MDT) was the best for improving pain [-1.28 (-1.84, -0.72)], sleep [-1.14 (-2.38, 0.07)] and depression [-1.20 (-1.99, -0.46)], balneotherapy and exercise were the most effective treatments for overall FIQ [-1.06 (-1.52, -0.62)] and fatigue [-0.75 (-1.35, -0.25)] respectively. Data from 47 exercise trials (n = 3,271 participants) were also analysed to examine the relative efficacy of different exercise types. Of the different types of exercise, strengthening showed the greatest benefits for FIQ [-0.76 (-1.39, -0.15)], pain [-0.94 (-1.58, -0.29)] and depression [-0.83 (-1.53, -0.14)], whereas aerobic exercise was the best for fatigue [-0.98 (-2.33, 0.18)] and sleep disorders [-0.96 (-2.08, 0.13)]. Delphi exercise: Of 48 invitees, 17 agreed to participate. These included seven rheumatologists, two physiotherapists, one psychologist, one nurse and six people from other professional backgrounds, specifically physical medicine and rehabilitation, neurology, immunology and public health. Response and completion rates for the 17 participants were 100%. Aerobic exercise, education, sleep hygiene, CBT, mindfulness, mind-body exercise and stress management were recommended for all four outcomes. Also, all these interventions except for mindfulness were voted as core in the management of FM. Conclusions Several non-pharmacological interventions are beneficial for FM. Some interventions appear particularly efficacious for certain FM manifestations. The results of this study should be used to guide the selection of the most beneficial interventions according to the predominant symptom(s) of the individual patient. Further research is required to evaluate if such a strategy better improves outcomes in FM patients. Registration The protocol for the systematic review of non-pharmacological interventions for FM has been registered with the international prospective register of systematic reviews (PROSPERO), registration number CRD42017074982

The effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness: A systematic review [version 1; referees: 2 approved]

Background: Dizziness is a non-specific term used by patients to describe several symptoms ranging from true vertigo, light headedness, disorientation or sense of imbalance. Vestibular rehabilitation (VR) is a specific form of exercise-based therapy programme aimed at alleviating the primary and secondary problems of a vestibular pathology. The aim of this study was to investigate the effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness. Methods: The following five databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE, PubMed, the Physiotherapy Evidence Database (PEDro) and Scopus (Elsevier). Two investigators independently reviewed all articles and a systematic review of literature was performed using the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). The articles were included if they met the following inclusion criteria: (1) randomised controlled trial, (2) people with chronic dizziness, (3) adults aged 18 or over, (4) exercise-based VR, (5) VR exercises compared with sham or usual care, non-treatment or placebo and (6) only studies published full text in English. Results: The initial search identified 304 articles, four of which met the criteria for analysis. All studies involved some form of vestibular rehabilitation, including vestibular compensation, vestibular adaptation and substitution exercises. These exercises were compared with usual medical care (three studies) or placebo eye exercise (one study). The Vertigo Symptom Scale was the most commonly used outcome measure to assess subjective perception of symptoms of dizziness (three studies). According to the PEDro scale, three studies were considered to be of high quality, and one was rated as fair.  Conclusions: This review suggests that exercise-based vestibular rehabilitation shows benefits for adult patients with chronic dizziness with regard to improvement in the vertigo symptom scale, fall risk, balance and emotional status

Efficacy of nonpharmacological interventions for individual features of fibromyalgia:a systematic review and meta-analysis of randomised controlled trials

Fibromyalgia is a highly heterogeneous condition, but the most common symptoms are widespread pain, fatigue, poor sleep, and low mood. Nonpharmacological interventions are recommended as first-line treatment of fibromyalgia. However which interventions are effective for the different symptoms is not well understood. The objective of this study was to assess the efficacy of nonpharmacological interventions on symptoms and disease-specific quality of life. Seven databases were searched from their inception until June 1, 2020. Randomised controlled trials comparing any nonpharmacological intervention to usual care, waiting list, or placebo in people with fibromyalgia aged >16 years were included without language restriction. Fibromyalgia Impact Questionnaire (FIQ) was the primary outcome measure. Standardised mean difference and 95% confidence interval were calculated using random effects model. The risk of bias was evaluated using the modified Cochrane tool. Of the 16,251 studies identified, 167 randomised controlled trials (n = 11,012) assessing 22 nonpharmacological interventions were included. Exercise, psychological treatments, multidisciplinary modality, balneotherapy, and massage improved FIQ. Subgroup analysis of different exercise interventions found that all forms of exercise improved pain (effect size [ES] -0.72 to -0.96) and depression (ES -0.35 to -1.22) except for flexibility exercise. Mind-body and strengthening exercises improved fatigue (ES -0.77 to -1.00), whereas aerobic and strengthening exercises improved sleep (ES -0.74 to -1.33). Psychological treatments including cognitive behavioural therapy and mindfulness improved FIQ, pain, sleep, and depression (ES -0.35 to -0.55) but not fatigue. The findings of this study suggest that nonpharmacological interventions for fibromyalgia should be individualised according to the predominant symptom

Neurological and musculoskeletal features of COVID-19: a systematic review and meta-analysis

Importance: Some of the symptoms of COVID-19 are fever, cough, and breathing difficulty. However, the mechanism of the disease, including some of the symptoms such as the neurological and musculoskeletal symptoms, is still poorly understood. Objective: The aim of this review is to summarize the evidence on the neurological and musculoskeletal symptoms of the disease. This may help with early diagnosis, prevention of disease spread, and treatment planning. Data Sources: MEDLINE, EMBASE, Web of Science, and Google Scholar (first 100 hits) were searched until April 17, 2020. The key search terms used were “coronavirus” and “signs and symptoms.” Only studies written in English were included. Study Selection: The selection was performed by two independent reviewers using EndNote and Rayyan software. Any disagreement was resolved by consensus or by a third reviewer. Data Extraction and Synthesis: PRISMA guidelines were followed for abstracting data and assessing the quality of the studies. These were carried out by two and three independent reviewers, respectively. Any disagreement was resolved by consensus or by a third reviewer. The data were analyzed using qualitative synthesis and pooled using a random-effect model. Main Outcome(s) and Measure(s): The outcomes in the study include country, study design, participant details (sex, age, sample size), and neurological and musculoskeletal features. Result: Sixty studies (n = 11, 069) were included in the review, and 51 studies were used in the meta-analysis. The median or mean age ranged from 24 to 95 years. The prevalence of neurological and musculoskeletal manifestations was 35% for smell impairment (95% CI 0–94%; I 99.63%), 33% for taste impairment (95% CI 0–91%; I 99.58%), 19% for myalgia (95% CI 16–23; I 95%), 12% for headache (95% CI 9–15; I 93.12%), 10% for back pain (95% CI 1–23%; I 80.20%), 10% for dizziness (95% CI 3–19%; I 86.74%), 3% for acute cerebrovascular disease (95% CI 1–5%; I 0%), and 2% for impaired consciousness (95% CI 1–2%; I 0%). Conclusion and Relevance: Patients with COVID-19 present with neurological and musculoskeletal symptoms. Therefore, clinicians need to be vigilant in the diagnosis and treatment of these patients

Efficacy of prolotherapy in comparison to other therapies for chronic soft tissue injuries: A systematic review and network meta-analysis.

IntroductionProlotherapy and other injections, primarily acting on pathways associated with maladaptive tissue repair, are recommended for recalcitrant chronic soft tissue injuries (CSTI). However, selection of injection is challenging due to mixed results. This network meta-analysis (NMA) aimed to compare prolotherapy with other therapies, particularly injections, for CSTI and establish robustness of the results.MethodologyPubmed, Medline, SPORTDiscus and Google scholar were searched from inception to 4th January 2021 for randomised controlled trials (RCTs) involving injection therapies (e.g. blood derivatives, corticosteroid, hyaluronic acid, botulinum toxin) for CSTI. The primary and secondary outcomes were pain and function, respectively, at (or nearest to) 6 months. Effect size (ES) was presented as standardised mean difference with 95% confidence interval (CI). Frequentist random effect NMA was used to generate the overall estimates, subgroup estimates (by region and measurement time point) and sensitivity analyses.ResultsA total of 91 articles (87 RCTs; 5859 participants) involving upper limb (74%), lower limb (23%) and truncal/hip (3%) injuries were included. At all time points, prolotherapy had no statistically significant pain benefits over other therapies. This observation remained unchanged when tested under various assumptions and with exclusion of studies with high risk of bias. Although prolotherapy did not offer statistically significant functional improvement compared to most therapies, its ES was consistently better than non-injections and corticosteroid injection for both outcomes. At selected time points and for selected injuries, prolotherapy demonstrated potentially better pain improvement over placebo (8 months: shoulder [ES 2.08; 95% CI 1.49, to 2.68]). Injections generally produced greater ES when combined with non-injection therapy.ConclusionWhile clinical outcomes were generally comparable across types of injection therapy, prolotherapy may be used preferentially for selected conditions at selected times