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[Guidelines for the diagnosis and treatment of the fibromyalgia syndrome]
Abstract
Over the past years, considerable progress has been made in understanding the pathogenesis of the fibromyatgia syndrome and the evidence based approach to the diagnosis and management has been significantty extended. The purpose of the current project is to develop practicat and evidence based guidetine recommendations for the Israeli health care system. A panet of physicians with clinical and research experience in the fibromyalgia field was convened under the auspices of the Israeli Rheumatology Association. A systematic review was performed on the current literature regarding the diagnosis and treatment of fibromyalgia. Using an interactive discussion procedure, recommendations were reached and expert opinion was introduced where evidence was considered incomplete. The panel recommendations underline the importance of concomitant and integrated medical therapy, such as serotonin and noradrenaline reuptake inhibitor (SNRI) anti-depressants or gamma-aminobutyric acid (GABA) related anti-epileptics, with regular aerobic physical exercise.
... Although nonpharmacologic therapies have been shown to significantly improve FM symptoms, they are less preferred by patients than drug alternatives. 13,14 Several guidelines have been published to guide pharmacological treatment of FM. [15][16][17][18][19] Additionally, while opioid use for FM-associated pain control is seen in clinical practice, the use of chronic opioid therapy is not recommended due to the clinical and societal consequences, 20 with the most recent guidelines discouraging use of strong opioids. [17][18][19] Only three drugs have been approved by the Food and Drug Administration (FDA) for treatment of FM: pregabalin (2007), duloxetine (2008), and milnacipran (2009). ...
... 13,14 Several guidelines have been published to guide pharmacological treatment of FM. [15][16][17][18][19] Additionally, while opioid use for FM-associated pain control is seen in clinical practice, the use of chronic opioid therapy is not recommended due to the clinical and societal consequences, 20 with the most recent guidelines discouraging use of strong opioids. [17][18][19] Only three drugs have been approved by the Food and Drug Administration (FDA) for treatment of FM: pregabalin (2007), duloxetine (2008), and milnacipran (2009). All three agents have received a strong recommendation for use in FM from the more recent pharmacological treatment guidelines [16][17][18][19] and a modest evidence for efficacy rating from the older American Pain Society 2005 guideline. ...
... [17][18][19] Only three drugs have been approved by the Food and Drug Administration (FDA) for treatment of FM: pregabalin (2007), duloxetine (2008), and milnacipran (2009). All three agents have received a strong recommendation for use in FM from the more recent pharmacological treatment guidelines [16][17][18][19] and a modest evidence for efficacy rating from the older American Pain Society 2005 guideline. 15 No head-to-head comparative trials of the three FDA-approved FM treatments have been conducted. ...
Purpose
To examine the impact of newly initiated pregabalin or duloxetine treatment on fibromyalgia (FM) patients’ encounters with potential drug–drug interactions (DDIs), the health care cost and utilization consequences of those interactions, and the impact of treatment on opioid utilization.
Patients and methods
Subjects included those with an FM diagnosis, a pregabalin or duloxetine prescription claim (index event), ≥1 inpatient or ≥2 outpatient medical claims, and ≥12 months preindex and ≥6 postindex enrollment. Propensity score matching was used to help balance the pregabalin and duloxetine cohorts on baseline demographics and comorbidities. Potential DDIs were defined based on Micromedex 2.0 software and were identified by prescription claims.
Results
No significant differences in baseline characteristics were found between matched pregabalin (n=794) and duloxetine cohorts (n=794). Potential DDI prevalence was significantly greater (P<0.0001) among duloxetine subjects (71.9%) than among pregabalin subjects (4.0%). There were no significant differences in all-cause health care utilization or costs between pregabalin subjects with and without a potential DDI. By contrast, duloxetine subjects with a potential DDI had higher mean all-cause costs ($9,373 versus $7,228; P<0.0001) and higher mean number of outpatient visits/member (16.0 versus 13.0; P=0.0009) in comparison to duloxetine subjects without a potential DDI. There was a trend toward a statistically significant difference between pregabalin and duloxetine subjects in their respective pre- versus post-differences in use of ≥1 long-acting opioids (1.6% and 3.4%, respectively; P=0.077).
Conclusion
The significantly higher prevalence of potential DDIs and potential cost impact found in FM duloxetine subjects, relative to pregabalin subjects, underscore the importance of considering DDIs when selecting a treatment.
... FMS opinion leaders reported two guidelines. Three of these met our inclusion criteria: the 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome [10], the guidelines of the Association of the Scientific Medical Societies in Germany (AWMF) on the definition, pathophysiology, diagnosis, and treatment of fibromyalgia syndrome [11][12][13][14][15][16][17][18][19], and the Israeli guidelines for the diagnosis and treatment of fibromyalgia syndrome [20]. The reasons for excluding other hits were as follows: duplications ( = 19), not commissioned by a scientific society ( = 2) [21,22]. ...
... The Israeli guidelines were developed by the Israeli fibromyalgia group, on behalf of the Israeli Rheumatology Association. This group was formed within the national rheumatology association and included a group of experts with both clinical and research interest in FMS [20]. ...
... All three countries justified the need for development of guidelines on the basis of the high prevalence of FMS and the association of reduced healthrelated quality of life of patients and high healthcare costs as well as controversies surrounding diagnosis and management [10,11,20]. The prevalence rates of FMS-assessed by different methodologies-were comparable between the three countries: Canada 2-3% [25], Germany 2.1% [5], and Israel 2.6% [3]. ...
Objectives. Fibromyalgia syndrome (FMS), characterized by subjective complaints without physical or biomarker abnormality, courts controversy. Recommendations in recent guidelines addressing classification and diagnosis were examined for consistencies or differences. Methods. Systematic searches from January 2008 to February 2013 of the US-American National Guideline Clearing House, the Scottish Intercollegiate Guidelines Network, Guidelines International Network, and Medline for evidence-based guidelines for the management of FMS were conducted. Results. Three evidence-based interdisciplinary guidelines, independently developed in Canada, Germany, and Israel, recommended that FMS can be clinically diagnosed by a typical cluster of symptoms following a defined evaluation including history, physical examination, and selected laboratory tests, to exclude another somatic disease. Specialist referral is only recommended when some other physical or mental illness is reasonably suspected. The diagnosis can be based on the (modified) preliminary American College of Rheumatology (ACR) 2010 diagnostic criteria. Discussion. Guidelines from three continents showed remarkable consistency regarding the clinical concept of FMS, acknowledging that FMS is neither a distinct rheumatic nor mental disorder, but rather a cluster of symptoms, not explained by another somatic disease. While FMS remains an integral part of rheumatology, it is not an exclusive rheumatic condition and spans a broad range of medical disciplines.
... FMS opinion leaders reported two guidelines. Three of these met our inclusion criteria: the 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome [9], the guideline of the Association of the Scientific Medical Societies in Germany on the definition, pathophysiology, diagnosis, and treatment of fibromyalgia syndrome (AWMF) [10][11][12][13][14][15], and the Israeli guidelines for the diagnosis and treatment of the fibromyalgia syndrome [16]. The reasons for excluding other hits were as follows: duplications ( = 19); no criteria for establishing level of evidence outlined ( = 1); not commissioned by a scientific society ( = 1). ...
... symptoms and treatment options [9,10,16]. The Canadian and German guideline recommended that healthcare professionals should be empathetic, open, and honest and should not demonstrate negative attitudes. ...
... All three guidelines recommended that attention should be paid to individual symptoms (e.g., pain, sleep problems, fatigue, and depression) in a patient tailored approach [9,10,16]. The German guideline emphasized consideration of patient comorbidities as well as patient preference in the selection of therapeutic measures [10]. ...
Objective. Current evidence indicates that there is no single ideal treatment for fibromyalgia syndrome (FMS). First choice treatment options remain debatable, especially concerning the importance of complementary and alternative medicine (CAM) treatments. Methods. Three evidence-based interdisciplinary guidelines on FMS in Canada, Germany, and Israel were compared for their first choice and CAM-recommendations. Results. All three guidelines emphasized a patient-tailored approach according to the key symptoms. Aerobic exercise, cognitive behavioral therapy, and multicomponent therapy were first choice treatments. The guidelines differed in the grade of recommendation for drug treatment. Anticonvulsants (gabapentin, pregabalin) and serotonin noradrenaline reuptake inhibitors (duloxetine, milnacipran) were strongly recommended by the Canadian and the Israeli guidelines. These drugs received only a weak recommendation by the German guideline. In consideration of CAM-treatments, acupuncture, hypnosis/guided imagery, and Tai Chi were recommended by the German and Israeli guidelines. The Canadian guidelines did not recommend any CAM therapy. Discussion. Recent evidence-based interdisciplinary guidelines concur on the importance of treatment tailored to the individual patient and further emphasize the need of self-management strategies (exercise, and psychological techniques).
... FM is a complex multi-system syndrome difficult to assess in terms of severity due to the lack of disease biomarkers and gold standard outcome measures [3]. Recent evidence-based guidelines for the management of FM recommended a graduated, severity-based approach to treatment, which is important when evaluating alternative treatments, the use of medical resources, costs and quality of life adjustments [14,24,25]. The definition of disease severity categories for FM can primarily serve to establish realistic goals that can be achieved in the individual patient by tailoring the treatment strategy. ...
... In the case of patients with severe FM, it seems to be logical to intensify treatment using non-pharmacological therapeutic approaches such as physical exercise and psychological interventions. The clinical criteria defining severity are based on somatic and psychological distress levels, disability and the use of healthcare resources [24,25,27]; however, the lack of internationally accepted indices of grading severity can be considered a major obstacle. ...
Objective:
To establish optimal cut-off values for the scores of the revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromialgia Assessment Scale (FAS 2019mod), and the Polysymptomatic Distress Scale (PDS) in order to distinguish five levels of FM disease severity.
Methods:
Consecutive FM patients were evaluated with the three clinimetric indices, and each patient was required to answer the anchor question: 'In general, would you say your health is 1 = very good, 2 = good, 3 = fair, 4 = poor, or 5 = very poor?'-which represented the external criterion. Cut-off points were established through the interquartile reconciliation approach.
Results:
The study sample consisted of 2181 women (93.2%) and 158 men (6.8%), with a mean age of 51.9 (11.5) years, and mean disease duration was 7.3 (6.9) years. The overall median FIQR, FAS 2019 mod and PDS scores (25th-75th percentiles) were respectively 61.16 (41.16-77.00), 27.00 (19.00-32.00) and 19.0 (13.00-24.00). Reconciliation of the mean 75th and 25th percentiles of adjacent categories defined the severity states for FIQR: 0-23 for remission, 24-40 for mild disease, 41-63 for moderate disease, 64-82 for severe disease and >83 for very severe disease; FAS 2019 mod: 0-12 for remission, 13-20 for mild disease, 21-28 for moderate disease, 29-33 for severe disease and >33 for very severe disease; PDS: 0-5 for remission, 6-15 for mild disease, 16-20 for moderate disease, 21-25 for severe disease and >25 for very severe disease.
Conclusions:
Disease severity cut-offs can represent an important improvement in interpreting FM.
... Therefore, in line with all current guidelines for FM care, patients must be evaluated with a comprehensive medical history and examination to identify any features that could perhaps point to an alternate diagnosis. 2,27,35,56 Diagnoses that can be confused with FM may be broadly grouped into the following categories: inflammatory rheumatic diseases, nonrheumatic musculoskeletal conditions, nonrheumatic medical conditions (endocrinology, gastroenterology, infectious diseases, and oncology), neurological conditions, mental health disorders, and medication-induced pain conditions. 43 In this report, we will describe various diagnoses that should be considered when a patient presents with a complaint of CWP and will highlight clinical features to assist the health care professional in establishing a correct diagnosis. ...
... The foundation for evaluating a patient with CWP is a comprehensive history and physical examination, which may be followed by specifically directed investigations as indicated (Table 1). 2,27,35,56 Although some tools have been developed to help primary care physicians' screen for FM, they are only a screen and should not be used to establish a diagnosis. 11,68 As a first step, the location of pain can be assessed by means of a pain diagram and if pain is observed to be diffuse (according to the 2016 criteria), further questioning regarding associated symptoms of unrefreshed sleep and fatigue should be pursued. ...
Introduction
Chronic widespread pain (CWP) is the defining feature of fibromyalgia (FM), a worldwide prevalent condition. Chronic widespread pain is, however, not pathognomonic of FM, and other conditions may present similarly with CWP, requiring consideration of a differential diagnosis.
Objectives
To conduct a literature search to identify medical conditions that may mimic FM and have highlighted features that may differentiate these various conditions from FM.
Methods
A comprehensive literature search from 1990 through September 2016 was conducted to identify conditions characterized by CWP.
Results
Conditions that may mimic FM may be categorized as musculoskeletal, neurological, endocrine/metabolic, psychiatric/psychological, and medication related. Characteristics pertaining to the most commonly identified confounding diagnoses within each category are discussed; clues to enable clinical differentiation from FM are presented; and steps towards a diagnostic algorithm for mimicking conditions are presented.
Conclusion
Although the most likely reason for a complaint of CWP is FM, this pain complaint can be a harbinger of illness other than FM, prompting consideration of a differential diagnosis. This review should sensitize physicians to a broad spectrum of conditions that can mimic FM.
... Despite these limitations, German and Israeli guidelines recommend temporary use of BT and HT (grade B/C) [13,14]. Furthermore, BT and HT are often part of MCT (at least one exercise and one psychological component) but they are not analyzed separately. ...
... Furthermore, BT and HT are often part of MCT (at least one exercise and one psychological component) but they are not analyzed separately. In several evidencedbased guidelines and reviews, MCT and aerobic exercises (land-based or water-based) are strongly recommended [12][13][14][15]. The aim of the present review is to offer an update of the literature on BT and HT in FMS, with special focus on separate analyses of the different treatment modalities. ...
Introduction:
In the present systematic review and meta-analysis, we assessed the effectiveness of different forms of balneotherapy (BT) and hydrotherapy (HT) in the management of fibromyalgia syndrome (FMS).
Methods:
A systematic literature search was conducted through April 2013 (Medline via Pubmed, Cochrane Central Register of Controlled Trials, EMBASE, and CAMBASE). Standardized mean differences (SMDs) and 95% confidence intervals (CIs) were calculated using a random-effects model.
Results:
Meta-analysis showed moderate-to-strong evidence for a small reduction in pain (SMD -0.42; 95% CI [-0.61, -0.24]; P < 0.00001; I2 = 0%) with regard to HT (8 studies, 462 participants; 3 low-risk studies, 223 participants), and moderate-to-strong evidence for a small improvement in health-related quality of life (HRQOL; 7 studies, 398 participants; 3 low-risk studies, 223 participants) at the end of treatment (SMD -0.40; 95% CI [-0.62, -0.18]; P = 0.0004; I2 = 15%). No effect was seen at the end of treatment for depressive symptoms and tender point count (TPC).
Conclusions:
High-quality studies with larger sample sizes are needed to confirm the therapeutic benefit of BT and HT, with focus on long-term results and maintenance of the beneficial effects.
... The principles of general management and initial treatment guidelines for FMS from Israel (2012) [81], Canada (2012) [82], Germany (2012) [83], and the European Alliance of Associations for Rheumatology (EULAR) (2016) [84] advocate for activities like aerobic and strengthening exercises. While techniques such as meditative movement therapies, mindfulness-based stress reduction, acupuncture, and hydrotherapy receive less robust recommendations, treatments like hypnosis, massage, and complementary and alternative therapies have not been endorsed [85]. ...
Fibromyalgia and osteoarthritis are among the most prevalent rheumatic conditions worldwide. Nonpharmacological interventions have gained scientific endorsements as the preferred initial treatments before resorting to pharmacological modalities. Repetitive transcranial magnetic stimulation (rTMS) is among the most widely researched neuromodulation techniques, though it has not yet been officially recommended for fibromyalgia. This review aims to summarize the current evidence supporting rTMS for treating various fibromyalgia symptoms. Recent findings: High-frequency rTMS directed at the primary motor cortex (M1) has the strongest support in the literature for reducing pain intensity, with new research examining its long-term effectiveness. Nonetheless, some individuals may not respond to M1-targeted rTMS, and symptoms beyond pain can be prominent. Ongoing research aims to improve the efficacy of rTMS by exploring new brain targets, using innovative stimulation parameters, incorporating neuronavigation, and better identifying patients likely to benefit from this treatment. Summary: Noninvasive brain stimulation with rTMS over M1 is a well-tolerated treatment that can improve chronic pain and overall quality of life in fibromyalgia patients. However, the data are highly heterogeneous, with a limited level of evidence, posing a significant challenge to the inclusion of rTMS in official treatment guidelines. Research is ongoing to enhance its effectiveness, with future perspectives exploring its impact by targeting additional areas of the brain such as the medial prefrontal cortex, anterior cingulate cortex, and inferior parietal lobe, as well as selecting the right patients who could benefit from this treatment.
... Of note, GAD was the most common type of ADs in these studies. Another survey had further revealed that a woman with FM was five times more likely to experience one type of ADs during her lifetime in comparison to a healthy individual (Ablin et al., 2013), which is consistent with the results of this study and some other previous reports (Hosseini et al., 2015;Kayhan et al., 2016;Uguz et al., 2010). ...
Aim:
This study aimed to investigate psychiatric disorders in Iranian female patients with fibromyalgia (FM).
Design:
Female patients, newly diagnosed with FM, were interviewed by a psychiatrist for psychiatric assessments during a 2-year period.
Methods:
The diagnosis of the psychiatric disorders was based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI).
Results:
In total, 159 patients with the mean age of 42.15 ± 9.89 were recruited in this study. Over 92% of the cases were also diagnosed with at least one type of psychiatric disorder. Sleep disorders (SDs, 90.57%), mood disorders (MDs, 52.83%), personality disorders (PDs, 40.25%) and anxiety disorders (ADs, 16.98%) were the most prevalent diagnoses among these patients. The logistic regression results correspondingly showed that suffering from Cluster-B PDs was associated with a higher prevalence rate of somatic symptom disorders (SSDs), with a p-value of 0.019 and an odds ratio (OR) of 2.7.
... Patients in the medication group were assigned to receive pharmacological intervention for three-month period, with one of the two medications currently approved in Israel for FMS, Duloxetine and Pregabalin, as outlined in the local rheumatology guidelines for the diagnosis and treatment of FMS [27]. Drugs were chosen by the treating rheumatologist, following a detailed explanation to the patient. ...
Fibromyalgia is a chronic pain syndrome with unsatisfactory response to current treatments. Physical trauma, including traumatic brain Injury (TBI) is among the etiological triggers. Hyperbaric Oxygen therapy (HBOT) is an intervention that combines 100% oxygen with elevated atmospheric pressure. HBOT has been applied as a neuro-modulatory treatment in central nervous system-related conditions. The current study investigated the utility of HBOT for TBI-related fibromyalgia. Fibromyalgia patients with a history of TBI were randomized to either HBOT or pharmacological intervention. HBOT protocol comprised 60 daily sessions, breathing 100% oxygen by mask at 2 absolute atmospheres (ATA) for 90 minutes. Pharmacological treatment included Pregabalin or Duloxetine. The primary outcome was subjective pain intensity on visual analogue scale (VAS); Secondary endpoints included questionnaires assessing fibromyalgia symptoms as well as Tc-99m-ECD SPECT brain imaging. Pain threshold and conditioned pain modulation (CPM) were also assessed. Results demonstrated a significant group-by-time interaction in pain intensity post-HBOT compared to the medication group (p = 0.001), with a large net effect size (d = -0.95) in pain intensity reduction following HBOT compared to medications. Fibromyalgia related symptoms and pain questionnaires demonstrated significant improvements induced by HBOT as well as improvements in quality of life and increase in pain thresholds and CPM. SPECT demonstrated significant group-by-time interactions between HBOT and medication groups in the left frontal and the right temporal cortex. In conclusion, HBOT can improve pain symptoms, quality of life, emotional and social function of patients suffering from FMS triggered by TBI. The beneficial clinical effect is correlated with increased brain activity in frontal and parietal regions, associated with executive function and emotional processing.
... Opioids or dopaminergic agents had no e ect on pain and carry the risk of drug dependency [5]. In the German S3 guideline of 2017 [8] and the European Alliance of Associations for Rheumatology (EULAR) recommendations of 2016 [9], amitriptyline, duloxetine, and pregabalin are recommended as temporary drug therapies for FMS. e Canadian and Israeli guidelines advise to use SNRIs and anticonvulsants (pregabalin and gabapentin) [10,11]. All guidelines also point out that nonpharmacological therapy such as aerobic training or cognitive-based behavioral therapy may be more e cient in the relief of pain and fatigue, with fewer side e ects. ...
There is no approved drug for Fibromyalgia syndrome (FMS) in Europe. In the German S3 guideline, amitriptyline, duloxetine, and pregabalin are recommended for temporary use. The aim of this study was to cross-sectionally investigate the current practice of medication in FMS patients in Germany. We systematically interviewed 156 patients with FMS, while they were participating in a larger study. The patients had been stratified into subgroups with and without a decrease in intraepidermal nerve ber density. The drugs most commonly used to treat FMS pain were nonsteroidal anti-inflammatory drugs (NSAIDs) (41.0% of all patients), metamizole (22.4%), and amitriptyline (12.8%). The most frequent analgesic treatment regimen was "on demand" (53.9%), during pain attacks, while 35.1% of the drugs were administered daily and the remaining in other regimens. Median pain relief as self-rated by the patients on a numerical rating scale (0-10) was 2 points for NSAIDS, 2 for metamizole, and 1 for amitriptyline. Drugs that were discontinued due to lack of efficacy rather than side effects were acetaminophen, upirtine, and selective serotonin reuptake inhibitors. Reduction in pain severity was best achieved by NSAIDs and metamizole. Our hypothesis that a decrease in intraepidermal nerve ber density might represent a neuropathic subtype of FMS, which would be associated with better effectiveness of drugs targeting neuropathic pain, could not be confirmed in this cohort. Many FMS patients take "on-demand" medication that is not in line with current guidelines. More randomized clinical trials are needed to assess drug effects in FMS subgroups.
... Several guidelines and review articles pertaining to the treatment of FMS have been published by official academic associations, including the European League Against Rheumatism (EULAR), 3 Israeli Rheumatology Association, 17,68 Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (Germany), 69,70 and Canadian National Fibromyalgia Guideline Advisory Panel. 2 Each guideline has been developed to suit the medical system of its respective country or region, so it is difficult to apply any of them directly to clinical medicine in South Korea. However, because the guidelines mainly describe evidence-based medicine and were written by leading researchers in a multidisciplinary way, they are still useful. ...
Fibromyalgia syndrome (FMS) has chronic widespread pain (CWP) as a core symptom and a variety of associated somatic and psychological symptoms such as fatigue, sleep problems, cognitive disturbances, multiple somatic pain, and depression. FMS is the subject of considerable controversy in the realm of nosology, diagnosis, pathophysiology, and treatment.Moreover, the fact that FMS and mental illness are closely associated with each other might intensify the confusion for the distinction between FMS and mental disorders. This narrative literature review aims to provide the concept, diagnosis, and treatment of FMS from the integrative biopsychosocial and psychosomatic perspective. This article first explains the concepts of FMS as a disease entity of biopsychosocial model, and then summarizes the changes of diagnostic criteria over past three decades, differential diagnosis and comorbidity issue focused on mental illnesses. In addition, an overview of treatment of FMS is presented mainly by arranging the recommendations from the international guidelines which have been developed by four official academic associations.
... For FM, there are no precise recommendations. Endurance training is recommended by different medical societies for FM management (8,(11)(12)(13)(14) in the range of two to three sessions a week, allowing to respect a rest period and avoid exacerbation of symptoms, at least for a period of 4-6 weeks in order to see a decrease in symptoms (15,16) and a change in autonomic function (17). A light-intensity aerobic practice (15,18) does not allow a decrease in symptom intensity, rather indicating a moderate to vigorous intensity physical activity (MVPA) practice. ...
Introduction: Fibromyalgia (FM) is characterized by multiple symptoms including pain, fatigue, and sleep disorders, altering patient's quality of life. In the absence of effective pharmacological therapy, the last European guidelines recommend a multidisciplinary management based on exercise and education. Thus, our main objective was to measure the effectiveness of a healthcare organization offering a specific program of adapted physical activity combined with a therapeutic education program for FM patients.
Methods and Analysis: The From Intent To Move (FIMOUV) study will recruit 330 FM patients randomized into two groups: test and control. The test group will benefit from a 1-month mixed exercise training program supervised at the hospital, followed by 2 months in a community-based relay in a health-sport structure. In addition, each of the two groups will benefit from therapeutic patient education sessions. The main endpoint is the measurement of the level of physical activity by accelerometry at 1 year. The secondary endpoints concern adherence to the practice of physical activity, impact on lifestyle, state of health, and physical capacity, as well as an estimate of the budgetary impact of this management strategy.
Discussion: This interventional research will allow us to assess the evolution of behaviors in physical activity after an FM syndrome management based solely on patient education or based on a supervised and adapted practice of physical activity associated with this same therapeutic education program. It seems to be the first study evaluating the impact of its intervention on objective data for measuring physical activity and sedentary behavior via accelerometry among FM patients.
Trial registration: ClinicalTrials.gov NCT04107948.
... A multidisciplinary approach to FM: the importance of psychoeducation It is now widely acknowledged that a multidimensional diagnostic approach encompassing somatic complaints, psychological factors, psychosocial stressors and subjective beliefs is more appropriate (10,19). The above issues were considered and integrated in the three evidence-based multidisciplinary guidelines for the diagnosis and management of FM (20,21). All three guidelines also emphasise the importance of psychiatric comorbidity. ...
Although the mechanisms underlying fibromyalgia are not yet clear, many attempts have been made to implement pharmacological therapy and help patients manage its psychological and physical symptoms. Recent evidence has shown that an interdisciplinary multidimensional approach encompassing psychological factors, emotion regulation strategies and education on illness is more effective in improving quality of life, both in the short- and long-term, than usual treatments alone. The purpose of this review is to provide an updated overview of the available literature regarding the role of psychoeducation on fibromyalgia symptoms and health outcomes. We searched on PubMed Database with the keywords "fibromyalgia", "education" and "psychology" and then divided the results of our research into four main categories: effectiveness of psychoeducational programs versus treatment as usual, psychoeducational interventions versus other non-pharmacological treatments, Online-based education programs and specific characteristics of the participants. Our research highlighted that most of the considered studies found significant positive results on patients' condition, suggesting that an interdisciplinary intervention containing psychoeducation is an effective strategy in managing fibromyalgia symptoms.
... To the best of our knowledge, this is the first attempt to realise such kind of categorisation for the two indexes. The recent guidelines for functional somatic syndromes (including FM) suggested a treatment strategy according to severity of disease (27)(28)(29). However, up to now, the lack of international accepted instruments to categorise severity of FM represented a major gap. ...
Objectives:
To establish the cut-off points for disease severity states of two self-administered questionnaires (the revised version of the Fibromyalgia-Impact Questionnaire [FIQR] and the Fibromyalgia Assessment Status [FAS]) designed for the evaluation of multidimensional aspects of fibromyalgia (FM).
Methods:
In this cross-sectional study, consecutive FM patients completed both FIQR and FAS. The external criterion for grading disease severity was the item one of the Short Form-36 Health Survey (SF-36). The reconciliation approach of the 75th-25th percentiles of adjacent ranks was applied to establish cut-off points distinguishing between disease activity states.
Results:
521 FM patients (80.0% women, mean age 49 years) completed the assessment. The overall mean (standard deviation [SD]) FIQR and FAS were 47.87 (SD 20.69) and 5.57 (SD 2.09), respectively. The highest FIQR scored items were those related to sleep quality, fatigue/energy, pain, stiffness, tenderness, and environmental sensitivity. With the reconciliation of 75th-25th percentiles of adjacent ranks, the FIQR cut-off points obtained were: remission ≤30, mild severity >30 and ≤45, moderate severity >46 and ≤65, high severity >65. The same approach for FAS leaded to: remission ≤4, mild severity >4 and ≤5.5, moderate severity >5.6 and ≤7.0, high severity >7.0. The majority of the subjects was classified as suffering from a moderate (FIQR 28.4%; FAS 23.2%) or severe (FIQR 24.4%; FAS 30.7%) FM.
Conclusions:
The FIQR and FAS cut-off points for remission, mild, moderate and high disease severity are valid measures which can be easily applied in daily clinical practice.
... Multimodal treatments were recommended in people with severe disability. There are inconsistencies between the EULAR guidelines and previous guidelines from Germany [23], Canada [24] and Israel [25]. The Canadian and Israeli guidelines strongly recommended serotonin noradrenaline reuptake inhibitors (SNRIs) and anticonvulsants, although these were weakly recommended in EULAR guidelines. ...
Background and aims
Fibromyalgia is a complex condition characterised by widespread pain, sleep disturbance, fatigue and cognitive impairment, with a global mean prevalence estimated at 2.7%. There are inconsistencies in guidelines on the treatment of fibromyalgia leading to dissatisfaction from patients and healthcare professionals. This study investigated patient-reported outcomes of pharmacological and non-pharmacological treatment usage and effectiveness with an assessment of acceptability.
Methods
Nine hundred and forty-one participants completed a self-administered anonymous questionnaire giving quantitative data of demographics, treatment usage and treatment outcomes. Participant-reported effectiveness and side effects were compared in the following treatment classes: analgesics, antidepressants, gabapentinoids, gastrointestinal treatments, activity interventions, dietary-based treatments, and psychological, physical and alternative therapies. Participants also reported whether they knew about or had tried different treatments.
Results
The results from the online survey indicated that the range of mean effectiveness ratings were similar for pharmacological and non-pharmacological treatments, whereas non-pharmacological treatments had lower side effects ratings and higher acceptability relative to pharmacological treatments. Participants were not aware of some treatment options.
Conclusions
The results show lower side effects ratings and higher acceptability for non-pharmacological treatments compared to pharmacological treatments despite similar effectiveness ratings.
Implications
This article presents results from a large online survey on fibromyalgia patient perspectives of pharmacological and non-pharmacological treatments. Results will inform healthcare professionals and patients about optimal treatments based on ratings of effectiveness, side effects and acceptability that are tailored to patient symptom profiles. Some participants were unaware of treatment options highlighting the importance of patient education allowing collaboration between patients and healthcare professionals to find optimal treatments.
... Four clinical practice guidelines have been produced to address the screening, diagnosis, management, and monitoring of FMS. 3,[35][36][37] The European League Against Rheumatism clinical practice guidelines (2017) recommends CBT as a nonpharmacological therapy for individuals with poor coping skills, and mood disorders. 3 There is no universal definition of CBT. 17 For this reason, traditional CBT, mindfulness, operant therapy, and self-management education have been considered cognitive-behavioral therapies in FMS studies. ...
Fibromyalgia syndrome is a chronic pain condition that affects 440,000 Canadians above the age of 12. People with fibromyalgia report lifelong biological, emotional, cognitive and social complications. Recent clinical practice guidelines indicate management of symptoms is limited outside of analgesics. Cognitive-behavioral therapy (CBT) is one emerging treatment that displays promise for these individuals. CBT helps individuals to realize their maladaptive thought processes and how these can affect their own emotional response as well as the significance they attribute to potentially noxious stimuli. In conjunction with a physical exercise program, CBT shows promise in both the management of pain, and an improvement of quality of life.
... Four clinical practice guidelines have been produced to address the screening, diagnosis, management, and monitoring of FMS. 3,[35][36][37] The European League Against Rheumatism clinical practice guidelines (2017) recommends CBT as a nonpharmacological therapy for individuals with poor coping skills, and mood disorders. 3 There is no universal definition of CBT. 17 For this reason, traditional CBT, mindfulness, operant therapy, and self-management education have been considered cognitive-behavioral therapies in FMS studies. ...
Fibromyalgia syndrome is a chronic pain condition that
affects 440,000 Canadians above the age of 12. People with
fibromyalgia report lifelong biological, emotional, cognitive
and social complications. Recent clinical practice guidelines
indicate management of symptoms is limited outside of
analgesics. Cognitive-behavioral therapy (CBT) is one emerging
treatment that displays promise for these individuals. CBT
helps individuals to realize their maladaptive thought processes
and how these can affect their own emotional response as well
as the significance they attribute to potentially noxious stimuli.
In conjunction with a physical exercise program, CBT shows
promise in both the management of pain, and an improvement
of quality of life.
... In contrast, the Canadian guideline recommended to consider a trial of a prescribed pharmacological cannabinoid in patients with fibromyalgia, particularly in the setting of significant sleep disturbance (Fitzcharles et al., 2013). The Israeli guideline mentioned cannabis under 'Investigational treatments' and stated that at the current time the evidence supporting the efficacy and safety of cannabis treatment in fibromyalgia are not sufficient, and additional research is necessary regarding this topic (Ablin et al., 2013). ...
Medicinal cannabis has already entered mainstream medicine in some countries. This systematic review (SR) aimed at evaluating the efficacy, acceptability and safety of cannabis-based medicines for chronic pain management. Qualitative systematic review of SRs of randomized controlled trials with cannabis-based medicines for chronic pain management. The Cochrane databases of SRs, Database of Abstracts of Reviews of Effects and PubMed were searched for SR published in the period January 2009 to January 2017. Assessment of the methodological quality of SR was performed by the AMSTAR checklist. Out of 748 papers identified, 10 SRs met the inclusion criteria. The methodological quality was high in four and moderate in six SRs. There were inconsistent findings of four SRs on the efficacy of cannabis-based medicines in neuropathic pain and of one SR for painful spasms in multiple sclerosis. There were consistent results that there was insufficient evidence of any cannabis-based medicine for pain management in patients with rheumatic diseases (three SRs) and in cancer pain (two SRs). Cannabis-based medicines undoubtedly enrich the possibilities of drug treatment of chronic pain conditions. It remains the responsibility of the health care community to continue to pursue rigorous study of cannabis-based medicines to provide evidence that meets the standard of 21st century clinical care.
Significance:
We provide an overview of systematic reviews on the efficacy, tolerability and safety of cannabis-based medicines for chronic pain management. There are inconsistent findings of the efficacy of cannabinoids in neuropathic pain and painful spasms in multiple sclerosis. There are inconsistent results on tolerability and safety of cannabis-based medicines for any chronic pain.
... In this age where increasing numbers of patients are technologically savvy, the use of social media as an educational or treatment tool must be further examined. These questions speak to the need for active patient participation in health practices as has been strongly recommended by recent guidelines for the management of FM[16][17][18][19]. Whether persons with FM should ideally be managed by primary care physicians, specialists or multidisciplinary teams is not known. ...
Background:Research objectives should be focused towards advancing knowledge that has meaningful impact on health. However, research agendas are mostly driven by the health care community, with limited input from patients.
Aims:In this study, prioirities of uncertainties for the management of fibromyalgia (FM), that could propel future research, were identified by a defined process using the James Lind Alliance Priority Setting Partnership (JLA-PSP) methodology.
Methods: As a first step, a survey was distributed across Canada that engaged patients, caregivers and healthcare professionals to provide narrative input to 8 open-ended questions regarding FM care. Responses were thematically condensed and synthesized into an initial list of 43 uncertainties used to guide a comprehensive literature search. Questions already effectively addressed in the literature were excluded, leaving 25 uncertainties that were ranked during a one day consensus workshop.
Results: Three broad themes emerged: the value of personalized targeted treatment and subgrouping of patients; the efficacy of various self-management strategies and educational initiatives; and identification of the ideal health care setting to provide FM care. Opioids and cannabinoids were the only specific pharmacologic interventions ranked as needing further research.
Conclusions: The prioritized questions highlight the importance of recognizing the heterogeneity of FM symptoms, the need for a personalized treatment approach, and a better understanding of the value of self-management strategies. This is the first study that uses an established and transparent methodology to engage all FM stakeholders to help inform researchers and funding bodies of clinically relevant research priorities.
... 0 Treffer. Zwei interdisziplinäre evidenzbasierte Leitlinien aus Kanada [10] und Israel wurden gefunden [1]. Die Evidenzbasierung und Strukturiertheit des Konsensusprozesses dieser beiden Leitlinien waren sehr unterschiedlich. ...
Background:
The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was planned for April 2017.
Methods:
The guidelines were developed by 13 scientific societies and 2 patient self-help organizations coordinated by the German Pain Society. Working groups (n = 8) with a total of 42 members were formed balanced with respect to gender, medical expertise, position in the medical or scientific hierarchy and potential conflicts of interest.
Results:
A systematic search of the literature from December 2010 to May 2016 was performed in the Cochrane library, MEDLINE, PsycINFO and Scopus databases. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine version 2009. The strength of recommendations was achieved by multiple step formalized procedures to reach a consensus. Efficacy, risks, patient preferences and applicability of therapies available were weighed up against each other. The guidelines were reviewed and approved by the board of directors of the societies engaged in the development of the guidelines.
Conclusion:
The guidelines are published in several forms, i.e. complete and short scientific versions and clinical practice and patient versions.
... FM is a condition without cure at this time and with symptoms expected to be lifelong for most. Current guidelines recommend regular physical activity as a critical and necessary treatment strategy for FM; both short-term and longterm benefits of exercise have been demonstrated, emphasizing the need to promote adherence to these recommendations 3,4,5,6 . Nevertheless, continued practice of exercise by FM patients remains poor 7 . ...
... The most studied nonpharmacologic therapies which are all recommended by the guidelines [105][106][107][108][109] are exercise, patient education and psychological treatment, particularly cognitive behavioural therapy (CBT). All encourage a multidisciplinary approach. ...
Fibromyalgia (FM) is the most commonly encountered chronic widespread pain (CWP) condition in rheumatology. In comparison to inflammatory arthritis (IA), it can seem ill defined with no clear understanding of the pathology and therefore no specific targeted treatment. This inevitably raises controversies and challenges. However, this is an outdated view perpetuated by poor teaching of pain at undergraduate and postgraduate levels, and the perennial problem of advances in relevant cross-speciality knowledge penetrating speciality silos. Research has provided a better understanding of the aetiopathology and FM is now regarded as a centralized pain state. Effective treatment is possible utilizing a multidisciplinary approach combining nonpharmacologic and pharmacologic treatments rooted in a biopsychosocial model. This article will provide a review of the mechanisms, diagnosis and treatment of FM, focus on some ongoing contentious issues and propose a change to the diagnostic terminology.
... To date, the need to address symptom management for people diagnosed with FMS has led to the development of treatment guidelines in Canada, 15 Germany, 25 and Israel. 26 As yet, no treatment guidelines have been developed in the United States; the ACR recommends following the Canadian guidelines. 8 All of these guidelines emphasize the importance of patient education and self-care strategies, and all recommend integrating nonpharmacologic with pharmacologic treatment. ...
... Thus, rheumatologists are called upon to perform the workup and differential diagnostic process necessary, both to establish the diagnosis of FMS and, equally importantly, for ruling out other possible explanations for the patient's symptoms. Recently published clinical guidelines (11)(12)(13) have described the basic diagnostic workup recommended for patients being evaluated for FMS. These guidelines stress the fact that once FMS is clinically identified, overzealous investigations should be avoided to limit discomfort, side effects, and cost. ...
Objective:
To evaluate the prevalence of sacroiliitis, the radiographic hallmark of inflammatory spondyloarthropathy, among patients diagnosed with fibromyalgia syndrome (FMS), using the current Assessment of SpondyloArthritis International Society (ASAS) criteria and magnetic resonance imaging.
Methods:
Patients experiencing FMS (American College of Rheumatology 1990 criteria) were interviewed regarding the presence of spondyloarthritis (SpA) features and underwent HLA-B27 testing, C-reactive protein (CRP) level measurement, and magnetic resonance imaging examinations of the sacroiliac joints. FMS severity was assessed by the Fibromyalgia Impact Questionnaire and the Short Form 36 health survey. SpA severity was assessed by the Bath Ankylosing Spondylitis Disease Activity Index.
Results:
Sacroiliitis was demonstrated among 8 patients (8.1%) and ASAS criteria for diagnosis of axial SpA were met in 10 patients (10.2%). Imaging changes suggestive of inflammatory involvement (e.g., erosions and subchondral sclerosis) were demonstrated in 15 patients (17%) and 22 patients (25%), respectively. The diagnosis of axial SpA was positively correlated with increased CRP level and with physical role limitation at recruitment.
Conclusion:
Imaging changes suggestive of axial SpA were common among patients with a diagnosis of FMS. These findings suggest that FMS may mask an underlying axial SpA, a diagnosis with important therapeutic implications. Physicians involved in the management of FMS should remain vigilant to the possibility of underlying inflammatory disorders and actively search for such comorbidities.
... To date, the need to address symptom management for people diagnosed with FMS has led to the development of treatment guidelines in Canada, 15 Germany, 25 and Israel. 26 As yet, no treatment guidelines have been developed in the United States; the ACR recommends following the Canadian guidelines. 8 All of these guidelines emphasize the importance of patient education and self-care strategies, and all recommend integrating nonpharmacologic with pharmacologic treatment. ...
: Evidence-based nonpharmacologic and pharmacologic strategies.
Abstract:
Fibromyalgia syndrome (FMS), one of the most common rheumatic disorders, is estimated to affect up to 15 million people in the United States, 80% to 90% of whom are women. The syndrome is characterized by the presence of chronic widespread pain and various concurrent symptoms, which may include fatigue, cognitive disturbances (memory problems, difficulty concentrating, confusion), distressed mood (anxiety, depression), nonrestorative sleep, and muscular stiffness. Symptom management appears to be best addressed using a multimodal approach, with treatment strategies tailored to the individual. While medication may provide adequate symptom relief for some patients, experts generally recommend integrating both pharmacologic and nonpharmacologic approaches. Some patients may benefit from the adjunctive use of complementary and alternative medicine (CAM) modalities. Because symptom remission is rare and medication adverse effects can complicate symptom management, well-informed nursing care practices and patient education are essential. This article describes the existing treatment guidelines, discusses pharmacologic and nonpharmacologic approaches (including CAM-based modalities), and outlines nursing approaches aimed at enhancing patient self-management.
... This condition is not associated with genuine tissue inflammation and the etiology of the disorder remains poorly understood. FM patients report increased sensitivity to diverse stimuli among them also nociceptive input, which via different mechanisms converge to hypersensitize the central nervous system and in many manners are similar to patients with post-traumatic stress disorder, depression and other affective conditions [19][20][21][22][23][24][25][26]. Among other characteristics FM patients tend to report enhanced olfactory acuity [27]. ...
Patients with autoimmune diseases often present with olfactory impairment. The aim of the study was to assess the olfactory functions of female patients with fibromyalgia (FM) compared with patients with systemic sclerosis (SSc) and with healthy female controls. Olfactory functions were assessed in 24 patients with FM, 20 patients with SSc and 21 age-matched healthy controls. The sense of smell was evaluated using the Sniffin’ Sticks test including the three stages of smell: threshold, discrimination, and identification (TDI) of the different odors. The severity of fibromyalgia was assessed using the fibromyalgia impact questionnaire (FIQ). The short form 36 (SF-36) questionnaire was also completed in order to seek a relationship between the patients perception of quality of life and the different aspects of the smell sense. Depression was evaluated in both FM and SSc patients utilizing the Beck depression inventory-II (BDI-II) questionnaire. Patients with FM had significantly lower TDI smell scores compared with both SSc patients and healthy controls (p
Fibromyalgia (FM) is a condition of chronic widespread pain (CWP) that can occur throughout the life cycle and is likely underrecognized in older patients. FM is associated with considerable suffering and reduction in quality of life and may occur as a unique condition, but in older patients is most likely to be associated with another medical illness. Understood mechanistically to be a sensitization of the nervous system, recently identified as nociplastic pain, FM is accepted as a valid medical illness that requires a positive diagnosis and directed treatments. The cornerstone of treatments for FM are nonpharmacologic interventions, with the understanding that medications provide only modest benefit for most patients, and with particular concern about adverse effects in older patients. If FM is not recognized, treatments may be misdirected to the other medical condition, with failure to address FM symptoms, leading to overall poor outcome. In contrast, new complaints in older patients should not immediately be attributed to FM, and physicians should be vigilant to ensure that onset of a new illness is not ignored. As FM is most often a lifelong condition, patients should be encouraged to identify their own personal strategies that can attenuate symptoms, especially when symptoms flare. Continued life participation should be the outcome goal.
Introduction: Fibromyalgia represents the most prevalent of the group of conditions that are known as central sensitivity syndromes. Approximately 2–5% of the adult population in the United States is affected by Fibromyalgia. This pain amplification syndrome has an enormous economic impact as measured by work absenteeism, decreased work productivity, disability and injury compensation, and over-utilization of healthcare resources. Multiple studies have shown that early diagnosis of this condition can improve patient outlook, and redirect valuable health care resources toward more appropriate targeted therapy. Efforts have been made toward improving diagnostic accuracy through updated criteria.
Areas Covered: Reviewed here are 1) reasons for the need for more accurate diagnosis of Fibromyalgia, (2) a review of the evolution of Fibromyalgia to current times, and (3) the proliferation of currently available diagnostic criteria and problems related to each of them. From initial literature review until October 2020, PubMed, Embase, and Scopus were searched for applicable literature.
Expert Opinion: A discussion of ongoing efforts to obtain a biomarker to enhance diagnostic accuracy concludes this review. A need to include rheumatologists as part of the care team of patients with Fibromyalgia is emphasized.
Despite many advances made in the field of interventional pain management in the past decades, pharmacological therapy often remains the core of the spine pain multimodal treatment. It represents an indispensable therapeutic tool, especially when more interventional methods either failed or are not indicated. This chapter is devoted to describing both neurobiological basis and clinical utility of pharmacological agents used to treat chronic spinal pain. Opioid analgesics have been the mainstay for treatment of pain for centuries. Although opioids may be very useful in treating severe pain conditions, the gravity of their side effects and recently recognized “opioid epidemic” lead to imposing much stricter control of their utilization. NSAIDs (nonsteroidal anti-inflammatory drugs) probably remain the most widely used class of drugs to treat chronic spinal pain because of their ability to reduce pain and inflammation. Centrally acting muscle relaxants are a diverse group of medications with different mechanisms of actions that may be used as an adjuvant treatment, especially when spinal pain is associated with painful muscle spasms. Some antidepressants [tricyclic antidepressants (TCAs) and selective norepinephrine reuptake inhibitors (SNRIs)] have demonstrated their efficacy in treatment of spinal neuropathic pain. Select anticonvulsants, such as gabapentinoids, are also widely used to treat such pain. Topical medications of different classes may have an advantage of exhibiting analgesia without significant systemic absorption. Although there is still insufficient evidence to recommend cannabinoids for spine pain treatment, we discuss this emerging medication class because it has been already used to treat certain pain conditions.
Flexibility exercise training for adults with fibromyalgia This review summarizes the effects of flexibility exercise for adults with fibromyalgia. What problems do fibromyalgia cause? People with fibromyalgia have persistent, widespread body pain. They may also have fatigue, anxiety, depression, and sleep difficulties. What is flexibility exercise training? Flexibility exercise training is a type of exercise that focuses on improving or maintaining the amount of motion available in muscles and joint structures by holding or stretching the body in specific positions. Study characteristics We searched the literature up to December 2017 and found 12 studies (743 individuals) that met our inclusion criteria. Flexibility interventions were compared with control (treatment as usual), aerobic training interventions (e.g. treadmill walking), resistance‐training interventions (e.g. using weight machines that provide resistance to movement), and other interventions (e.g. Pilates). The average age of participants was 48.6 years. Trials were conducted in seven countries, and most studies (58.3%) included only female participants. Exercise trials ranged from 4 to 20 weeks. The stretching exercise programs ranged from 40 to 60 minutes, 1 to 3 times a day. The intensity of the stretches (e.g. how far the stretch was taken in the available range of motion) was not reported in most cases. The time each stretch was held ranged from 6 to 60 seconds. The targeted muscles were usually of both the upper and lower extremities, neck, and back. The flexibility training was either supervised or done at home. Our main comparison was flexibility exercise versus land‐based aerobic training. Key results at the end of treatment for our main comparison Compared with land‐based aerobic exercise training, flexibility exercise resulted in little benefit at 8 to 20 weeks' follow‐up. Each measure below was measured on a scale from 0 to 100, with lower scores better. Health‐related quality of life: People who received flexibility exercise training were 4% worse (ranging from 6% better to 14% worse). • People who had flexibility training rated their quality of life as 46 points. • People who had aerobic training rated their quality of life as 42 points. Pain intensity: People who received flexibility exercise training were 5% worse (ranging from 1% better to 11% worse). • People who had flexibility training rated their pain as 57 points. • People who had aerobic training rated their pain as 52 points. Fatigue: People who received flexibility exercise training were 4% better (ranging from 13% better to 5% worse). • People who had flexibility training rated their fatigue as 67 points. • People who had aerobic training rated their fatigue as 71 points. Stiffness: People who received flexibility exercise training were 30% better (ranging from 8% better to 51% better). • People who had flexibility training rated their stiffness as 49 points. • People who had aerobic training rated their stiffness as 79 points. Physical function: People who received flexibility exercise training were 6% worse (ranging from 4% better to 16% worse). • People who had flexibility training rated their physical function as 23 points. • People who had aerobic training rated their physical function as 17 points. Withdrawal from treatment A total of 18 per 100 people dropped out of the flexibility exercise training group for any reason compared to 19 per 100 people from the aerobic training group. Harms We found no clear information on harms. One study reported that one participant had swelling (tendinitis) of an ankle tendon (Achilles), but it is unclear if this was related to participation in the flexibility exercise. Quality of evidence The evidence does not show that flexibility exercise significantly improves health‐related quality of life, pain, fatigue, or physical function. The number of people dropping out from each group was similar. Although the evidence suggests that flexibility exercise improves stiffness, caution is advised in interpretation of these results, as this improvement was seen in only one study with very few participants. We considered the overall certainty of the evidence to be low to very low due to study design issues, the small number of participants, and low certainty of results.
BACKGROUND AND OBJECTIVES:
Fibromyalgia is a highly relevant theme for research considering its impressive 2% worldwide prevalence, diffuse pain and suffering, largely unknown pathophysiology, scarce odds of cure and, more often than not, poor symptom control. This study aims to review the main options of treatment for fibromyalgia, including some novel alternatives.
CONTENTS:
The pharmacological treatment for fibromyalgia can be prescribed in monotherapy or combination of drugs, which comprises antidepressants, muscle relaxants, anticonvulsants, cannabinoids, opioids, N-methyl D-Aspartate antagonists, melatoninergic agonists, peptidergic substances among others. Non-pharmacological therapies include acupuncture, behavioral (or psychobehavioral) and psychological (or psychotherapy) interventions, physical activity programs, hyperbaric oxygen therapy, ozone therapy, transcranial magnetic stimulation, stretching exercises associated to low intravenous curare doses, among others. Treatment modalities are presented according to possible mechanisms of action, level of scientific evidence and recommendation.
CONCLUSION:
Fibromyalgia therapy should be individualized, and it does not aim the cure. Its objective is to reduce the subject’s suffering; provide function improvement and, as much as possible, the individual’s autonomy and quality of life. There is much in common in most approach recommendations, yet there are some divergence and changes as knowledge is acquired about a theme where consensus is far from being achieved.
Objectives: Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in the United States, Japan, and 37 other countries. The purpose of this article was to provide an in-depth, evidence-based summary of pregabalin for FM as demonstrated in randomized, placebo-controlled clinical studies, including open-label extensions, meta-analyses, combination studies, and post-hoc analyses of clinical study data.
Methods: PubMed was searched using the term ‘pregabalin AND fibromyalgia’ and the Cochrane Library with the term ‘pregabalin’. Both searches were conducted on 2 March 2017 with no other date limits set.
Results: Eleven randomized, double-blind, placebo-controlled clinical studies were identified including parallel group, 2-way crossover, and randomized withdrawal designs. One was a neuroimaging study. Five open-label extensions were also identified. Evidence of efficacy was demonstrated across the studies identified with significant and clinically relevant improvements in pain, sleep quality, and patient status. The safety and tolerability profile of pregabalin is consistent across all the studies identified, including in adolescents, with dizziness and somnolence the most common adverse events reported. These efficacy and safety data are supported by meta-analyses (13 studies). Pregabalin in combination with other pharmacotherapies (7 studies) is also efficacious. Post-hoc analyses have demonstrated the onset of pregabalin efficacy as early as 1–2 days after starting treatment, examined the effect of pregabalin on other aspects of sleep beyond quality, and shown it is effective irrespective of the presence of a wide variety of patient demographic and clinical characteristics.
Conclusions: Pregabalin is a treatment option for FM; its clinical utility has been comprehensively demonstrated.
The heterogeneity of the clinical presentation and the pathophysiologic mechanisms associated with fibromyalgia (FM), and the modest results on average for any therapy, call for a more individualized management strategy. Individualized treatment can be on the basis of subgrouping of patients according to associated conditions (mental health problems, chronic overlapping pain conditions, other somatic diseases) or on disease severity. Categorizing FM as mild, moderate, or severe can be on the basis of clinical assessment (eg, degree of daily functioning) or on questionnaires. Shared decision-making regarding treatment options can be directed according to patient preferences, comorbidities, and availability in various health care settings. The European League Against Rheumatism guidelines recommend a tailored approach directed by FM key symptoms (pain, sleep disorders, fatigue, depression, disability), whereas the German guidelines recommend management tailored to disease severity, with mild disease not requiring any specific treatment, and more severe disease requiring multicomponent therapy (combination of drug treatment with aerobic exercise and psychological treatments). When indicated, treatments should follow a stepwise approach beginning with easily available therapies such as aerobic exercise and amitriptyline. Successful application of a tailored treatment approach that is informed by individual patient characteristics should improve outcome of FM.
Perspective:
This article presents suggestions for an individualized treatment strategy for FM patients on the basis of subgroups and disease severity. Categorizing FM as mild, moderate, or severe can be on the basis of clinical assessment (eg, degree of daily functioning) or questionnaires. Subgroups can be defined according to mental health and somatic comorbidities.
Along with a variety of distressing symptoms, a diagnosis of fibromyalgia (FM) brings with it substantial physical, psychosocial, and financial costs. Research shows that self-management is an effective means to manage FM and can lead to fewer healthcare visits. Yet due to the complexity of this disorder, healthcare providers need to be able to tailor treatment to individual patients by understanding effective treatment interventions. Home healthcare nurses (HHNs) are in a unique position to assess and implement effective treatment recommendations in the home setting and as such could consider incorporating self-management strategies into the home visit with the FM patient. Therefore, the purpose of this article is to use a case study to describe the assessment of FM patient's functional ability and quality of life and how the HHN may integrate self-management teaching into the established home care visit. A review of the literature and discussion of self-management interventions for the FM patient is presented. A summary of the case study and proposed clinical implications is offered.
Objective: Craniomandibular dysfunction (CMD) and craniocervical dysfunction (CCD) are clearly defined musculoskeletal pain syndromes. Relationships with fibromyalgia syndrome (FMS) have not yet been investigated. The aim of the present study is to establish possible relationships between FMS and CMD/ CCD.
Methods: In a retrospective study, 555 patients with CCD and CMD were investigated with respect to the diagnostic criteria of FMS. In addition to otolaryngologic and dental examination, an instrumental functional analysis for the diagnosis of CMD/CCD was performed.
Results: Three hundred fifty-one (63%) of the 555 patients evaluated met the diagnostic criteria for FMS. Seventy-two percent of the patients had a widespread pain index of at least 7 and a severity scale score of at least 5. Twenty-nine percent had a widespread pain index of 3–6 and a severity scale score of at least 9. Using myocentric bite splint therapy and therapy with oral orthesis in combination with neuromuscular relaxation measures, a good to very good improvement of physical symptoms was seen in 84% of CMD-FMS patients, and an improvement of the symptoms in the jaw was achieved in 77% of cases.
Discussion: The substantial proportion of CMD and CCD patients who meet the criteria for FMS emphasizes the complexity of the two diseases. It must be assumed that FMS is a crucial factor for the formation of CMD and CCD. Conversely, CMD/ CCD could also be responsible for diverse clinical pictures of the FMS. FMS patients with synchronous CCD/CMD benefit from an interdisciplinary CMD/CCD treatment.
Fibromyalgia (FM) is a prevalent and costly condition worldwide, affecting approximately 2% of the general population. Recent evidence- and consensus-based guidelines from Canada, Germany, Israel and the European League Against Rheumatism aim to support physicians in achieving a comprehensive diagnostic work-up of patients with chronic widespread pain (CWP) and to assist patients and physicians in shared decision making on treament options. Every patient with CWP requires at the first medical evaluation a complete history, medical examination and some laboratory tests (complete blood count, C-reactive protein, serum calcium, creatine phosphokinase, thyroid stimulating hormone, 25-OH vitamin D) to screen for metabolic or inflammatory causes of CWP. Any additional laboratory or radiographic testing should depend on red flags suggesting some other medical condition. The diagnosis is based on the history of a typical cluster of symptoms (CWP, non-restorative sleep, physical and/or mental fatigue) which cannot be sufficiently explained by another medical condition. Optimal management should begin with patient education regarding the current knowledge of FM (including written materials). Management should be a graduated approach with the aim of improving health-related quality of life. The initial focus should ensure active patient participation in applying healthy lifestyle practices. Aerobic and strengthening exercises should be the foundation of non-pharmacologic management. Cognitive behavioral therapies should be considered for those with mood disorder or inadequate coping strategies. Pharmacological therapies may be considered for those with severe pain (duloxetine, pregabalin, tramadol) or sleep disturbance (amitriptyline, cyclobenzaprine, pregabalin). Multimodal programmes should be considered for those with severe disability.
Perspective:
This article presents an overview and highlights the inconsistencies of 4 recent clinical practice guidelines for treatment of fibromyalgia patients related to study inclusion criteria, outcome measures used, ranking system used, and composition of the review panels. The discrepancies suggest a need to create a guideline consensus to synthesize guidelines.
Background
Longitudinal research on outcomes of patients with fibromyalgia is limited.
Objective
To assess clinician and patient-reported outcomes over time among fibromyalgia patients.
Methods
At enrollment (Baseline) and follow-up (approximately 2 years later), consented patients were screened for chronic widespread pain (CWP), attended a physician site visit to determine fibromyalgia status, and completed an online questionnaire assessing pain, sleep, function, health status, productivity, medications, and healthcare resource use.
Results
Seventy-six fibromyalgia patients participated at both time points (at Baseline: 86.8% white, 89.5% female, mean age 50.9 years, and mean duration of fibromyalgia 4.1 years). Mean number of tender points at each physician visit was 14.1 and 13.5, respectively; 11 patients no longer screened positive for CWP at follow-up. A majority reported medication use for pain (59.2% at Baseline, 62.0% at Follow-up). The most common medication classes were opioids (32.4%), SSRIs (16.9%), and tramadol (14.1%) at Follow-up. Significant mean changes over time were observed for fibromyalgia symptoms (modified American College of Rheumatology 2010 criteria: 18.4 to 16.9; P=0.004), pain interference with function (Brief Pain Inventory-Short Form: 5.9 to 5.3; P=0.013), and sleep (Medical Outcomes Study-Sleep Scale: 58.3 to 52.7; P=0.004). Patients achieving ≥2 point improvement in pain (14.5%) experienced greater changes in pain interference with function (6.8 to 3.4; P=0.001) and sleep (62.4 to 51.0; P=0.061).
Conclusion
Fibromyalgia patients reported high levels of burden at both time points, with few significant changes observed over time. Outcomes were variable among patients over time and were better among those with greater pain improvement.
Background
Craniomandibular dysfunction (CMD) and craniocervical dysfunction (CCD) are clearly defined musculoskeletal pain syndromes of the head and neck region and have a multifactorial origin. The aim of this study was to elucidate possible associations between fibromyalgia syndrome (FMS), CMD and CCD.
Patients and methods
In a retrospective study 966 patients with CCD and CMD, in whom FMS had never been diagnosed, were examined with respect to the diagnostic criteria for FMS. In addition to a classical ear, nose and throat (ENT) medical and dental examination, an obligatory manual medicine investigation as well as a dental, clinical and instrumental functional examination for the diagnostics of CMD and CCD were also performed.
Results
The diagnostic criteria of FMS were fulfilled by 708 (69.8 % female and 30.2 % male) of the 966 patients. The average duration of the pain was 108 months. The average pain intensity was 8.6 (scale 1–10). The mean follow-up observational period was 41 months. By therapy with myocentric occlusal splints, which was carried out simultaneously and combined with neuromuscular relaxation measures, a good to very good improvement in bodily complaints could be achieved in 84 % of the previously therapy-resistant CMD-FMS patients and an improvement in mandibular pain in 88 %.
Discussion
The high proportion of patients with CMD/CCD who fulfilled the diagnostic criteria for FMS, emphasizes the complexity of both diseases. It must be assumed that fibromyalgia is a decisive factor in the development of CMD/CCD and vice versa the CMD/CCD can also be partly responsible for the multitude of complaints in FMS. Patients with FMS and CCD/CMD benefit from a simultaneous interdisciplinary treatment for CMD/CCD.
Objectives:
Current therapeutic approaches to fibromyalgia syndrome (FMS) do not provide satisfactory pain control to a high percentage of patients. This unmet need constantly fuels the pursuit for new modalities for pain relief. This randomised, double-blind, controlled study assessed the efficacy and safety of adding etoricoxib vs. placebo to the current therapeutic regimen of female patients with FMS.
Methods:
In this double-blind, placebo-controlled study, female patients were randomised to receive either 90 mg etoricoxib once daily or placebo for 6 weeks. Several physical and mental parameters were assessed throughout the study. The primary end-point was the response to treatment, defined as ≥ 30% reduction in the average Brief Pain Inventory score. Secondary outcomes were changes in the Fibromyalgia Impact Questionnaire, SF-36 Quality of Life assessment questionnaire and Hamilton rating scales for anxiety and depression.
Results:
Overall, 73 patients were recruited. Although many outcome measures improved throughout the study, no difference was recorded between the etoricoxib- and placebo-treated groups. The Brief Pain Inventory, Fibromyalgia Impact Questionnaire, The Hamilton Anxiety and Depression scores did not differ between the two groups.
Conclusions:
This is the first randomised, double-blind study assessing the effect of adding etoricoxib to pre-existing medications for female patients with FMS. Although being mildly underpowered this study clearly has shown that etoricoxib did not improve pain scores and did not lead to any beneficial mental or physical effects.
Objectives:
Efforts have been made to standardise evidence-based practice, but clinical practice guidelines do not always follow strict development methods. The objective of this review is to identify the current guidelines, analyse the variability of its recommendations and make a synthesis for clinical practice.
Material and methods:
a systematic review of clinical practice guidelines was made in electronic databases and guidelines databases; using "fibromyalgia" AND ["guideline" OR "Clinical Practice guideline"] as terms, from January for 2003 to July of 2013. Guidelines were selected according to the following criteria: a) aimed to fibromyalgia treatment in adults; b) based on scientific evidence, systematically searched; c) evidence levels and strength of recommendation included; d) written in English or Spanish.
Results:
from 249 initial results, six guides fulfilled the inclusion criteria. Clinical practice guidelines analysed in this review show great variability both in the presence and level of evidence and in the strength of recommendation of many treatments. Physical exercise and cognitive-behavioural therapy are first-line treatments, showing high level of evidence. Amitriptyline, used for short periods of time for pain control, is the pharmacologic treatment with the most solid evidence. The multimodal approach reported better results than the isolated application of any treatment.
Conclusions:
Final recommendations in this review identify optimal treatments, facilitating the translation of evidence into practice and enabling more efficient and effective quality care.
Diagnosis of fibromyalgia (FM) remains controversial even though diverse diagnostic criteria have been developed. This review looks at the history, evolution of diagnostic criteria, endless controversy, recent trends and future perspectives regarding FM diagnosis. Some have criticized that diagnosis of FM could lead to medicalization, whereas others have raised concerns of under-diagnosing FM. With the evolution of diagnosis criteria from American College of Rheumatology 1990 to modified American College of Rheumatology 2010, diagnosis of FM has become simpler. The recent trend of applying patient-reported questionnaires has also increased a simpler FM diagnosis. Reliable biomarkers will not be available for the foreseeable future, so diverse assessment tools will have to be used more pro-actively. After initial diagnosis, multiple and comprehensive assessment measures are needed during the course of treatment in order to better understand type and severity of FM symptoms. These, in turn, could help classify FM based on symptom domain, symptom severity, and comorbidity which would enable more personalized treatment.
Treating chronic pain is a complex challenge. While textbooks and medical education classically categorize pain as originating from peripheral (nociceptive), neuropathic, or centralized origins, in real life each and every patient may present a combination of various pain sources, types, and mechanisms. Moreover, individual patients may evolve and develop differing types of pain throughout their clinical follow-up, further emphasizing the necessity to maintain clinical diligence during the evaluation and follow-up of these patients. Rational treatment of patients suffering from chronic pain must attempt at deconstructing complex pain cases, identifying variegate pain generators, and targeting them with appropriate interventions, while incorporating both pharmacological and non-pharmacological strategies, rather than focusing on the total pain level, which represents an integral of all pain types. Failing to recognize the coexistence of different types of pain in an individual patient and escalating medications only on the basis of total pain intensity are liable to lead to both ineffective control of pain and increased untoward effects. In the current review, we outline strategies for deconstructing complex pain and therapeutic suggestions.
Copyright © 2015 Elsevier Ltd. All rights reserved.
Background/PurposeLittle information exists on the comparative patient and economic burden of chronic widespread pain (CWP) and fibromyalgia (FM) in the United States.Methods
This multistage, observational study included an online screening survey of a large geographically diverse US sample to assess CWP status, a physician/site visit to determine FM diagnosis, and an online subject questionnaire to capture clinical characteristics, pain, health status, functioning, sleep, healthcare resource use (HRU), productivity, and costs. Based on the screener and physician evaluation, mutually exclusive groups of subjects without CWP (CWP−), with CWP but without FM (CWP+), and with confirmed FM were identified.ResultsDisease burden was examined in 472 subjects (125 CWP-, 176 CWP+, 171 FM). Age, race, and ethnicity were similar across groups. Mean body mass index and number of comorbidities increased from CWP− to CWP+ to FM (P = 0.0044, P < 0.0001, respectively). From CWP− to CWP+ to FM, there were reductions in health status (EQ-5D, SF-12) and sleep outcomes (MOS-SS, SSQ) (all P < 0.05). Pain severity, interference with function (BPI-SF), and overall work impairment (WPAI:SHP) increased from CWP− to CWP+ to FM (all P < 0.0001). Higher proportions of CWP+ (52.8%) and FM subjects (62.6%) were taking pain-related prescription medications relative to CWP− subjects (32.8%; P < 0.0001). Significant differences in total direct and indirect costs across the three groups (both P < 0.0001) were observed, with highest costs among FM subjects.Conclusion
Fibromyalgia subjects were characterized by the greatest disease burden with more comorbidities and pain-related medications, poorer health status, function, sleep, lower productivity, and higher costs.
Objective
Graduated treatment of patients with functional somatic syndromes (FSS) and fibromyalgia syndrome (FMS) depending on their severity has been recommended by recent guidelines. The Patient Health Questionnaire 15 (PHQ 15) is a validated measure of somatic symptom severity in FSS. We tested the discriminant and transcultural validity of the PHQ 15 as a generic measure of severity in persons with FMS.
Methods
Persons meeting recognized FMS-criteria of the general German population (N = 98), of the US National Data Bank of Rheumatic Diseases (N = 440), and of a single German pain medicine center (N = 167) completed validated self-report questionnaires on somatic and psychological distress (Polysymptomatic Distress scale, Patient Health Questionnaire 4), health-related quality of life (HRQOL) (Short Form Health Survey 12 or 36) and disability (Pain Disability Index). In addition, self-reports of working status were assessed in the clinical setting. Overall severity of FMS was defined by PHQ 15 scores: mild (0–9), moderate (10–14) and severe (15–30).
Results
Persons with mild, moderate and severe FMS did not differ in age and gender. Irrespective of the setting, persons with severe FMS reported more pain sites, fatigue, depressed mood, impaired HRQOL and disability than persons with moderate or mild FMS. Patients with severe FMS in the NDB and in the German clinical center reported more work-related disability than patients with mild FMS.
Conclusion
The PHQ 15 is a valid generic measure of overall severity in FMS.
Whether fibromyalgia syndrome (FMS) can be classified as a somatoform disorder is under debate.
Literature searches on the classification of FMS as a somatoform disorder were performed in Medline and in evidence-based guideline databases.
A somatoform disorder is defined by medically unexplained somatic symptoms that persist for at least 6 months and lead to a significant impairment of the ability to function in everyday life. The nature and extent of the symptoms or the distress and pre-occupation of the patient cannot be explained fully by a general medical condition or by the direct effect of a substance, and are not attributable to another mental disorder. Emotional and psychosocial conflicts play a major role in the onset, severity, exacerbation or maintenance of the physical symptoms. There is disagreement in the FMS research community on the existence of somatic factors sufficiently explaining FMS symptoms. Psychosocial factors play a major role in the onset, exacerbation or maintenance of FMS symptoms in the majority of patients. A biopsychosocial model of interacting biological and psychosocial factors in the predisposition, onset and maintenance of FMS symptoms is more appropriate than the dichotomy between a somatic disease and a mental (somatoform) disorder.
The clinical features of FMS and persistent somatoform pain disorder or somatization disorder according to the International Classification of Diseases (ICD)-10 overlap in individuals with chronic widespread pain without specific somatic disease factors. FMS is not synonymous with somatoform disorder.
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