Randomized controlled trial of a therapeutic intervention group in patients with fibromyalgia syndrome
Marielza Regina Ismael MartinsCristiane Carnaval GrittiRandolfo dos SantosMaria Carolina Luizetto de AraújoLilian Chessa DiasMarcos Henrique Dall ́ Aglio FossLarissa Batista de AndradeCarlos Eduardo Rocha
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To evaluate the efficacy of a weekly interdisciplinary program (WIP) consisted of educational activities, physical therapy, stretching, ergonomics, posture guidance com- bined with cognitive behavioral strategies and approaches to psychosocial and occupa- tional factors in order to determine whether this intervention would be effective to short and medium-term improvement of symptoms in these patients. This was a single-center study, randomized single blind controlled trial with a sample test group (T), with a diagnosis of FMS (n = 12), and a control group (C) subjected to Pain Clinic referral (n = 15). The instruments used at two different times were the Fibromy- algia Impact Questionnaire (FIQ), Visual Analogue Scale (VAS) and Post-Sleep Protocol (PSI). To assess quality of life, we used the SF-12. In samples, both groups were predominantly female, mean age of 42.5 ± 9.8 years, 43% married, average schooling of 8.3 ± 4.5 years. It was reported a mean of 4.2 years pain and an average of two years for the diagnosis of SFM from the group T. There was statisti- cal difference between the groups in terms of efficacy post intervention WIP, in almost all outcome measures. It was found that weekly interdisciplinary program (WIP) has contributed to improving the quality of life of patients with fibromyalgia. Avaliar a eficácia de um programa interdisciplinar semanal (PIS) composto de ati- vidades educativas, terapias físicas, alongamento, ergonomia, orientações posturais com- binado com estratégias cognitivas e comportamentais e abordagens de aspectos psicosso- ciais e ocupacionais, a fim de determinar se esta intervenção seria efetiva em curto e médio prazos para melhora dos sintomas destes pacientes. Trata-se de um estudo unicêntrico, randomizado, simples cego e con- trolado com amostra de um grupo-teste (T), com diagnóstico de SFM (n = 12), e de um grupo-controle (C) submetido a interconsulta na Clínica da Dor (n = 15). Os instrumentos utilizados em dois momentos distintos foram: Questionário de Impacto de Fibromialgia (FIQ), Escala Visual Analógica (EVA) e Protocolo Pós-Sono (PSI). Para avaliar a qualidade de vida, foi utilizado o Questionário SF-12. Na amostra dos dois grupos houve predomínio do gênero feminino, média de idade de 42,5±9,8 anos, 43% casados e média de escolaridade de 8,3±4,5 anos. Foi relatado um tempo médio de dor de 4,2 anos e uma média de dois anos para o diagnóstico de SFM no grupo T. Houve diferença estatística entre os grupos, em relação à eficácia pós-interven- ção do PIS, em quase todos os desfechos analisados. Verificou-se que o programa interdisciplinar semanal (PIS) contribuiu para me- lhora da qualidade de vida dos pacientes fibromiálgicos.Abstract Until recently, nobody knew how many people had fibromyalgia. Several surveys suggest that while 2 percent of the adult U.S. population have full-blown fibromyalgia (3.5 percent of adult women and 0.5 percent of adult men), 11 percent have chronic widespread pain and 20 percent have chronic regional pain. Recently, Dr. Larry Bradley at the University of Alabama has found that for every diagnosed fibromyalgia patient in the United States, there is an undiagnosed individual who has the requisite tender points, but never seeks medical attention for this. This has been termed community fibromyalgia. A survey in Great Britain found that 13 percent of the population had chronic widespread pain, 72 percent of whom sought medical attention for it. Of those, 21 percent fulfilled the ACR criteria for fibromyalgia. In other words, of individuals with chronic neuromuscular pain, less than half have diagnosed fibromyalgia or community fibromyalgia. Fibromyalgia is the third or fourth most common reason for consulting a rheumatologist. Approximately 15–20 percent of all patients seeking rheumatology referrals have fibromyalgia. The 5,000 rheumatologists in the United States who are trained in internal medicine and subspecialize in managing more than 150 musculoskeletal and immune system disorders are very familiar with the diagnosis and treatment of fibromyalgia.
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Abstract To develop criteria for the classification of fibromyalgia, we studied 558 consecutive patients: 293 patients with fibromyalgia and 265 control patients. Interviews and examinations were performed by trained, blinded assessors. Control patients for the group with primary fibromyalgia were matched for age and sex, and limited to patients with disorders that could be confused with primary fibromyalgia. Control patients for the group with secondary‐concomitant fibromyalgia were matched for age, sex, and concomitant rheumatic disorders. Widespread pain (axial plus upper and lower segment plus left‐ and right‐sided pain) was found in 97.6% of all patients with fibromyalgia and in 69.1% of all control patients. The combination of widespread pain and mild or greater tenderness in ⩾ 11 of 18 tender point sites yielded a sensitivity of 88.4% and a specificity of 81.1%. Primary fibromyalgia patients and secondary‐concomitant fibromyalgia patients did not differ statistically in any major study variable, and the criteria performed equally well in patients with and those without concomitant rheumatic conditions. The newly proposed criteria for the classification of fibromyalgia are 1) widespread pain in combination with 2) tenderness at 11 or more of the 18 specific tender point sites. No exclusions are made for the presence of concomitant radiographic or laboratory abnormalities. At the diagnostic or classification level, the distinction between primary fibromyalgia and secondary‐concomitant fibromyalgia (as defined in the text) is abandoned.
Concomitant
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Abstract Objective. To determine the frequency of a precipitating event occurring prior to the onset of fibromyalgia syndrome, in a consecutive series of patients. Outcome in patients in whom there was a causative factor was compared with that in patients with primary fibromyalgia. Methods. Records of patients presenting over a 4‐year period who fulfilled criteria for fibromyalgia were reviewed, and patients were classified as having reactive fibromyalgia if a specific event prior to the onset of illness could be identified. Outcome features, including employment status and disability compensation, were compared in patients with reactive fibromyalgia versus those with primary fibromyalgia. Results. Twenty‐nine of 127 patients (23%) with a primary rheumatologic diagnosis of fibromyalgia reported having trauma, surgery, or a medical illness before the onset of fibromyalgia, and were classified as having reactive fibromyalgia. Patients in this group were more disabled than those with primary fibromyalgia, resulting in loss of employment in 70%, disability compensation in 34%, and reduced physical activity in 45% Conclusion. The development of fibromyalgia after a precipitating event may represent the onset of a prolonged and disabling pain syndrome with considerable social and economic implications.
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Position paper
Fibromyalgia syndrome
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This journal recently published a paper by Sleurs et al., entitled ‘Comorbidities of self-reported fibromyalgia in United States adults: A cross-sectional study from The National Epidemiological Survey on Alcohol and Related Conditions (NESARC-III). (Sleurs, Tebaka, Scognamiglio, Dubertret, & lLe strat, 2020)’. While its primary message is that persons reporting a physician diagnosis of fibromyalgia have very high rates of physical and mental comorbidities, this study provides other important information on the nature and validity of fibromyalgia and fibromyalgia diagnosis, as it is likely the most of the reported fibromyalgia patients in the study would not satisfy criteria for fibromyalgia. In the clinic, diagnosis of fibromyalgia is in ‘the eye of the beholder’. Close to 20 years ago George Ehrlich observed that ‘no one has FM until it is diagnosed’—that diagnosis is arbitrary. A striking result of the Sleurs et al. epidemiological study is the observation that 87.5% of those with reported fibromyalgia are women, confirming results from other population derived estimates of physician diagnosed fibromyalgia. In contrast, population-based studies applying current published criteria have found that around 60% or fewer fibromyalgia patients are women (Häuser, Brähler, Ablin, & Wolfe, 2020). In addition, we know from multiple studies that most clinically diagnosed patients do not satisfy criteria for fibromyalgia, and in a recent population study only 14.6% of persons who satisfied published criteria for fibromyalgia had received a clinical diagnosis of fibromyalgia (Häuser et al., 2020). Presumably, had such persons been interviewed in the Sleurs et al. study they would not have been included as fibromyalgia patients. Data such as these underscore problems of fibromyalgia definition and diagnosis. Fibromyalgia can be an arbitrary diagnosis. It appears to be diagnosed disproportionally in women and almost never thought of in men and, if multiple studies are correct, most community diagnosed fibromyalgia patients may not even satisfy fibromyalgia criteria. In studies where published criteria are applied, many patients diagnosed with one set of criteria will not be the same as those diagnosed with another set (Häuser et al., 2020)? Readers might reasonably ask, ‘What is fibromyalgia’? Do other characteristics, such as sex, mental symptoms and social factors influence the diagnosis and definition of fibromyalgia? This study throws light on another important issue. What are we to make of the extremely high rates of mental illness and physical comorbidity in those with fibromyalgia in this study? One hundred percent of reported fibromyalgia cases had at least one physical disorder, 68% had four or more disorders, 67% reported ‘arthritis’ and 80% were found to have a mental disorder. Some might try to separate these patients into primary of secondary fibromyalgia groupings, though it would seem clear that trying to guess the specific causal path would be hazardous. According to the authors, ‘The strengths of the relationships between mental disorders and self-reported fibromyalgia in our study support the hypothesis of central sensitization in fibromyalgia’. However, readers should be aware that current knowledge does not allow for the fibromyalgia sensitization hypothesis to be falsified, and mental and physical illness could be the cause or result (or some mixture) of fibromyalgia—a disorder that has no gold standard and whose definition has changed repeated over the last 60 years. We recently reported a similar study of self-reported physical and mental comorbidities in 12,215 patients in a research databank (Wolfe, Ablin, Guymer, Littlejohn, & Rasker, 2020), and obtained results similar to those of this study. Using a criteria-based definition of fibromyalgia as well as the quantitative measure of fibromyalgia severity, the polysymptomatic distress (PSD) scale, we found that criteria-based fibromyalgia as well as PSD were associated with an increase in the number of comorbidities. In addition, we found the association of PSD was present above and below the fibromyalgia diagnostic cut point. That is the degree of fibromyalgia-like symptom severity is more important than the presence or absence of fibromyalgia. Readers should also know that patients with fibromyalgia in this study are likely to satisfy diagnoses that fall under the rubric of bodily distress and other functional somatic syndromes. The main difference between these syndromes and fibromyalgia is the organizational beliefs and medical specialties of those making diagnoses and performing research. Considering fibromyalgia symptoms quantitatively with the PSD avoids the problems inherent with diagnostic and selection bias. In addition, it sidesteps the issue of central sensitivity attributions associated with diagnosis since if applies to the entire spectrum of patient symptom severity. No one argues about fibromyalgia symptoms. Instead the controversy regarding fibromyalgia is how to classify and understand the symptoms and their social meaning. It is unfortunate that the authors of this very important current study were unable to administer the PSD, as it would have further defined the nature of comorbidity in symptomatic patients. We advise that this simple scale—which also provides a fibromyalgia diagnosis for those who require it—be used in future similar studies. None declared. None declared.
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Fibromyalgia has previously been categorized as primary, secondary, and juvenile fibromyalgia. However, these definitions do not adequately explain the etiopathology of disease, nor do they help direct new specific therapies. Herein, we review the previously known categorizations of fibromyalgia. Based on common patient characteristics and previously studied pathophysiologies, we propose new subcategorizations of fibromyalgia that we have self-narrated, including hormonal fibromyalgia, neuroendocrine fibromyalgia, psychologic fibromyalgia, inflammatory fibromyalgia, and lastly, neuropathic fibromyalgia. Future research needs to be done to verify, add to, and fully describe these self-narrated categories of fibromyalgia that we have proposed.
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Objectives: Although there are studies in the literature about how Behçet's disease is affected in the presence of fibromyalgia, there is no information about how the severity of fibromyalgia is in the presence of Behçet's disease. This study aims to evaluate the severity of fibromyalgia by comparing the impact of fibromyalgia and pain thresholds between fibromyalgia patients with and without Behçet's disease. Methods: Twenty-five fibromyalgia patients with Behçet's disease and 34 primary fibromyalgia patients were included in this cross-sectional study. All participants completed the fibromyalgia impact questionnaire, and pain thresholds were measured at 18 tender points using algometry. Results: The mean fibromyalgia impact questionnaire scores in fibromyalgia patients with and without Behçet's disease were 66.6 ± 18.4 and 60.4 ± 14.5, respectively (p = 0.157). Pain thresholds were not different between the groups in 15 of the 18 tender points (TP). In fibromyalgia patients with Behçet's disease, pain thresholds in TP-15, TP-16 and TP-17 were 11.44 ± 4.84, 11.92 ± 5.00 and 15.16 ± 4.89 pounds, respectively, while in primary fibromyalgia patients those were 8.41 ± 2.68, 8.14 ± 2.76 and 12.14 ± 4.06 pounds respectively. Pain thresholds in TP-15, TP-16 and TP-17 were significantly different between the groups (p = 0.003, p = 0.003, p = 0.014, respectively). Conclusions: According to the literature data, although fibromyalgia has an effect on Behçet's disease, especially in cases associated with central sensitization syndromes, the severity of fibromyalgia was not found to be different in fibromyalgia patients with and without Behçet's disease in this study. There may be a relationship between Behçet's disease and fibromyalgia due to non-inflammatory causes such as central sensitization.
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To document 1) the content validity and 2) measure improvements in fatigue, using the Fatigue Visual Analogue Scale (VAS) assessment tool in patients with fibromyalgia.The relevance and comprehensiveness of the Fatigue VAS were tested through a qualitative analysis of 20 subjects' verbatim transcripts from semi-structured qualitative interviews. Data from two randomised, controller trials in fibromyalgia (n=1121) were used to conduct correlation analyses with the Fatigue and Tiredness items from the Fibromyalgia Impact Questionnaire (FIQ) and the Short Form-36 Vitality scale. Known-groups and cross classification analyses were conducted to demonstrate the ability to measure improvement in fatigue using the Fatigue VAS.All subjects spontaneously reported that fatigue was an important symptom to capture in fibromyalgia. The Fatigue VAS was well understood by most subjects (n=18/20). High correlations (Pearson r>0.75) and good agreement (k>0.66) were found between the Fatigue VAS and the FIQ tiredness items no. 16 and 17 and SF-36™ Vitality scale. In both clinical trials there was a substantial separation of approximately 20 points on the mean change in the Fatigue VAS score between responders (>30% improvement in pain VAS) and non-responders.Previous studies have confirmed that fatigue is a major component of the fibromyalgia experience. This current study reports that fibromyalgia patients spontaneously rated fatigue as a highly significant feature of their illness, and supports the use of the Fatigue VAS as a valid questionnaire in fibromyalgia clinical trials.
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Fibromyalgia was almost completely absent from an urban affluent population compared with poor urban and rural communities. Seventeen percent of Gulf War veterans with soft tissue syndromes had fibromyalgia, a much higher rate than was seen in previous studies of rheumatic disease in the military population. A state of central hyperexcitability in the nociceptive system was reported in fibromyalgia. Altered functioning of the stress-response system has been further documented in fibromyalgia and chronic fatigue syndrome. Administration of growth hormone to patients with fibromyalgia who have low levels of insulinlike growth factor 1 resulted in improvement in their symptoms and tenderness. An association between chronic fatigue syndrome and initial infections was demonstrated. A correlation between particular immunologic abnormalities and measures of disease severity was documented in chronic fatigue syndrome. Concomitant fibromyalgia in other rheumatic diseases was a major contributor to poor quality of life. A favorable outcome of fibromyalgia in children was reported; the majority of patients improved over 2 to 3 years of follow-up. Treatment of patients with fibromyalgia continues to be of limited success.
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Dr. Mary-Ann Fitzcharles from McGill University Health Center moderated the topic Fibromyalgia: New Clinical Concepts with Drs. Frederick Wolfe from the University of Kansas School of Medicine, Winfried Hauser from Technische Universitat Munchen, and Brian Walitt from the Georgetown University Medical Center participating The discussion focused primarily on: The evolution and changing concepts of fibromyalgia; the criteria for diagnosis of fibromyalgia emphasizing the subjective nature of symptoms; the great variation in symptomatology among fibromyalgia patients; pharmacological and nonpharmacological treatment for fibromyalgia and the importance of the latter; the long-term outcomes for fibromyalgia patients; the appropriate goals and expectations of fibromyalgia treatment; and the societal and legal implications of the diagnosis of fibromyalgia. Med Roundtable Gen Med Ed. 2013;2(1):e26–e33.
Center (category theory)
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