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1.  Fibromyalgia, Systemic Lupus Erythematosus (SLE) and the Evaluation of SLE Activity 
The Journal of rheumatology  2009;36(1):82-88.
Purpose
To determine if fibromyalgia or fibromyalgianess is increased in SLE compared with non-SLE patients, whether fibromyalgia or fibromyalgianess (the tendency to respond to illness and psychosocial stress with fatigue, widespread pain, general increase in symptoms and similar factors ) biases the Systemic Lupus Erythematosus Activity Questionnaire (SLAQ), and to determine if the SLAQ is overly sensitive to fibromyalgia symptoms.
Method
We developed a 16-item SLE symptom scale (SLESS) modeled on the SLAQ and used that scale to investigate the relation between SLE symptoms and fibromyalgianess in 23,321 rheumatic disease patients. Fibromyalgia was diagnosed by survey fibromyalgia criteria and fibromyalgianess was measured using the Symptom Intensity Scale (SI). As comparison groups, we combined patients with rheumatoid arthritis (RA) and non-inflammatory rheumatic disorders into an “arthritis” group and also utilized a physician-diagnosed group of fibromyalgia patients.
Results
Fibromyalgia was identified in 22.1% of SLE and 17.0% of those with arthritis. The SI scale was minimally increased in SLE. The correlation between SLAQ and SLESS was 0.738. SLESS/SLAQ scale items: Raynaud’s, rash, fever, easy bruising and hair loss were significantly more associated with SLE than fibromyalgia, while the reverse was true for headache, abdominal pain, paresthesias/stroke, fatigue, cognitive problems and muscle pain or weakness. There was no evidence of a disproportionate symptom reporting associated with fibromyalgianess. Self-reported SLE was associated with an increased prevalence of fibromyalgia when unconfirmed by physicians compared to SLE confirmed by physicians.
Conclusions
The prevalence of fibromyalgia in SLE is minimally increased compared with its prevalence in patients with arthritis. Fibromyalgianess does not bias the SLESS and should not bias SLE assessments, including the SLAQ.
doi:10.3899/jrheum.080212
PMCID: PMC2944223  PMID: 19004039
Systemic Lupus Erythematosus; Fibromyalgia; Systemic Lupus Erythematosus Activity Questionnaire; SLAQ; SLAM
2.  The quality of websites addressing fibromyalgia: an assessment of quality and readability using standardised tools 
BMJ Open  2011;1(1):e000152.
Background
Patients living with fibromyalgia strongly prefer to access health information on the web. However, the majority of subjects in previous studies strongly expressed their concerns about the quality of online information resources.
Objectives
The purpose of this study was to evaluate existing online fibromyalgia information resources for content, quality and readability by using standardised quality and readability tools.
Methods
The first 25 websites were identified using Google and the search keyword ‘fibromyalgia’. Pairs of raters independently evaluated website quality using two structured tools (DISCERN and a quality checklist). Readability was assessed using the Flesch Reading Ease score maps.
Results
Ranking of the websites' quality varied by the tool used, although there was general agreement about the top three websites (Fibromyalgia Information, Fibromyalgia Information Foundation and National Institute of Arthritis and Musculoskeletal and Skin Diseases). Content analysis indicated that 72% of websites provided information on treatment options, 68% on symptoms, 60% on diagnosis and 40% on coping and resources. DISCERN ratings classified 32% websites as ‘very good’, 32% as ‘good and 36% as ‘marginal’. The mean overall DISCERN score was 36.88 (good). Only 16% of websites met the recommended literacy level grade of 6–8 (range 7–15).
Conclusion
Higher quality websites tended to be less readable. Online fibromyalgia information resources do not provide comprehensive information about fibromyalgia, and have low quality and poor readability. While information is very important for those living with fibromyalgia, current resources are unlikely to provide necessary or accurate information, and may not be usable for most people.
Article summary
Article focus
The purpose of the study was to gain a better understanding of the online information resources available for people with fibromyalgia and to evaluate those resources for content, quality and readability.
To determine the content, website quality and readability of the most readily retrieved information available on the web when searching for fibromyalgia information.
Key messages
Most existing websites do not provide comprehensive information on fibromyalgia.
Websites are highly variable in terms of quality.
Higher quality websites do not present information in language/reading levels appropriate for the general population.
Strengths and limitations of this study
This study examines the quality of online fibromyalgia resources.
Standardised quality and readability tools were used to assess quality and readability.
There is no gold standard for comparison or ways to evaluate the quality of websites.
The quality issue was discussed using critical appraisal tools designed for the lay public.
The readability score may vary for some websites as it may be related to the use of technical terms such as fibromyalgia.
doi:10.1136/bmjopen-2011-000152
PMCID: PMC3191440  PMID: 22021777
3.  Personality and Fibromyalgia Syndrome 
Objectives:
We aimed to review how personality characteristics contribute to the onset, maintenance or modulation of fibromyalgia.
Method:
The databases Medline and PsychINFO were examined from 1967 to 2012 to identify studies that investigated associations between fibromyalgia and personality. Search terms included fibromyalgia and personality, trait psychology, characteristics and individual differences.
Results:
Numerous studies indicate that patients with fibromyalgia experience psychological distress. Various instruments have been used to evaluate distress and related psychological domains, such as anxiety or depression, in fibromyalgia. In many cases, these same instruments have been used to study personality characteristics in fibromyalgia with a subsequent blurring of cause and effect between personality and psychological distress. In addition, the symptoms of fibromyalgia may change pre-illness personality characteristics themselves. These issues make it difficult to identify specific personality characteristics that might influence the fibromyalgia process. Despite this inherent problem with the methodologies used in the studies that make up this literature review, or perhaps because of it, we found no defined personality profile specific to fibromyalgia. However, many patients with fibromyalgia do show personality characteristics that facilitate psychological responses to stressful situations, such as catastrophising or poor coping techniques, and these in turn associate with mechanisms contributing to fibromyalgia.
Conclusion:
No specific fibromyalgia personality is defined but it is proposed that personality is an important filter that modulates a person’s response to psychological stressors. Certain personalities may facilitate translation of these stressors to physiological responses driving the fibromyalgia mechanism.
doi:10.2174/1874312901206010273
PMCID: PMC3447191  PMID: 23002409
Fibromyalgia; personality; stress; psychology; instruments.
4.  Prevalence of Fibromyalgia: A Population-Based Study in Olmsted County, Minnesota, Utilizing the Rochester Epidemiology Project 
Arthritis care & research  2013;65(5):786-792.
Objective
Our objective was to estimate and compare the prevalence of fibromyalgia by two different methods, in Olmsted County, Minnesota.
Methods
The first method was a retrospective review of medical records of potential cases of fibromyalgia in Olmsted County using Rochester Epidemiology Project (from January 1, 2005, to December 31, 2009) to estimate the prevalence of diagnosed fibromyalgia in clinical practice. The second method was a random survey of adults in Olmsted County using the fibromyalgia research survey criteria to estimate the percentage of responders who met fibromyalgia research survey criteria.
Results
Of the 3,410 potential patients identified by the first method, 1,115 had a fibromyalgia diagnosis documented in the medical record by a health care provider. The age- and sex-adjusted prevalence of diagnosed fibromyalgia by this method was 1.1%. By the second method, of the 2,994 people who received the survey by mail, 830 (27.6%) responded and 44 (5.3%) met fibromyalgia research survey criteria. The age- and sex-adjusted prevalence of fibromyalgia in the general population of Olmsted County by this method was estimated at 6.4%.
Conclusion
To the best of our knowledge, this is the first report of the rate at which fibromyalgia is being diagnosed in a community. This is also the first report of prevalence as assessed by the fibromyalgia research survey criteria. Our results suggest that patients, particularly men, who meet the fibromyalgia research survey criteria are unlikely to have been given a diagnosis of fibromyalgia.
doi:10.1002/acr.21896
PMCID: PMC3935235  PMID: 23203795
Fibromyalgia; gender; population studies
5.  Disability and quality of life in patients with fibromyalgia 
Background
Patients with fibromyalgia often feel disabled in the performance of daily activities. Psychological factors seem to play a pronounced disabling role in fibromyalgia.
The objectives of the study are: Firstly, to investigate contributing factors for disability in fibromyalgia. Secondly, to study psychological distress in patients with fibromyalgia as compared to other nonspecific pain syndromes. And finally, to explore the impact of fibromyalgia on a patient's quality of life.
Methods
In this cross sectional study, explaining factors for disability were studied based on a regression analysis with gender, mental health, physical and social functioning as independent variables. For the assessment of disability in fibromyalgia the FIQ was used. The levels of psychological distress in patients with fibromyalgia, Complex Regional Pain Syndrome (CRPS) and chronic low back pain (CLBP) were compared based on scores on the Symptom Checklist (SCL90). Quality of life of patients with fibromyalgia was compared with scores (SF36) of both patients with fibromyalgia and other health conditions as derived from the literature.
Results
Disability in fibromyalgia seemed best explained by a patients mental health condition (β = -0.360 p = 0.02). The level of psychological distress was higher in patients with fibromyalgia as compared to patients with CRPS or CLBP (p < 0.01). The impact of fibromyalgia on quality of life appeared to be high as compared to the impact of other health conditions.
Conclusion
Patients with fibromyalgia report a considerable impact on their quality of life and their perceived disability level seems influenced by their mental health condition. In comparison with patients with other pain conditions psychological distress is higher.
doi:10.1186/1477-7525-6-8
PMCID: PMC2265693  PMID: 18211701
6.  The PedsQL™ as a patient-reported outcome in children and adolescents with fibromyalgia: an analysis of OMERACT domains 
Background
Fibromyalgia is a chronic health condition characterized by widespread musculoskeletal pain, multiple tender points on physical examination, generalized muscular aching, stiffness, fatigue, nonrestorative sleep pattern, cognitive dysfunction, and mood disturbance. Recently, the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Fibromyalgia Syndrome Workshop ranked and prioritized the domains that should be consistently measured in fibromyalgia clinical trials, specifically, pain, generic health-related quality of life, fatigue, sleep quality, and physical function. The focus of these deliberations was exclusively on adult patients, and to our knowledge, these domains have not been previously tested within a multidimensional framework in children and adolescents with fibromyalgia.
Methods
An analysis to determine the feasibility, reliability, and validity of the PedsQL™ 4.0 (Pediatric Quality of Life Inventory™) Generic Core Scales, PedsQL™ Multidimensional Fatigue Scale, and PedsQL™ Rheumatology Module Pain and Hurt Scale as patient-reported outcome (PRO) measures for pediatric patients with fibromyalgia. The PedsQL™ Scales were completed by 59 families in a pediatric rheumatology clinic in a large children's hospital.
Results
The PedsQL™ evidenced minimal missing responses (0.53% patient self-report, 0.70% parent proxy-report), achieved excellent reliability for the Generic Core Scales Total Scale Score (α = 0.88 patient self-report, 0.87 parent proxy-report), the Multidimensional Fatigue Scale Total Scale Score (α = 0.94 patient self-report, 0.94 parent proxy-report), and acceptable reliability for the 4-item Rheumatology Module Pain and Hurt Scale (α = 0.68 patient self-report, 0.75 parent proxy-report). The PedsQL™ Generic Core Scales and Multidimensional Fatigue Scale significantly distinguished between pediatric patients with fibromyalgia and healthy children. Pediatric patients with fibromyalgia self-reported severely impaired physical and psychosocial functioning, significantly lower on most dimensions when compared to pediatric cancer patients receiving cancer treatment, and significantly lower on all dimensions than pediatric patients with other rheumatologic diseases. Patients with fibromyalgia self-reported significantly greater pain and fatigue than pediatric patients with other rheumatologic conditions, and generally more fatigue than pediatric patients receiving treatment for cancer.
Conclusion
The results demonstrate the excellent measurement properties of the PedsQL™ Scales in fibromyalgia. These PedsQL™ Scales measure constructs consistent with the recommended OMERACT Fibromyalgia Syndrome Workshop domains. The findings highlight the severely impaired HRQOL of pediatric patients with fibromyalgia. Regular monitoring of pediatric patients with fibromyalgia will help identify children and adolescents at risk for severely impaired HRQOL. These PedsQL™ Scales are appropriate outcome measures for clinical trials and health services research for pediatric patients with fibromyalgia.
doi:10.1186/1477-7525-5-9
PMCID: PMC1802070  PMID: 17295915
7.  A patient survey of the impact of fibromyalgia and the journey to diagnosis 
Background
Fibromyalgia is a painful, debilitating illness with a prevalence of 0.5-5.0% that affects women more than men. It has been shown that the diagnosis of fibromyalgia is associated with improved patient satisfaction and reduced healthcare utilization. This survey examined the patient journey to having their condition diagnosed and studied the impact of the condition on their life.
Methods
A questionnaire survey of 800 patients with fibromyalgia and 1622 physicians in 6 European countries, Mexico and South Korea. Patients were recruited via their physician.
Results
Over half the patients (61%) were aged 36-59 years, 84% were women, and the mean time since experiencing fibromyalgia symptoms was 6.5 years. Patients had experienced multiple fibromyalgia symptoms (mean of 7.3 out of 14), with pain, fatigue, sleeping problems and concentration difficulties being the most commonly reported. Most patients rated their chronic widespread pain as moderate or severe and fibromyalgia symptoms were on average "fairly" to "very" disruptive, and had a "moderate" to "strong" impact on patients' lives. 22% were unable to work and 25% were not able to work all the time because of their fibromyalgia. Patients waited on average almost a year after experiencing symptoms before presenting to a physician, and it took an average of 2.3 years and presenting to 3.7 different physicians before receiving a diagnosis of fibromyalgia. Patients rated receiving a diagnosis as somewhat difficult on average and had difficulties communicating their symptoms to the physician. Over one third (35%) felt their chronic widespread pain was not well managed by their current treatment.
Conclusions
This survey provides further evidence that fibromyalgia is characterized by multiple symptoms and has a notable impact on quality of life and function. The diagnosis of fibromyalgia is delayed. Patients wait a significant period of time before presenting to a physician, adding to the prolonged time to diagnosis. Patients typically present with a multitude of symptoms, all resulting in a delay in diagnosis and eventual management. Helping clinicians to diagnose and manage patients with fibromyalgia should benefit both patients and funders of healthcare.
doi:10.1186/1472-6963-10-102
PMCID: PMC2874550  PMID: 20420681
8.  Joint hypermobility and fibromyalgia in schoolchildren. 
Annals of the Rheumatic Diseases  1993;52(7):494-496.
OBJECTIVES--To test the hypothesis that joint hypermobility may play a part in the pathogenesis of pain in fibromyalgia, schoolchildren were examined for the coexistence of joint hypermobility and fibromyalgia. METHODS--The study group consisted of 338 children (179 boys, 159 girls; mean age 11.5 years, range 9-15 years) from one public school in Beer-Sheva, Israel. In the assessment of joint hypermobility, the criteria devised by Carter and Bird were used. Any child who met at least three of five criteria was considered to have joint hypermobility. Children were considered to have fibromyalgia if they fulfilled the 1990 American College of Rheumatology criteria for the diagnosis of fibromyalgia, namely, widespread pain in combination with tenderness of 11 or more of the 18 specific tender point sites. The blind assessments of joint hypermobility (by AG) and fibromyalgia (by DB) were carried out independently. RESULTS--Of the 338 children 43 (13%) were found to have joint hypermobility and 21 (6%) fibromyalgia; 17 (81%) of the 21 with fibromyalgia had joint hypermobility and 17 (40%) of the 43 with joint hypermobility had fibromyalgia. Using chi 2 statistical analysis, joint hypermobility and fibromyalgia were found to be highly associated. CONCLUSIONS--This study suggests that there is a strong association between joint hypermobility and fibromyalgia in schoolchildren. It is possible that joint hypermobility may play a part in the pathogenesis of pain in fibromyalgia. More studies are needed to establish the clinical significance of this observation.
PMCID: PMC1005086  PMID: 8346976
9.  Patient Perspectives on the Impact of Fibromyalgia 
Patient education and counseling  2008;73(1):114-120.
Objective
The objective of this study was to elicit and assess important symptom domains and the impact of fibromyalgia on patients’ quality of life and functioning from a patient’s perspective. The intention was to collect this information as part of an overall effort to overcome shortcomings of existing outcome measures in fibromyalgia.
Methods
This was a qualitative study in which six focus group sessions with 48 women diagnosed with fibromyalgia were conducted to elicit concepts and ideas to assess the impact of fibromyalgia on their lives.
Results
The focus groups conducted with fibromyalgia patients identified symptom domains that had the greatest impact on their quality of life including pain, sleep disturbance, fatigue depression, anxiety, and cognitive impairment. Fibromyalgia had a substantial negative impact on social and occupational function. Patients reported disrupted relationships with family and friends, social isolation, reduced activities of daily living and leisure activities, avoidance of physical activity, and loss of career or inability to advance in careers or education.
Conclusion
The findings from the focus groups revealed that fibromyalgia has a substantial negative impact on patients’ lives.
Practice Implications
A comprehensive assessment of the multiple symptoms domains associated with fibromyalgia and the impact of fibromyalgia on multidimensional aspects of function should be a routine part of the care of fibromyalgia patients.
doi:10.1016/j.pec.2008.06.005
PMCID: PMC2564867  PMID: 18640807
fibromyalgia; patient focus group; symptom domains; quality of life
10.  Mitochondrial dysfunction and mitophagy activation in blood mononuclear cells of fibromyalgia patients: implications in the pathogenesis of the disease 
Introduction
Fibromyalgia is a chronic pain syndrome with unknown etiology. Recent studies have shown some evidence demonstrating that oxidative stress may have a role in the pathophysiology of fibromyalgia. However, it is still not clear whether oxidative stress is the cause or the effect of the abnormalities documented in fibromyalgia. Furthermore, the role of mitochondria in the redox imbalance reported in fibromyalgia also is controversial. We undertook this study to investigate the role of mitochondrial dysfunction, oxidative stress, and mitophagy in fibromyalgia.
Methods
We studied 20 patients (2 male, 18 female patients) from the database of the Sevillian Fibromyalgia Association and 10 healthy controls. We evaluated mitochondrial function in blood mononuclear cells from fibromyalgia patients measuring, coenzyme Q10 levels with high-performance liquid chromatography (HPLC), and mitochondrial membrane potential with flow cytometry. Oxidative stress was determined by measuring mitochondrial superoxide production with MitoSOX™ and lipid peroxidation in blood mononuclear cells and plasma from fibromyalgia patients. Autophagy activation was evaluated by quantifying the fluorescence intensity of LysoTracker™ Red staining of blood mononuclear cells. Mitophagy was confirmed by measuring citrate synthase activity and electron microscopy examination of blood mononuclear cells.
Results
We found reduced levels of coenzyme Q10, decreased mitochondrial membrane potential, increased levels of mitochondrial superoxide in blood mononuclear cells, and increased levels of lipid peroxidation in both blood mononuclear cells and plasma from fibromyalgia patients. Mitochondrial dysfunction was also associated with increased expression of autophagic genes and the elimination of dysfunctional mitochondria with mitophagy.
Conclusions
These findings may support the role of oxidative stress and mitophagy in the pathophysiology of fibromyalgia.
doi:10.1186/ar2918
PMCID: PMC2875645  PMID: 20109177
11.  Real-world comparison of health care utilization between duloxetine and pregabalin initiators with fibromyalgia 
Journal of Pain Research  2014;7:37-46.
Objectives
To compare health care utilization of duloxetine initiators and pregabalin initiators among fibromyalgia patients in a real-world setting.
Methods
A retrospective cohort study was conducted based on a US national commercial health claims database (2006–2009). Fibromyalgia patients who initiated duloxetine or pregabalin in 2008, aged 18–64 years, and who maintained continuous health insurance coverage 1 year before and 1 year after initiation were assigned to duloxetine or pregabalin cohorts on the basis of their initiated agent. Patients who had pill coverage of the agents over the course of 90 days preceding the initiation were excluded. The two comparative cohorts were constructed using propensity score greedy match methods. Descriptive analysis and paired t-test were performed to compare health care utilization rates in the postinitiation year and the changes of these rates from the preinitiation year to the postinitiation year.
Results
Both matched cohorts (n=1,265 pairs) had a similar mean initiation age (49–50 years), percentage of women (87%–88%), and prevalence of baseline comorbid conditions (neuropathic pain other than diabetic peripheral neuropathic pain, low back pain, cardiovascular disease, hypertension, headache or migraine, and osteoarthritis). In the preinitiation year, both cohorts had similar inpatient, outpatient, and medication utilization rates (inpatient, 15.7%–16.1%; outpatient, 100.0%; medication, 97.9%–98.7%). The utilization rates diverged in the postinitiation year, with the pregabalin cohort using more fibromyalgia-related inpatient care (3.2% versus 2.2%; P<0.05), any inpatient care (19.3% versus 16.8%; P<0.05), and fibromyalgia-related outpatient care (62.1% versus 51.8%; P<0.05). From the preinitiation period to the postinitiation period, the duloxetine cohort experienced decreases in certain utilization rates, whereas the pregabalin cohort had increases (percentage of patients with a fibromyalgia-related admission, −1.2% versus 0.4% [P<0.01]; number of fibromyalgia-related outpatient claims, −1.7 versus 4.7 [P<0.01]).
Conclusion
Fibromyalgia patients initiating pregabalin tended to consume more fibromyalgia-related inpatient and outpatient care in the first postinitiation year, whereas fibromyalgia patients initiating duloxetine tended to have lower utilization rates of fibromyalgia-related inpatient care in the postinitiation year than in the preinitiation year.
doi:10.2147/JPR.S51636
PMCID: PMC3891762  PMID: 24470771
fibromyalgia; health care utilization; propensity score methods; duloxetine; pregabalin
12.  Symptoms, the Nature of Fibromyalgia, and Diagnostic and Statistical Manual 5 (DSM-5) Defined Mental Illness in Patients with Rheumatoid Arthritis and Fibromyalgia 
PLoS ONE  2014;9(2):e88740.
Purpose
To describe and evaluate somatic symptoms in patients with rheumatoid arthritis (RA) and fibromyalgia, determine the relation between somatization syndromes and fibromyalgia, and evaluate symptom data in light of the Diagnostic and Statistical Manual-5 (DSM-5) criteria for somatic symptom disorder.
Methods
We administered the Patient Health Questionnaire-15 (PHQ-15), a measure of somatic symptom severity to 6,233 persons with fibromyalgia, RA, and osteoarthritis. PHQ-15 scores of 5, 10, and 15 represent low, medium, and high somatic symptom severity cut-points. A likely somatization syndrome was diagnosed when PHQ-15 score was ≥10. The intensity of fibromyalgia diagnostic symptoms was measured by the polysymptomatic distress (PSD) scale.
Results
26.4% of RA patients and 88.9% with fibromyalgia had PHQ-15 scores ≥10 compared with 9.3% in the general population. With each step-wise increase in PHQ-15 category, more abnormal mental and physical health status scores were observed. RA patients satisfying fibromyalgia criteria increased from 1.2% in the PHQ-15 low category to 88.9% in the high category. The sensitivity and specificity of PHQ-15≥10 for fibromyalgia diagnosis was 80.9% and 80.0% (correctly classified = 80.3%) compared with 84.3% and 93.7% (correctly classified = 91.7%) for the PSD scale. 51.4% of fibromyalgia patients and 14.8% with RA had fatigue, sleep or cognitive problems that were severe, continuous, and life-disturbing; and almost all fibromyalgia patients had severe impairments of function and quality of life.
Conclusions
All patients with fibromyalgia will satisfy the DSM-5 “A” criterion for distressing somatic symptoms, and most would seem to satisfy DSM-5 “B” criterion because symptom impact is life-disturbing or associated with substantial impairment of function and quality of life. But the “B” designation requires special knowledge that symptoms are “disproportionate” or “excessive,” something that is uncertain and controversial. The reliability and validity of DSM-5 criteria in this population is likely to be low.
doi:10.1371/journal.pone.0088740
PMCID: PMC3925165  PMID: 24551146
13.  Objective evidence that small-fiber polyneuropathy underlies some illnesses currently labeled as fibromyalgia 
Pain  2013;154(11):10.1016/j.pain.2013.06.001.
Fibromyalgia is a common, disabling, syndrome that includes chronic widespread pain plus other diverse symptoms. No specific objective abnormalities have been identified, precluding definitive testing, disease-modifying treatments, and identification of causes. In contrast, small-fiber polyneuropathy (SFPN), despite causing similar symptoms, is definitionally a disease caused by dysfunction and degeneration of peripheral small-fiber neurons. SFPN has established etiologies, some diagnosable and definitively treatable, e.g., diabetes. To evaluate the hypothesis that some patients labeled with “fibromyalgia” have unrecognized SFPN causing their illness symptoms, we analyzed SFPN-associated symptoms, signs, and pathological and physiological markers in 27 fibromyalgia patients and 30 matched normal controls. Fibromyalgia subjects had to satisfy American College of Rheumatology criteria plus present documented evidence of a physician’s actual fibromyalgia diagnosis. Study instruments comprised the Michigan Neuropathy Screening Instrument (MNSI), the Utah Early Neuropathy Scale (UENS), distal-leg neurodiagnostic skin biopsies, plus autonomic-function testing (AFT). 41% of skin biopsies from fibromyalgia subjects vs. 3% of biopsies from control subjects were diagnostic for SFPN, and MNSI and UENS scores were higher among fibromyalgia than control subjects (all P ≤ 0.001). Abnormal AFTs were equally prevalent suggesting that fibromyalgia-associated SFPN is primarily somatic. Blood tests from all 13 fibromyalgia subjects with SFPN-diagnostic skin biopsies provided insights into etiologies. All glucose tolerance tests were normal, but eight subjects had dysimmune markers, 2 had hepatitis C serologies, and one family had apparent genetic causality. These findings suggest that some patients with chronic pain labeled as “fibromyalgia” have unrecognized small-fiber polyneuropathy, a distinct disease that can be objectively tested for and sometimes definitively treated.
doi:10.1016/j.pain.2013.06.001
PMCID: PMC3845002  PMID: 23748113
chronic pain; human-subject research; peripheral neuropathy; peripheral nerve; skin biopsy; autonomic function testing
14.  Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial 
Trials  2009;10:24.
Background
Fibromyalgia is a prevalent and disabling disorder characterized by widespread pain and other symptoms such as insomnia, fatigue or depression. Catastrophization is considered a key clinical symptom in fibromyalgia; however, there are no studies on the pharmacological or psychological treatment of catastrophizing. The general aim of this study is to assess the effectiveness of cognitive-behaviour therapy and recommended pharmacological treatment for fibromyalgia (pregabalin, with duloxetine added where there is a comorbid depression), compared with usual treatment at primary care level.
Method/design
Design: A multi-centre, randomized controlled trial involving three groups: the control group, consisting of usual treatment at primary care level, and two intervention groups, one consisting of cognitive-behaviour therapy, and the other consisting of the recommended pharmacological treatment for fibromyalgia.
Setting: 29 primary care health centres in the city of Zaragoza, Spain.
Sample: 180 patients, aged 18–65 years, able to understand and read Spanish, who fulfil criteria for primary fibromyalgia, with no previous psychological treatment, and no pharmacological treatment or their acceptance to discontinue it two weeks before the onset of the study.
Intervention: Psychological treatment is based on the manualized protocol developed by Prof. Escobar et al, from the University of New Jersey, for the treatment of somatoform disorders, which has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy. Pharmacological therapy consists of the recommended pharmacological treatment for fibromyalgia: pregabalin (300–600 mg/day), with duloxetine (60–120 mg/day) added where there is a comorbid depression).
Measurements: The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class. The diagnosis of psychiatric disorders will be made with the Structured Polyvalent Psychiatric Interview. Other instruments to be administered are the Pain Catastrophizing Scale, the Hamilton tests for Anxiety and for Depression, the Fibromyalgia Impact Questionnaire (FIQ), the EuroQuol-5 domains (EQ-5D), and the use of health and social services (CSRI). Assessments will be carried out at baseline, 1, 3, and 6 months.
Main variable: Pain catastrophizing.
Analysis: The analysis will be per intent to treat. We will use the general linear models of the SPSS version 15 statistical package, to analyse the effect of the treatment on the result variable (pain catastrophizing).
Discussion
It is necessary to assess the effectiveness of pharmacological and psychological treatments for pain catastrophizing in fibromyalgia. This randomized clinical trial will determine whether both treatments are effective for this important prognostic variable in patients with fibromyalgia.
Trial registration
Current Controlled Trials ISRCTN10804772
doi:10.1186/1745-6215-10-24
PMCID: PMC2689860  PMID: 19389246
15.  Fibromyalgia: Presentation and management with a focus on pharmacological treatment 
Fibromyalgia is a condition with widespread muscle pain. Prevalence studies showed that 2% to 7% of the population have fibromyalgia, which affects approximately one million Canadians. Fibromyalgia is most common in women, but it also involves men and children. As with most chronic illnesses, the causes of fibromyalgia are unknown. However, recent research supports underlying abnormalities in the central nervous system, which supports fibromyalgia as a chronic disease state and valid clinical entity. Pain is the primary symptom, often accompanied by overwhelming fatigue, sleep dysfunction and cognitive impairment. In 1990, the American College of Rheumatology developed diagnostic criteria for the diagnosis of fibromyalgia. Lifestyle changes, including pacing of activities and aerobic exercise, are very important in managing fibromyalgia symptoms. Emotional and behavioural therapy can also be helpful. Controlled trials of antidepressants, gabapentinoids, tramadol, zopiclone and sodium oxybate have shown effectiveness in fibromyalgia patients. Pregabalin and duloxetine were recently approved in the United States. Effective management of fibromyalgia is complex and requires a multidisciplinary treatment approach. Response and tolerance of different therapeutic interventions vary from patient to patient. Recent advances in the pathophysiology of fibromyalgia offer hope for new and improved therapies in the management of this disabling condition.
PMCID: PMC2799316  PMID: 19225604
Fatigue; Fibromyalgia; Pain; Treatment
16.  Traumatic experiences, major life stressors, and self-reporting a physician-given fibromyalgia diagnosis 
Psychiatry research  2010;177(3):335-341.
The contribution of stress to the pathophysiology of fibromyalgia has been the subject of considerable debate. The primary purpose of the present study was to evaluate the relationship between traumatic and major life stressors and a fibromyalgia diagnosis in a large group of older women and men. Data were from the federally-funded Biopsychosocial Religion and Health Study, and subjects were 10,424 of the 10,988 survey respondents—two-thirds women and one-third men—providing responses to a fibromyalgia question. Average age was 61.0 ± 13.5 years. A physician-given fibromyalgia diagnosis in a subject’s lifetime was reported by 3.7% of the sample, 4.8% of the women and 1.3% of the men. In two multivariable logistic regression models (all respondents and women only, controlling for age, sex, race/ethnicity, and education), two traumatic experience types (sexual and physical assault/abuse) were associated with a fibromyalgia diagnosis. Two other trauma types (life-threatening and emotional abuse/neglect) and major life stress experiences were not. The highest odds ratios in both models were those for sexual assault/abuse followed by physical assault/abuse. The relationship between age and fibromyalgia was curvilinear in both models (odds ratios rising until approximately age 63 and declining thereafter). In the all-subjects model, being a woman increased the odds of a fibromyalgia diagnosis, and in both models, fibromyalgia was associated with being White (versus non-White) and lower education. We recommend that researchers investigate the relationship between stress and fibromyalgia in concert with genetic and biomarker studies.
doi:10.1016/j.psychres.2009.08.017
PMCID: PMC2868959  PMID: 20382432
Fibromyalgia; Trauma; Stress; Sexual abuse; Physical abuse
17.  The lived experience of fibromyalgia in female patients, a phenomenological study 
Background
Fibromyalgia is a chronic syndrome with no cure. A thorough understanding of the illness experience is therefore key in the palliative care of patients with this condition. In search for supportive treatments fibromyalgia patients often attend a chiropractor or other manual therapist. Knowledge of the meaning and reality of living with this condition to the patient could be considered essential to any health care practitioner playing a role in the management. This study aimed to gain a better understanding of the subjective experience of fibromyalgia, focusing on the personal, occupational and social impact of the condition on patients' lives. This included exploring the patients' views about the future.
Methods
This study employed descriptive phenomenology and adopted Husserl's concept of transcendental subjectivity or "bracketing". This qualitative study involved semi-structured interviews and was undertaken to obtain rich data that reflected the essence of the participants' experience. Participants consisted of six female volunteers, diagnosed with fibromyalgia by the University Hospital Gent, Belgium. Data were analysed using a thematic framework.
Results
Fibromyalgia pervaded all aspects of life. Four main themes arose from data analysis, namely; the impact of fibromyalgia on patients' occupational and personal life, the impact on their future and aspects of social interaction. Nearly all participants had stopped working, giving rise to feelings of uselessness and loss of identity. Leisure activities were also greatly affected. Fibromyalgia was said to alter family bonds, some of which were reinforced, others were broken. The diagnosis was seen as a relief, marking an end to a period of uncertainty. Participants reported ambivalence in interaction. Despite some positive encounters, frustration arising from perceived incomprehension dominated. Consequently patients preferred not to share their experiences.
Conclusions
The study revealed the negative impact of fibromyalgia on patients' lives as comprising of great complexity and individuality. Several implications for health care practitioners can be extrapolated, including the need of a more efficient diagnostic process and increased education about the fibromyalgia experience. Further studies are required to better clarify the multifaceted nature of living with the condition.
doi:10.1186/2045-709X-19-22
PMCID: PMC3197545  PMID: 21929763
18.  Correlates of Perceived Pain-Related Restrictions among Women with Fibromyalgia 
Pain medicine (Malden, Mass.)  2010;11(11):1698-1706.
Objective
To identify correlates of perceived pain-related restrictions in a community sample of women with fibromyalgia.
Method
The fibromyalgia group was composed of white women with a self-reported, physician-given fibromyalgia diagnosis (N = 238) from the Biopsychosocial Religion and Health Study (BRHS). BRHS respondents had participated in the larger Adventist Health Study-2. To identify associations with pain-related restrictions, we used hierarchical linear regression. The outcome measure was subjects' pain-related restrictions (one SF-12 version 2 item). Predictors included age, education, body mass index (BMI), sleep apnea, and fibromyalgia treatment in the last year, as well as standardized measures for trauma, major life stress, depression, and hostility. To better interpret the findings, pain-related restrictions also were predicted in women with osteoarthritis and no fibromyalgia.
Results
Women with fibromyalgia reporting the more severe pain-related restrictions were those who had experienced trauma accompanied by physical pain, were older, less educated, more depressed, more hostile, had high BMI scores, and had been treated for fibromyalgia in the last 12 months (adjusted R2 = 0.308). Predictors in women with osteoarthritis were age, BMI, treatment in the last 12 months, experience of a major life stressor, and greater depression symptom severity (adjusted R2 = 0.192).
Conclusions
In both groups, age, BMI, treatment in the last 12 months, and depression predicted pain-related restrictions. Experience of a traumatic event with physical pain was the strongest predictor in the fibromyalgia group. These findings may be useful in constructing novel treatments and prevention strategies for pain-related morbidity in fibromyalgia patients.
doi:10.1111/j.1526-4637.2010.00988.x
PMCID: PMC3539411  PMID: 21044260
Fibromyalgia; Osteoarthritis; Pain; Central Nervous System; Trauma; Stress
19.  A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia 
Arthritis Research & Therapy  2012;14(5):R217.
Introduction
Fibromyalgia is a chronic disorder characterized by widespread pain and tenderness. Prior trials have demonstrated the efficacy of pregabalin for the relief of fibromyalgia symptoms, and it is approved for the treatment of fibromyalgia in the United States. However, prior to this study, there has not been a large-scale efficacy trial in patients with fibromyalgia in Japan.
Methods
This randomized, double-blind, multicenter, placebo-controlled trial was conducted at 44 centers in Japan to assess the efficacy and safety of pregabalin for the symptomatic relief of pain in fibromyalgia patients. Patients aged ≥18 years who had met the criteria for fibromyalgia were randomized to receive either pregabalin, starting at 150 mg/day and increasing to a maintenance dose of 300 or 450 mg/day, or placebo, for 15 weeks. The primary efficacy endpoint was mean pain score at final assessment. Secondary endpoints included Patient Global Impression of Change (PGIC) together with measures of sleep, physical functioning and quality of life.
Results
A total of 498 patients (89% female) were randomized to receive either pregabalin (n = 250) or placebo (n = 248). Pregabalin significantly reduced mean pain score at final assessment (difference in mean change from baseline, compared with placebo -0.44; P = 0.0046) and at every week during the study (P <0.025). Key secondary endpoints were also significantly improved with pregabalin treatment compared with placebo, including PGIC (percentage reporting symptoms "very much improved" or "much improved", 38.6% vs 26.7% with placebo; P = 0.0078); pain visual analog scale (difference in mean change from baseline, compared with placebo -6.19; P = 0.0013); Fibromyalgia Impact Questionnaire total score (-3.33; P = 0.0144); and quality of sleep score (-0.73; P <0.0001). Treatment was generally well tolerated, with somnolence and dizziness the most frequently reported adverse events.
Conclusions
This trial demonstrated that pregabalin, at doses of up to 450 mg/day, was effective for the symptomatic relief of pain in Japanese patients with fibromyalgia. Pregabalin also improved measures of sleep and functioning and was well tolerated. These data indicate that pregabalin is an effective treatment option for the relief of pain and sleep problems in Japanese patients with fibromyalgia.
Trial Registration
ClinicalTrials.gov: NCT00830167
doi:10.1186/ar4056
PMCID: PMC3580529  PMID: 23062189
20.  The Fibromyalgia Family Study: A Genome-Scan Linkage Study 
Arthritis and rheumatism  2013;65(4):1122-1128.
Objective
Familial aggregation of fibromyalgia has been increasingly recognized. The goal of the current study was to conduct a genome wide linkage scan to identify susceptibility loci for fibromyalgia.
Methods
We genotyped members of 116 families from the Fibromyalgia Family Study and performed a model-free genome-wide linkage analysis of fibromyalgia with 341 microsatellite markers, using the Haseman-Elston regression approach.
Results
The estimated sibling recurrence risk ratio (λs) for fibromyalgia was 13.6 (95% CI: 10.0–18.5), based on a reported population prevalence of 2%. Genome-wide suggestive evidence of linkage was found at marker D17S2196 (Empirical P =0.00030) and D17S1294 (Empirical P =0.00035) on chromosome 17p11.2-q11.2.
Conclusion
The estimated sibling recurrence risk ratio suggests a strong genetic component of fibromyalgia. This is the first study to report genome-wide suggestive linkage of fibromyalgia to the chromosome 17p11.2-q11.2 region. Further investigation of these multi-case families from the Fibromyalgia Family Study is warranted to identify potential causal risk variants for fibromyalgia.
doi:10.1002/art.37842
PMCID: PMC3618544  PMID: 23280346
fibromyalgia; genome scan; linkage; sibling pairs; multi-case families
21.  Music as a sleep aid in fibromyalgia 
Fatigue and nonrestorative sleep are some of the most common symptoms associated with fibromyalgia, and are associated with a considerable reduction in quality of life. Certain pharmacological agents that positively affect sleep have been shown to improve fibromyalgia symptoms. Delta-embedded music may help to decrease sleep onset latency and, thus, improve sleep. Accordingly, the authors of this study aimed to elucidate the effects that this type of music has on sleep and fibromyalgia symptoms in a cohort of 20 individuals with fibromyalgia.
BACKGROUND:
Interventions to improve sleep in fibromyalgia may generalize to improvements in multiple symptom domains. Delta-embedded music, pulsating regularly within the 0.25 Hz to 4 Hz frequency band of brain wave activity, has the potential to induce sleep.
OBJECTIVES:
To assess the effects of a delta-embedded music program over four weeks for sleep induction in patients with fibromyalgia.
METHODS:
The present unblinded, investigator-led pilot study used a within-subject design. Analysis was based on 20 individuals with fibromyalgia who completed the study, of the 24 recruited into the study. The primary outcome variables were the change from baseline in Fibromyalgia Impact Questionnaire (FIQ) and Jenkins Sleep Scale scores. A patient global impression of change was measured on a seven-point Likert scale. Secondary outcome measures, comprised of items 5, 6 and 7 of the FIQ, were used as indicators of pain, tiredness and being tired on awakening.
RESULTS:
The FIQ median score of 76.4 (95% CI 61.3 to 82.1) at baseline improved to 60.3 (95% CI 53.1 to 72.0; P=0.004). The Jenkins Sleep Scale median value of 17.5 (95% CI 15.5 to 18.5) at baseline fell to 12.5 (95% CI 8.5 to 14.5; P=0.001) at study completion. The outcomes of the patient global impression of change ratings were mostly positive (P=0.001). Being tired on awakening declined significantly from a median of 9.0 (95% CI 8.0 to 10.0) to 8.0 (95% CI 5.5 to 9.0; P=0.021). However, there was no significant improvement in pain level (baseline median 7.5 [95% CI 7.0 to 8.5] versus study completion median 7.0 [95% CI 6.5 to 8.0]; P=0.335) or tiredness (baseline median 9.0 [95% CI 8.0 to 9.5] versus study completion median 8.0 [95% CI 6.0 to 8.5]; P=0.061). There were no serious adverse events.
CONCLUSIONS:
Delta-embedded music is a potential alternative therapy for fibromyalgia.
PMCID: PMC4028660  PMID: 24555178
Delta embedded music; Fibromyalgia; Sleep disorders
22.  Improving the primary care physicians’ decision making for fibromyalgia in clinical practice: development and validation of the Fibromyalgia Detection (FibroDetect®) screening tool 
Background
Fibromyalgia diagnosis is a challenging and long process, especially among primary care physicians (PCPs), because of symptom heterogeneity, co-morbidities and clinical overlap with other disorders. The purpose was to develop and validate a screening tool in French (FR), German (DE) and English (UK) to help PCPs identify patients with fibromyalgia.
Methods
The FibroDetect questionnaire was simultaneously developed in FR, DE and UK based on information obtained from a literature review, focus groups conducted with clinicians, and face-to-face interviews with fibromyalgia patients (FR, DE and UK, n = 23). The resulting tool was comprehension-tested in patients with diagnosed or suspected fibromyalgia (n = 3 and n = 2 in each country, respectively). Acceptability and applicability were assessed and the tool modified accordingly, then assessed in clinical practice. A scoring method was created using an iterative process based on statistical and clinical considerations with American College of Rheumatology + (ACR+) patients and ACR– patients (n = 276), and validated with fibromyalgia and non-fibromyalgia patients (n = 312).
Results
The FibroDetect included 14 questions assessing patients’ pain and fatigue, personal history and attitudes, symptoms and impact on lives. Six questions were retained in the final scoring, demonstrating satisfactory discriminative power between ACR + and ACR- patients with area under the Receiver Operating Characteristic curve of 0.74. The predictive accuracy of the tool increased to 0.86 for fibromyalgia and non-fibromyalgia patient detection, with a sensitivity of 90% and a specificity of 67% for a cut-off of 6 on the score.
Conclusions
The FibroDetect is a self-administered tool that can be used as a screening classification surrogate to the ACR criteria in primary care settings to help PCPs detect potential fibromyalgia patients among a population complaining of chronic widespread pain.
doi:10.1186/s12955-014-0128-x
PMCID: PMC4221679  PMID: 25341959
Fibromyalgia; Primary health care; Screening tool; Early diagnosis; Decision making; FibroDetect
23.  A link between irritable bowel syndrome and fibromyalgia may be related to findings on lactulose breath testing 
Annals of the Rheumatic Diseases  2004;63(4):450-452.
Objective: To compare the prevalence and test results for bacterial overgrowth between IBS and fibromyalgia.
Methods: Subjects with independent fibromyalgia and IBS were compared with controls in a double blind study. Participants completed a questionnaire, and a lactulose hydrogen breath test was used to determine the presence of SIBO. The prevalence of an abnormal breath test was compared between study participants. Hydrogen production on the breath test was compared between subjects with IBS and fibromyalgia. The somatic pain visual analogue score of subjects with fibromyalgia was compared with their degree of hydrogen production.
Results: 3/15 (20%) controls had an abnormal breath test compared with 93/111 (84%) subjects with IBS (p<0.01) and 42/42 (100%) with fibromyalgia (p<0.0001 v controls, p<0.05 v IBS). Subjects with fibromyalgia had higher hydrogen profiles (p<0.01), peak hydrogen (p<0.0001), and area under the curve (p<0.01) than subjects with IBS. This was not dependent on the higher prevalence of an abnormal breath test. The degree of somatic pain in fibromyalgia correlated significantly with the hydrogen level seen on the breath test (r = 0.42, p<0.01).
Conclusions: An abnormal lactulose breath test is more common in fibromyalgia than IBS. In contrast with IBS, the degree of abnormality on breath test is greater in subjects with fibromyalgia and correlates with somatic pain.
doi:10.1136/ard.2003.011502
PMCID: PMC1754959  PMID: 15020342
24.  Increased absence due to sickness among employees with fibromyalgia 
Background
Little is known about the effect of fibromyalgia on absence due to sickness in working populations.
Objective
To examine the risk of absence due to sickness among employees with fibromyalgia.
Methods
A prospective cohort study with 1‐year follow‐up of recorded and certified absence due to sickness after a survey of chronic diseases among 34 100 Finnish public sector employees (27 360 women and 6740 men) aged 17–65 years at baseline in 2000–2.
Results
20 224 days of absence due to sickness for the 644 employees with fibromyalgia and 454 816 days for others were documented. Of those with fibromyalgia, 67% had co‐occurring chronic conditions such as osteoarthritis, rheumatoid arthritis, depression or other psychiatric disorders. Compared with employees with none of these chronic conditions, the hazard ratio (HR) adjusted for age, sex and occupational status was 1.85‐fold (95% confidence interval (CI) 1.53 to 2.18) for people with fibromyalgia alone and 2.63‐fold (95% CI 2.34 to 2.96) for employees with fibromyalgia with coexisting conditions. The excess rate of absence due to sickness was 61 episodes/100 person‐years among people with fibromyalgia alone. Among employees with musculoskeletal and psychiatric disorders, secondary fibromyalgia was associated with a 1.4–1.5‐fold increase in risk of absence.
Conclusion
Fibromyalgia is associated with a substantially increased risk of medically certified absence due to sickness that is not accounted for by coexisting osteoarthritis, rheumatoid arthritis or psychiatric disorders.
doi:10.1136/ard.2006.053819
PMCID: PMC1798407  PMID: 16793839
25.  Fibromyalgia: From treatment to rehabilitation 
Fibromyalgia is a clinical syndrome of chronic widespread pain and reduced pain thresholds to palpation. The pathophysiology remains unknown, but there is increasing evidence that peripheral and central sensitization cause an amplification of sensory impulses that may alter pain perception in fibromyalgia patients. Interventions to treat fibromyalgia should aim at different targets simultaneously in order to reduce peripheral and central sensitization. There are both pharmacologic and non-pharmacologic approaches with evidence for effectiveness in the treatment of fibromyalgia and its associated symptoms. Evidence from randomized trials and meta-analyses shows that partial and short-term improvements in fibromyalgia symptoms can be achieved with low doses of antidepressants and with physical activity such as aerobic and strengthening exercises. A multidimensional approach which emphasizes education and integration of exercise and cognitive behavior therapy improves quality of life and reduces pain, fatigue and depressive symptoms when measured on a short term basis. More recently, trials have shown the neuromodulators gabapentin and pregabalin to be effective in reducing pain and improving quality of sleep in fibromyalgia. In addition, small trials of noninvasive brain stimulation have also shown benefits in reducing pain in fibromyalgia. It is essential to keep in mind that some important clinical conditions can mimic and overlap with fibromyalgia and should always be ruled out by a complete history, physical examination and appropriate laboratory testing.
doi:10.1016/j.eujps.2009.08.011
PMCID: PMC2907544  PMID: 20657807
Fibromyalgia syndrome; Chronic Pain; Disability; Treatment; Rehabilitation

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