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Psychological therapies for chronic widespread pain and fibromyalgia syndrome
Abstract
Psychological factors such as adverse childhood experiences, traumatic life events, interpersonal conflicts and psychological distress play an important role in the predisposition, onset and severity of chronic widespread pain (CWP) and fibromyalgia syndrome (FMS). Therefore, psychological therapies might have the potential to reduce disability as well as symptom and economic burden in patients with CWP and FMS. Recent interdisciplinary guidelines have suggested different strengths of recommendation for psychological therapies for FMS. The aims of this narrative review are to summarise: • Mechanisms of actions. • Evidence on efficacy, tolerability and safety. • Knowledge gaps and needs for future research of psychological therapies for CWP and FMS for non-mental health professionals.
... Many underlying causes of premature death stem from high risk behaviors involving legal and illicit drug use, dietary choices, sexual promiscuity, and unsafe use of motor vehicles and firearms [27,108]. Conditions common among people who also report ACEs, include chronic pain [33,81,109], headache [110] and fibromyalgia [34,35,111,112], which are problems frequently encountered by chiropractors [113]. Logically, it makes sense that chiropractors who understand ACEs and other traumatic experiences may better recognize affected patients. ...
... Patients with chronic pain disorders, including fibromyalgia, are often seen in chiropractic offices, and the condition has been associated with psychosocial causes, improving with psychological therapies. [80,111,112] In this example, identifying ACEs in connection with fibromyalgia would indicate a referral to a psychological professional. Increasing awareness of ACEs and TIC in chiropractic education and practice is a first step in addressing these public health and safety concerns within the chiropractic profession. ...
Background
Trauma is an emotional response to distressing events where coping and subsequent recovery are absent. Adverse Childhood Experiences (ACEs) are traumas, occurring before the age of 18 years, such as child abuse or neglect, caregiver instability, and household dysfunction. Sixty-four percent of the U.S. population report experiencing at least one ACE, with over 1 billion children experiencing abuse and neglect annually worldwide. Chronic exposure to stressful circumstances or multiple traumatic events has negative physiologic impacts. Persons who experience 3 or more ACEs in childhood are at greater risk of poor mental health outcomes and may be more likely to engage in high-risk behaviors, predisposing them to long-term health impacts, such as metabolic diseases, anxiety, depression, substance use, and chronic pain. Trauma informed care (TIC) is a recommended approach to healthcare delivery across professions, especially when a trauma history is suspected. This commentary aims to increase awareness of the impact of ACEs on health outcomes and introduce TIC concepts as they may apply to chiropractic care for adults with a history of ACEs.
Discussion
This commentary reviews an introductory model (4R's: realize, recognize, respond, resist re-traumatization) as one TIC framework used by healthcare practitioners. Prior trauma can lessen trust, alter perceptions of physical touch, and hands-on examinations and chiropractic treatments may trigger stress responses. Using TIC after appropriate training, includes referrals to multidisciplinary providers to address trauma-related concerns outside the scope of chiropractic, and screening for ACEs if deemed appropriate. Creating safe spaces, communicating clearly, avoiding victimizing language, explaining procedures, asking for consent before physical contact, and giving patients choice and control in their own care may avoid triggering prior traumas.
Conclusion
Given the high worldwide prevalence of persons experiencing 3 or more ACEs, TIC principles are practical adaptations to chiropractic care for use with many patient populations. As TIC and ACEs are emerging concepts within chiropractic, students and practitioners are encouraged to undertake additional training to better understand these complex and sensitive topics. Exploratory research on the incidence, presentation, and impacts of various trauma types, including ACEs, to support adoption of TIC in chiropractic settings is essential.
... Patient education combined with exercise is recommended for the treatment of FM [7,23]. One method of learning, known as cognitive behavioral therapy, consists of two elements: (a) behavioral, which is based on the theories of classical and operant conditioning and is focused on aspects of the environment that modulate pain and other symptoms, and (b) cognitive, which is based on Beck's cognitive model of depression, in which the way individuals structure the world influences their pain, other symptoms, functionality, and emotions. ...
Abstract Background Muscle stretching exercises preserve corporal flexibility and decrease the retraction and shortening of myofascial and articular structures. These exercises are recommended for the treatment of fibromyalgia (FM). The purpose of the study was to verify and compare the effect of muscle stretching exercises on FM patients based on the global posture reeducation method against segmental muscle stretching exercises, both used in concert with an educational approach rooted in cognitive behavioral therapy. Methods Forty adults with FM were randomly allocated into two groups: global and segmental. The two kinds of therapies were performed in 10 individual sessions once a week. Two assessments were made: one at baseline and one at the end of therapy. The primary outcome variable was pain intensity (Visual Analog Scale). The secondary outcome variables were multidimensional pain (McGill Pain Questionnaire), the pain threshold at tender points (dolorimetry), attitudes toward chronic pain (Survey of Pain Attitudes-Brief Version), body posture (Postural Assessment Software Protocol), postural control (Modified Clinical Test of Sensory Interaction on Balance), flexibility (sit-and-reach test), the impact of FM on quality of life (Fibromyalgia Impact Questionnaire, FIQ), and self-reported perceptions and body self-care. Results At the end of treatment, there were no statistically significant differences between the groups in the outcome variables. Furthermore, the groups presented lower pain intensity (baseline vs. final; global group: 6 ± 1.8 vs. 2.2 ± 1.6 cm, p
... To summarize the results of these meta-analyses, it appears that almost any type of trauma or stressful life event can contribute to the development of FMS. In the next sections, we put the focus on reliable, valid, and useful psychological instruments for patients with FMS [27] and on some empirically validated psychological therapies for this syndrome [28]. ...
Purpose of review: This review focuses on the role of psychologists in the assessment and treatment of fibromyalgia syndrome (FMS), a highly prevalent condition characterized by chronic widespread pain, fatigue, cognitive problems, distress, and disability.
Recent findings: A large body of work supports the effectiveness and cost-utility of psychological therapies for the improvement of a wide range of symptoms associated with FMS. However, patients with FMS are best assessed and treated by a multidisciplinary team, in which psychologists have an important role. Multidisciplinary treatment, in which each healthcare professional offers his or her own expertise to the patient, has been shown to produce more ubiquitous treatment effects for this complex syndrome than single discipline treatments. Considering the empirical evidence and documented experience of patients, people with FMS can benefit from integrated care, combining education, exercise, and psychotherapeutic approaches, including cognitive-behavioral therapy.
Summary: There has been a call for more health economics research to demonstrate the cost-effectiveness of psychological therapies. In this paper, we highlight the added value of psychologists as members of multidisciplinary treatment teams, who can assess and treat the maladaptive cognitive, emotional, and behavioral symptoms that are commonly seen in individuals with FMS.
... However, close monitoring and treatment of psychological trauma are also indicated across the lifespan of FM patients. Tis should encourage clinicians to assess psychological trauma routinely and to include trauma-focused therapies within established multidisciplinary health care professionals, following existing FM guidelines [96]. Future research lines should test the trauma-focused intervention in FM and could also clarify the trauma-based etiology of FM in comparison to other FSSs, medically unexplained symptoms, somatic symptoms, and related disorders following the DSM-5. ...
Background:
Preliminary evidence suggests that psychological trauma, especially childhood trauma, is a risk factor for the onset of fibromyalgia (FM).
Objective:
The main objective of this study consisted of evaluating the prevalence and detailed characteristics of psychological trauma in a sample of patients with FM, the chronology of trauma across the lifespan, and its clinical symptoms. We also calculated whether childhood trauma could predict the relationship with different clinical variables.
Method:
Eighty-eight females underwent an interview to assess sociodemographic data, psychiatric comorbidities, level of pain, FM impact, clinical symptoms of anxiety, depression, insomnia, quality of life, and psychological trauma.
Results:
The majority of participants (71.5%) met the diagnostic criteria for current post-traumatic stress disorder (PTSD). Participants reported having suffered traumatic events throughout their lifespan, especially in childhood and early adolescence, in the form of emotional abuse, emotional neglect, sexual abuse, and physical abuse. Traumatic events predict both poor quality of life and a level of pain in adulthood. All patients showed clinically relevant levels of anxiety, depression, insomnia, suicidal thoughts, and pain, as well as somatic comorbidities and poor quality of life. Pain levels predicted anxiety, depression, dissociation, and insomnia symptoms. 84% of the sample suffered one or more traumatic events prior to the onset of pain.
Conclusions:
Our data highlight the clinical complexity of patients with FM and the role of childhood trauma in the onset and maintenance of FM, as well as the high comorbidity between anxiety, depression, somatic symptoms, and FM. Our data also supports FM patients experiencing further retraumatization as they age, with an extremely high prevalence of current PTSD in our sample. These findings underscore the need for multidisciplinary programs for FM patients to address their physical pain and their psychiatric and somatic conditions, pay special attention to the assessment of psychological trauma, and provide trauma-focused interventions. Trial registration: ClinicalTrials.gov NCT04476316. Registered on July 20th, 2020.
... Given diverse FM manifestations ranging from dominant localized pain to diffuse body pain, and the varied phenotypes arise from diverse biologic mechanisms, including central, peripheral, and mixed endotypes, there is a rationale to tailor appropriate management according to individual patient characteristics [30,31]. In the central endotype, early non-pharmacological interventions such as psychotherapy, physical reconditioning, and modification of social-driven factors are more promising [71,72]. On the contrary, control of peripheral offenders such as nociceptive stimuli and inflammation is a prime concern in the peripheral endotype of FM [11,73]. ...
Nociplastic pain (NP), as a mechanistic term, denotes pain arising from altered nociception without clear evidence of tissue or somatosensory damage. Fibromyalgia (FM), a prototypical NP condition, incorporates a broad continuum of phenotypes with a distinct neurobiological signature and shared NP attributes. The nociplastic concept may provide a new opportunity for early diagnosis of FM by identifying the characteristic NP features before a state of pain generalization and symptoms clustering. In this approach, even individual symptoms associated with NP features are worthy of attention to denote FM. It may provide a timely diagnosis of FM before clinical progression to a severe and hard-to-manage condition. Furthermore, collecting all various FM phenotypes under the nociplastic concept and not delimiting FM to the only typical presentation allows investigators to identify FM subgroups reflecting potentially distinct pathophysiologic mechanisms and biomarkers. This viewpoint can be served in future studies to develop individualized management. In this review, we postulate a novel approach to early FM diagnosis and management based on NP conceptualization and phenotype recognition.
Key Points
• FM as a NP condition represents overlapping clinical phenotypes and incomplete presentations especially in early stage of illness.
• The mechanistic approach based on the NP features of FM can be implicated in the timely diagnosis and management of FM.
• The NP-based approach to FM provides a broader viewpoint beyond FM delimitation to pain generalization and polysymptomatic complaints.
... Н е м е д и к а м е н т о з н ы е м е т о д ы л е ч е н и я ф и б р о м и а л г и и Психологические методы представляют одно из ведущих направлений терапии при ФМ [46]. EULAR предлагает использовать когнитивно-поведенческую терапию (КПТ), терапию снижения стресса на основе осознанности (Mindfulness-Based Stress Reduction, MBSR), иглорефлексотерапию и не рекомендует биологическую обратную связь (БОС) и гипнотерапию [7]. ...
Fibromyalgia (FM) occurs in 5–12% of patients but is relatively rarely diagnosed, so most patients do not receive adequate treatment. The review analyses pharmacological and non-pharmacological methods of FM treatment. Data suggests that antidepressants (duloxetine, milnacipran, amitriptyline) and antiepileptics (pregabalin, gabapentin) are most effective. Among non-pharmacological methods, the effectiveness of cognitive-behavioral and mindfulness therapy, kinesiotherapy, and biofeedback has been shown. In the management of patients with FM, a combination of non-pharmacological methods and medications can reduce pain and improve the quality of life.
... CWP is the defining feature of fibromyalgia, where widespread pain is accompanied by fatigue, waking unrefreshed and cognitive symptoms [3]. Fibromyalgia has a reported global prevalence of 2.7% [4] and is increasingly viewed as representing the severe end of a CWP spectrum [2,5,6]. Guidelines for the management of CWP including fibromyalgia recommend non-pharmacological interventions as first-line care [6][7][8], with a limited number of pharmacotherapies used to manage severe symptoms [e.g. ...
Background
Chronic widespread pain (CWP) including fibromyalgia has a prevalence of up to 15% and is associated with substantial morbidity. Supporting psychosocial and behavioural self-management is increasingly important for CWP, as pharmacological interventions show limited benefit. We systematically reviewed the effectiveness of interventions applying self-management principles for CWP including fibromyalgia.
Methods
MEDLINE, Embase, PsycINFO, The Cochrane Central Register of Controlled Trials and the WHO International Clinical Trials Registry were searched for studies reporting randomised controlled trials of interventions adhering to self-management principles for CWP including fibromyalgia. Primary outcomes included physical function and pain intensity. Where data were sufficient, meta-analysis was conducted using a random effects model. Studies were narratively reviewed where meta-analysis could not be conducted Evidence quality was rated using GRADE (Grading of Recommendations, Assessment, Development and Evaluations) (PROSPERO-CRD42018099212).
Results
Thirty-nine completed studies were included. Despite some variability in studies narratively reviewed, in studies meta-analysed self-management interventions improved physical function in the short-term, post-treatment to 3 months (SMD 0.42, 95% CI 0.20, 0.64) and long-term, post 6 months (SMD 0.36, 95% CI 0.20, 0.53), compared to no treatment/usual care controls. Studies reporting on pain narratively had greater variability, however, those studies meta-analysed showed self-management interventions reduced pain in the short-term (SMD -0.49, 95% CI -0.70, -0.27) and long-term (SMD -0.38, 95% CI -0.58, -0.19) compared to no treatment/usual care. There were few differences in physical function and pain when self-management interventions were compared to active interventions. The quality of the evidence was rated as low.
Conclusion
Reviewed studies suggest self-management interventions can be effective in improving physical function and reducing pain in the short and long-term for CWP including fibromyalgia. However, the quality of evidence was low. Future research should address quality issues whilst making greater use of theory and patient involvement to understand reported variability.
... Based on the Pain Catastrophizing Scale score, 46% of our cohort has a high risk of developing persistence of their pain and disability (PSC > 30) (18). This supports the importance of applying a psychosomatic approach for clinical management of chronic pain in endometriosis patients (61). Follow-up studies to assess the impact of race, ethnicity, and socioeconomic factors on the pain catastrophizing scores in this patient population are warranted. ...
Background: An international collaborative study was conducted to determine the demographic and clinical profiles of Hispanic/Latinx endometriosis patients from Latin America and Spain using the Minimal Clinical Questionnaire developed by the World Endometriosis Research Foundation (WERF) Endometriosis Phenome and Biobanking Harmonization Project (EPHect).
Methods: This is a cross-sectional study to collect self-reported data on demographics, lifestyle, and endometriosis symptoms of Hispanic/Latinx endometriosis patients from April 2019 to February 2020. The EPHect Minimal Clinical Questionnaire (EPQ-M) was translated into Spanish. Comprehension and length of the translated survey were assessed by Spanish-speaking women. An electronic link was distributed via social media of endometriosis patient associations from 11 Latin American countries and Spain. Descriptive statistics (frequency, means and SD, percentages, and proportions) and correlations were conducted using SPSSv26.
Results: The questionnaire was completed by 1,378 participants from 23 countries; 94.6% had self-reported diagnosis of endometriosis. Diagnostic delay was 6.6 years. Most participants had higher education, private health insurance, and were employed. The most common symptoms were back/leg pain (85.4%) and fatigue (80.7%). The mean number of children was 1.5; 34.4% had miscarriages; the mean length of infertility was 3.7 years; 47.2% reported pregnancy complications. The most common hormone treatment was oral contraceptives (47.0%). The most common comorbidities were migraines (24.1%), polycystic ovary syndrome (PCOS) (22.2%), and irritable bowel syndrome (21.1%). Most participants (97.0%) experienced pelvic pain during menses; for 78.7%, pain was severe; 86.4% reported dyspareunia. The mean age of dysmenorrhea onset was 16.2 years (SD ± 6.1). Hormone treatments were underutilized, while impact was substantial. Pain catastrophizing scores were significantly correlated with pain intensity ( p < 0.001).
Conclusion: This is the first comprehensive effort to generate a clinical–demographic profile of Hispanic/Latinx endometriosis patients. Differences in clinical presentation compared to other cohorts included higher prevalence and severity of dysmenorrhea and dyspareunia and high levels of pain catastrophizing. Though future studies are needed to dissect the impact of race and ethnicity on pain and impact, this profile is the first step to facilitate the recognition of risk factors and diagnostic features and promote improved clinical management of this patient population. The EPHect questionnaire is an efficient tool to capture data to allow comparisons across ethnicities and geographic regions and tackle disparities in endometriosis research.
... From the field of psychology, researchers and professionals have worked intensively on the design, implementation, and testing of psychotherapeutic interventions in patients with FS [16]. Diverse psychological interventions have shown favorable results, from cognitive behavioral approaches [17,18] to psychoeducational [19] and mind and body therapies [20]. ...
Objective:
To provide a brief and comprehensive summary of the recent evidence from clinical trials testing psychotherapeutic interventions in patients with fibromyalgia with particular interest in their possible effect on physical pain.
Methods:
Bibliographical search was performed in PubMed, PsycInfo, Web of Science, Scopus, and Cochrane Library databases. Content of the manuscripts was studied to obtain, if available, the following information: year of publication, location of the research team, design, type of psychotherapeutic intervention tested, pain measures, and a brief description of the psychotherapy, groups, and outcomes regarding physical pain.
Results:
Initial search eliciting 475 citations got reduced to 13 relevant papers. Most research studies from Spain (n = 8) are randomized control trials (n = 10) and used guided imagery (n = 5) or cognitive behavioral therapy (n = 4). The Visual Analogue Scale (n = 4) and the Fibromyalgia Impact Questionnaire (n = 4) were the physical pain measures mostly used. Improvements on physical pain were reported on all studies with published results; nevertheless, only in five cases, differences were significant.
Conclusions:
Evidence on the effect of psychotherapy on physical pain in patients with FS was divergent; though most studies report a reduction in pain, this was not always lasting and/or significant. Diversity of the results might be due to the selected psychotherapeutic approaches, assessment tools, and other internal (e.g., personality traits, (sub)clinical psychiatric symptoms, and treatment adherence) and external (e.g., family environment and social support) variables worth to be considered in the future research.
... Based on the Pain Catastrophizing Scale score, 46% of our cohort has a high risk of developing persistence of their pain and disability (PSC > 30) (18). This supports the importance of applying a psychosomatic approach for clinical management of chronic pain in endometriosis patients (61). Follow-up studies to assess the impact of race, ethnicity, and socioeconomic factors on the pain catastrophizing scores in this patient population are warranted. ...
INTRODUCTION
This study was conducted to determine for the first time the demographic and clinical profile of women with endometriosis of Hispanic/Latina background, a patient population not well represented in databases and cohort studies. In order to gather standardized, comparable data we used the Clinical Questionnaire developed by the Endometriosis Phenome project (EPhect) of the World Endometriosis Research Foundation (WERF).
METHODS
A cross-sectional anonymous study was conducted using the Spanish translation of the questionnaire. A REDCap-based link was distributed via social media to women with endometriosis in collaboration with Patient Associations. Data was analyzed using SPSS.
RESULTS
Women (1,296) from 22 countries of South America, Central America, the Caribbean, Spain and US participated. Patients reported on education (43.5% had a degree), race (49.8% were white), and work (78.5%). Mean age was 33.7 years old (y/o; range 15–66); at menarche was 12 y/o; at pain onset was 16.2 y/o. Many reported having regular menstrual cycles (70.4%), and profuse menstrual bleeding (47.9%). Most (78.9%) patients reported severe pelvic pain (mean VAS 7.7). Most (82.9%) reported dyspareunia (mean VAS 6.3). Mean number of children was 1.52; 40.3% reported infertility/abortion; only 27.6% sought infertility treatment. The mean length of infertility was 0.52 years (range 0.08–8 years). Quality of life was negatively impacted in household chores (64.8%), sleep (58.7%), and exercise/sports (56.4%).
CONCLUSION
Hispanic/Latina women with endometriosis present with severe symptoms and substantial quality of life impact. The EPhect questionnaire is a valuable tool to capture data and allow comparisons across ethnicities and geographic regions.
Objetivo: evaluar el efecto de intervenciones grupales multidisciplinarias por equipo de atención primaria de salud, guiadas por médico de familia sobre los síntomas, calidad de vida y dinámica familiar de pacientes con fibromialgia. Metodología: estudio longitudinal comparativo. Las participantes fueron 20 pacientes adultas diagnosticadas clínicamente con fibromialgia pertenecientes al CESFAM de la comuna de Pelarco, región del Maule, Chile. El protocolo de actividades se basó en talleres semanales con equipo multidisciplinario integrado por kinesiólogo, nutricionista, psicólogo y médico de familia. Resultados: el abordaje multidisciplinar mejoró significativamente los indicadores de calidad de vida y dinámica familiar a su vez que disminuyeron significativamente los síntomas clínicos de dichos pacientes (p<0.05). Conclusión: las pacientes con diagnóstico de fibromialgia tuvieron mejorías significativas en su cuadro clínico mediante un abordaje multidisciplinar de su condición funcional.
Introduction:
Fibromyalgia (FM) is a chronic pain syndrome associated with fatigue, insomnia, dyscognition, and emotional distress. Critical illness mechanisms include central sensitization to nociceptive and non-nociceptive stimuli often resulting in hypersensitivity to all sensory input.
Areas covered:
The clinical presentation of FM can vary widely and therefore requires therapies tailored to each patient's set of symptoms. This manuscript examines currently prescribed therapeutic approaches supported by empirical evidence as well as promising novel treatments. Although pharmacological therapy until now has been only moderately effective for FM symptoms, it represents a critical component of every treatment plan.
Expert opinion:
Currently approved pharmacological therapies for FM symptoms have limited but proven effectiveness. Novel therapies with cannabinoids and naltrexone appear promising. Recent functional imaging studies of FM have discovered multiple brain network abnormalities that may provide novel targets for mechanism-based therapies. Future treatment approaches, however, need to improve more than clinical pain but also other FM domains like fatigue, insomnia, and distress.
Psychiatric comorbidity is common in patients with fibromyalgia. It is critical that such conditions are identified and addressed, as to fail to take a patient’s mental health into consideration is one way to assure suboptimal pain and functional outcomes. In this chapter, the most common mental health conditions will be discussed including mood disorders such as depression and bipolar disorder, a range of anxiety disorders, substance use disorders, somatic symptoms disorders, and the prospect of suicidality. Yet, we also discuss an often-overlooked aspect of mental health in people with FM, positive emotions and resilience. Some of the patients you will encounter have good, even great, mental health with high levels of grit, gratitude, and/or positive affect (happiness). These patients are those who will be more likely to do well with treatment and everyday life, despite the pain. Also, we will touch on the psychosocial and neurobiological aspects of mood and anxiety disorders in the context of chronic pain where shared mechanisms are presumed to be at play. Lastly, some practical recommendations about the approach to caring for these patients are made.
Fibromyalgia and other chronic musculoskeletal pain syndromes are associated with stressful early life events, which can produce a persistent dysregulation in the hypothalamic-pituitary adrenal (HPA) stress axis function, associated with elevated plasm levels of corticosterone in adults. To determine the contribution of the HPA axis to persistent muscle hyperalgesia in adult rats that had experienced neonatal limited bedding (NLB), a form of early-life stress, we evaluated the role of glucocorticoid receptors on muscle nociceptors in adult NLB rats. In adult male and female NLB rats, mechanical nociceptive threshold in skeletal muscle was significantly lower than in adult control (neonatal standard bedding) rats. Furthermore, adult males and females that received exogenous corticosterone (via dams' milk) during postnatal days 2-9, displayed a similar lowered mechanical nociceptive threshold. To test the hypothesis that persistent glucocorticoid receptor signaling in the adult contributes to muscle hyperalgesia in NLB rats, nociceptor expression of glucocorticoid receptor (GR) was attenuated by spinal intrathecal administration of an oligodeoxynucleotide (ODN) antisense to GR mRNA. In adult NLB rats, GR antisense markedly attenuated muscle hyperalgesia in males, but not in females. These findings indicate that increased corticosterone levels during a critical developmental period (postnatal days 2-9) produced by NLB stress induces chronic mechanical hyperalgesia in male and female rats that persists in adulthood, and that this chronic muscle hyperalgesia is mediated, at least in part, by persistent stimulation of glucocorticoid receptors on sensory neurons, in the adult male, but not female rat.
Background and Objective
This systematic review aimed at evaluating the efficacy, acceptability and safety of internet‐based psychological therapies (IPTs) in fibromyalgia syndrome (FMS).
Databases and Data Treatment
Cochrane Library, MEDLINE, PsycINFO and SCOPUS were searched from inception to January 2018. Randomized controlled trials (RCTs) comparing IPTs with controls were analysed. Primary outcomes were ≥ 50% pain relief, disability, negative mood, acceptability and safety at end of therapy and at six months follow up. Effects were summarized by a random effects model using risk differences (RD) or standardized mean differences (SMD) with 95% confidence intervals (CI). Six RCTs using different types of internet‐based cognitive‐behavioral therapies [ICBTs] (acceptance‐based; exposure‐based; traditional) with 493 patients were included. At the end of treatment, ICBTs were superior to controls (waiting list, attention control, treatment as usual) in reducing negative mood (SMD ‐0.51 [95% CI ‐0.87 to ‐0.15]) (moderate quality evidence) and disability (SMD ‐0.56 [95% CI ‐1.00 to ‐0.13]) (moderate quality evidence). There were no statistically significant differences between ICBTs and controls in pain relief of 50% or greater (RD 0.09 [95% CI ‐0.02 to 0.20] (moderate quality) and acceptability (moderate quality evidence). No data on safety and any outcomes at long‐term follow up compared to controls were found. The data available did not allow statistical comparisons between unguided and guided ICBTs and of ICBTs vs. traditional face‐to‐face therapies.
Conclusions
ICBTs provided a clinically relevant benefit over control interventions in reducing negative mood and disability at the end of treatment.
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Background:
Fibromyalgia is a clinically defined chronic condition of unknown etiology characterized by chronic widespread pain that often co-exists with sleep disturbances, cognitive dysfunction and fatigue. People with fibromyalgia often report high disability levels and poor quality of life. Drug therapy, for example, with serotonin and noradrenaline reuptake inhibitors (SNRIs), focuses on reducing key symptoms and improving quality of life. This review updates and extends the 2013 version of this systematic review.
Objectives:
To assess the efficacy, tolerability and safety of serotonin and noradrenaline reuptake inhibitors (SNRIs) compared with placebo or other active drug(s) in the treatment of fibromyalgia in adults.
Search methods:
For this update we searched CENTRAL, MEDLINE, Embase, the US National Institutes of Health and the World Health Organization (WHO) International Clinical Trials Registry Platform for published and ongoing trials and examined the reference lists of reviewed articles, to 8 August 2017.
Selection criteria:
We selected randomized, controlled trials of any formulation of SNRIs against placebo or any other active treatment of fibromyalgia in adults.
Data collection and analysis:
Three review authors independently extracted data, examined study quality, and assessed risk of bias. For efficacy, we calculated the number needed to treat for an additional beneficial outcome (NNTB) for pain relief of 50% or greater and of 30% or greater, patient's global impression to be much or very much improved, dropout rates due to lack of efficacy, and the standardized mean differences (SMD) for fatigue, sleep problems, health-related quality of life, mean pain intensity, depression, anxiety, disability, sexual function, cognitive disturbances and tenderness. For tolerability we calculated number needed to treat for an additional harmful outcome (NNTH) for withdrawals due to adverse events and for nausea, insomnia and somnolence as specific adverse events. For safety we calculated NNTH for serious adverse events. We undertook meta-analysis using a random-effects model. We assessed the evidence using GRADE and created a 'Summary of findings' table.
Main results:
We added eight new studies with 1979 participants for a total of 18 included studies with 7903 participants. Seven studies investigated duloxetine and nine studies investigated milnacipran against placebo. One study compared desvenlafaxine with placebo and pregabalin. One study compared duloxetine with L-carnitine. The majority of studies were at unclear or high risk of bias in three to five domains.The quality of evidence of all comparisons of desvenlafaxine, duloxetine and milnacipran versus placebo in studies with a parallel design was low due to concerns about publication bias and indirectness, and very low for serious adverse events due to concerns about publication bias, imprecision and indirectness. The quality of evidence of all comparisons of duloxetine and desvenlafaxine with other active drugs was very low due to concerns about publication bias, imprecision and indirectness.Duloxetine and milnacipran had no clinically relevant benefit over placebo for pain relief of 50% or greater: 1274 of 4104 (31%) on duloxetine and milnacipran reported pain relief of 50% or greater compared to 591 of 2814 (21%) participants on placebo (risk difference (RD) 0.09, 95% confidence interval (CI) 0.07 to 0.11; NNTB 11, 95% CI 9 to 14). Duloxetine and milnacipran had a clinically relevant benefit over placebo in patient's global impression to be much or very much improved: 888 of 1710 (52%) on duloxetine and milnacipran (RD 0.19, 95% CI 0.12 to 0.26; NNTB 5, 95% CI 4 to 8) reported to be much or very much improved compared to 354 of 1208 (29%) of participants on placebo. Duloxetine and milnacipran had a clinically relevant benefit compared to placebo for pain relief of 30% or greater. RD was 0.10; 95% CI 0.08 to 0.12; NNTB 10, 95% CI 8 to 12. Duloxetine and milnacipran had no clinically relevant benefit for fatigue (SMD -0.13, 95% CI -0.18 to -0.08; NNTB 18, 95% CI 12 to 29), compared to placebo. There were no differences between either duloxetine or milnacipran and placebo in reducing sleep problems (SMD -0.07; 95 % CI -0.15 to 0.01). Duloxetine and milnacipran had no clinically relevant benefit compared to placebo in improving health-related quality of life (SMD -0.20, 95% CI -0.25 to -0.15; NNTB 11, 95% CI 8 to 14).There were 794 of 4166 (19%) participants on SNRIs who dropped out due to adverse events compared to 292 of 2863 (10%) of participants on placebo (RD 0.07, 95% CI 0.04 to 0.10; NNTH 14, 95% CI 10 to 25). There was no difference in serious adverse events between either duloxetine, milnacipran or desvenlafaxine and placebo (RD -0.00, 95% CI -0.01 to 0.00).There was no difference between desvenlafaxine and placebo in efficacy, tolerability and safety in one small trial.There was no difference between duloxetine and desvenlafaxine in efficacy, tolerability and safety in two trials with active comparators (L-carnitine, pregabalin).
Authors' conclusions:
The update did not change the major findings of the previous review. Based on low- to very low-quality evidence, the SNRIs duloxetine and milnacipran provided no clinically relevant benefit over placebo in the frequency of pain relief of 50% or greater, but for patient's global impression to be much or very much improved and in the frequency of pain relief of 30% or greater there was a clinically relevant benefit. The SNRIs duloxetine and milnacipran provided no clinically relevant benefit over placebo in improving health-related quality of life and in reducing fatigue. Duloxetine and milnacipran did not significantly differ from placebo in reducing sleep problems. The dropout rates due to adverse events were higher for duloxetine and milnacipran than for placebo. On average, the potential benefits of duloxetine and milnacipran in fibromyalgia were outweighed by their potential harms. However, a minority of people with fibromyalgia might experience substantial symptom relief without clinically relevant adverse events with duloxetine or milnacipran.We did not find placebo-controlled studies with other SNRIs than desvenlafaxine, duloxetine and milnacipran.
Significance:
This updated systematic review with meta-analysis on cognitive behavioural therapies (CBTs) including acceptance-based CBTs endorse the efficacy and tolerability of CBTs in reducing key symptoms and disability in FMS in the short- and long-term if compared to waiting list, treatment as usual, attention controls and active non-pharmacological therapies. CBTs did not differ in efficacy except superiority for coping with pain and tolerability from recommended drug therapy (pregabalin and/or duloxetine).
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.
Chronic widespread pain (CWP) is a significant burden in communities. Understanding the impact of population-dependent (e.g., age, gender) and contextual-dependent (e.g. survey method, region, inequality level) factors have on CWP prevalence may provide a foundation for population-based strategies to address CWP. Therefore, the purpose of this study was to estimate the global prevalence of CWP and evaluate the population and contextual factors associated with CWP. A systematic review of CWP prevalence studies (1990-2017) in the general population was undertaken. Meta-analyses were conducted to determine CWP prevalence, and study population data and contextual factors were evaluated using a meta-regression. Thirty-nine manuscripts met the inclusion criteria. Study CWP prevalence ranged from 1.4% to 24.0%, with CWP prevalence in men ranging from 0.8% to 15.3% and 1.7% to 22.1% in women. Estimated overall CWP prevalence was 9.6% (8.0-11.2%). Meta-regression analyses showed gender, United Nations country development status, and human development index (HDI) influenced CWP prevalence, while survey method, region, methodological and reporting quality, and inequality showed no significant effect on the CWP estimate. Globally CWP affects one in ten individuals within the general population, with women more likely to experience CWP than men. HDI was noted to be the socioeconomic factor related to CWP prevalence, with those in more developed countries having a lower CWP prevalence than those in less developed countries. Most CWP estimates were from developed countries, and CWP estimates from countries with a lower socioeconomic position is needed to further refine the global estimate of CWP.
Significance:
This systematic review and meta-analysis updates the current global CWP prevalence by examining the population-level (e.g. age, gender) and contextual (e.g. country development status; survey style; reporting and methodologic quality) factors associated with CWP prevalence. This analyses provides evidence to support higher levels of CWP in countries with a lower socioeconomic position relative to countries with a higher socioeconomic position.
Patients with FM experience increased lifetime levels of psychosocial adversity, trauma, and emotional conflict. To address these risk factors, we developed Emotion Awareness and Expression Therapy (EAET) and tested its benefits against an active control condition, FM Education, and against the field's gold standard intervention for FM, cognitive-behavioral therapy (CBT) for symptom management. Adults with FM (n = 230) formed 40 treatment groups, which were randomized to EAET, CBT, or Education and given eight, 90-min sessions. Patient-reported outcomes were assessed at baseline, post-treatment, and 6-month follow-up (primary endpoint). Retention of patients to follow-up was excellent (90.4%). Intent-to-treat analyses indicated that, although EAET did not differ from FM Education on pain severity (primary outcome), EAET had significantly better outcomes than FM Education on overall symptoms, widespread pain, physical functioning, cognitive dysfunction, anxiety, depression, positive affect, and life satisfaction (between-condition d's ranging from 0.29 to 0.45 SD), and the percentage of patients improving "much/very much" (34.8% vs. 15.4%). EAET did not differ from CBT on the primary or most secondary outcomes, but compared to CBT, EAET led to significantly lower FM symptoms (d = 0.35) and widespread pain (d = 0.37), and a higher percentage of patients achieving 50% pain reduction (22.5% vs. 8.3%). In summary, an intervention targeting emotional awareness and expression related to psychosocial adversity and conflict was well-received, more effective than a basic educational intervention, and had some advantages over CBT on pain. We conclude that EAET should be considered as an additional treatment option for FM.
Background:
The regular update of the guidelines on fibromyalgia syndrome, AWMF number 145/004, was scheduled 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. A systematic search of the literature for systematic reviews of randomized, controlled studies on psychological and psychotherapeutic procedures 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 available therapies 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.
Results and conclusion:
Cognitive behavioral therapies received a strong recommendation but biofeedback, guided imagery and hypnosis received a weak recommendation.
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. A systematic search of the literature from December 2010 to May 2016 was performed in the Cochrane library, MEDLINE, PsycINFO and Scopus databases. Prospective population-based studies and systematic reviews with meta-analyses of case control studies were taken into consideration for the statements. Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine version 2009. The statements were generated by multiple step formalized procedures. The guidelines were reviewed and approved by the board of directors of the societies engaged in the development of the guidelines.
Results:
Current data do not enable identification of distinct factors in the etiology and pathophysiology of fibromyalgia syndrome. Fibromyalgia syndrome can be associated with inflammatory rheumatic diseases, gene polymorphisms, life style factors (e.g. smoking, obesity and lack of physical activity), depressive disorders as well as physical and sexual abuse in childhood and adulthood.
Conclusion:
Fibromyalgia syndrome is most probably the end result of various pathogenetic factors and pathophysiological mechanisms.
The EULAR recommendations for the management of fibromyalgia are based on more than 100 reviews and meta-analyses of individual therapies and medicines.1 Thus, the quality of the evidence in making recommendations on effectiveness and efficacy is generally very high. In contrast, there is little published research …
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.
This systematic review aimed at evaluating the efficacy, acceptability and safety of guided imagery/hypnosis (GI/H) in fibromyalgia. Cochrane Library, MEDLINE, PsycINFO and SCOPUS were screened through February 2016. Randomized controlled trials (RCTs) comparing GI/H with controls were analysed. Primary outcomes were ≥50% pain relief, ≥20% improvement of health-related quality of life, psychological distress, disability, acceptability and safety at end of therapy and 3-month follow-up. Effects were summarized by a random effects model using risk differences (RD) or standardized mean differences (SMD) with 95% confidence intervals (CI).Seven RCTs with 387 subjects were included into a comparison of GI/H versus controls. There was a clinically relevant benefit of GI/H compared to controls on ≥50% pain relief [RD 0.18 (95% CI 0.02, 0.35)] and psychological distress [SMD -0.40 (95% CI -0.70, -0.11)] at the end of therapy. Acceptability at the end of treatment for GI/H was not significantly different to the control. Two RCTs with 95 subjects were included in the comparison of hypnosis combined with cognitive behavioural therapy (CBT) versus CBT alone. Combined therapy was superior to CBT alone in reducing psychological distress at the end of therapy [SMD -0.50 (95% CI -0.91, -0.09)]. There were no statistically significant differences between combined therapy and CBT alone in other primary outcomes at the end of treatment and follow-up. No study reported on safety. GI/H hold promise in a multicomponent management of fibromyalgia.
Significance:
We provide a systematic review with meta-analysis on guided imagery and hypnosis for fibromyalgia. Current analyses endorse the efficacy and tolerability of guided imagery/hypnosis and of the combination of hypnosis with cognitive-behavioural therapy in reducing key symptoms of fibromyalgia.
Several recent reviews have evaluated evidence on the efficacy of Mindfulness-Based Stress Reduction (MBSR) among fibromyalgia sufferers, and concluded that more research should test effects on both psychological and physiological functioning.
We conducted a randomized prospective trial of MBSR among female fibromyalgia patients.
Effects on perceived stress, pain, sleep quality, fatigue, symptom severity, and salivary cortisol were tested in treatment (n = 51) versus wait-list control participants (n = 40) using data at baseline, post-program, and 2-month follow-up.
Analyses revealed that MBSR significantly reduced perceived stress, sleep disturbance, and symptom severity, with gains maintained at follow-up. Greater home practice at follow-up was associated with reduced symptom severity. MBSR did not significantly alter pain, physical functioning, or cortisol profiles.
MBSR ameliorated some of the major symptoms of fibromyalgia and reduced subjective illness burden. Further exploration of MBSR effects on physiological stress responses is warranted. These results support use of MBSR as a complementary treatment for women with fibromyalgia (ISRCTN: 34628811).
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.
Objectives. Biofeedback (BFB) is an established intervention in the rehabilitation of headache and other pain disorders. Little is known about this treatment option for fibromyalgia syndrome (FMS). The aim of the present review is to integrate and critically evaluate the evidence regarding the efficacy of biofeedback for FMS. Methods. We conducted a literature search using Pubmed, clinicaltrials.gov (National Institute of Health), Cochrane Central Register of Controlled Trials, PsycINFO, SCOPUS, and manual searches. The effect size estimates were calculated using a random-effects model. Results. The literature search produced 123 unique citations. One hundred sixteen records were excluded. The meta-analysis included seven studies (321 patients) on EEG-Biofeedback and EMG-Biofeedback. In comparison to control groups, biofeedback (BFB) significantly reduced pain intensity with a large effect size (g = 0.79; 95% CI: 0.22-1.36). Subgroup analyses revealed that only EMG-BFB and not EEG-BFB significantly reduced pain intensity in comparison to control groups (g = 0.86; 95% CI: 0.11-1.62). BFB did not reduce sleep problems, depression, fatigue, or health-related quality of life in comparison to a control group. Discussion. The interpretation of the results is limited because of a lack of studies on the long-term effects of EMG-BFB in FMS. Further research should focus on the long-term efficacy of BFB in fibromyalgia and on the identification of predictors of treatment response.
Fibromyalgia (FM) is a clinically well-defined chronic condition of unknown aetiology characterized by chronic widespread pain that often co-exists with sleep disturbances, cognitive dysfunction and fatigue. Patients often report high disability levels and negative mood. Psychotherapies focus on reducing key symptoms, improving daily functioning, mood and sense of personal control over pain.
To assess the benefits and harms of cognitive behavioural therapies (CBTs) for treating FM at end of treatment and at long-term (at least six months) follow-up.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE (1966 to 28 August 2013), PsycINFO (1966 to 28 August 2013) and SCOPUS (1980 to 28 August 2013). We searched http://www.clinicaltrials.gov (web site of the US National Institutes of Health) and the World Health Organization Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/) for ongoing trials (last search 28 August,2013), and the reference lists of reviewed articles.
We selected randomised controlled trials of CBTs with children, adolescents and adults diagnosed with FM.
The data of all included studies were extracted and the risks of bias of the studies were assessed independently by two review authors. Discrepancies were resolved by discussion.
Twenty-three studies with 24 study arms with CBTs were included. A total of 2031 patients were included; 1073 patients in CBT groups and 958 patients in control groups. Only two studies were without any risk of bias. The GRADE quality of evidence of the studies was low. CBTs were superior to controls in reducing pain at end of treatment by 0.5 points on a scale of 0 to 10 (standardised mean difference (SMD) - 0.29; 95% confidence interval (CI) -0.49 to -0.17) and by 0.6 points at long-term follow-up (median 6 months) (SMD -0.40; 95% CI -0.62 to -0.17); in reducing negative mood at end of treatment by 0.7 points on a scale of 0 to 10 (SMD - 0.33; 95% CI -0.49 to -0.17) and by 1.3 points at long-term follow-up (median 6 months) (SMD -0.43; 95% CI -0.75 to -0.11); and in reducing disability at end of treatment by 0.7 points on a scale of 0 to 10 (SMD - 0.30; 95% CI -0.51 to -0.08) and at long-term follow-up (median 6 months) by 1.2 points (SMD -0.52; 95% CI -0.86 to -0.18). There was no statistically significant difference in dropout rates for any reasons between CBTs and controls (risk ratio (RR) 0.94; 95% CI 0.65 to 1.35).
CBTs provided a small incremental benefit over control interventions in reducing pain, negative mood and disability at the end of treatment and at long-term follow-up. The dropout rates due to any reason did not differ between CBTs and controls.
Studying the epidemiology of fibromyalgia (FM) is very important to understand the impact of this disorder on persons, families and society. The recent modified 2010 classification criteria of the American College of Rheumatology (ACR), without the need of tender points palpation, allows that larger and nationwide surveys may be done, worldwide. This article reviews the prevalence and incidence studies done in the general population, in several countries/continents, the prevalence of FM in special groups/settings, the association of FM with some sociodemographic characteristics of the population, and the comorbidity of FM with others disorders, especially with headaches.
Fibromyalgia (FM) is a chronic disorder characterized by widespread, persistent pain. Prospective and retrospective studies have demonstrated substantial health-care costs associated with FM in a number of countries. This study evaluated and compared health-resource use (HRU) and associated costs related to FM in routine clinical practice across the US, France, and Germany.
Two separate, cross-sectional, observational studies of subjects with FM were conducted: one in the US and one in France and Germany. HRU related to prescription medication, physician office visits, diagnostic tests, and hospitalizations was abstracted from chart review; patient out-of-pocket costs and lost productivity were collected via subject self-report. Costs were assigned to HRU based on standard algorithms. Direct and indirect costs were evaluated and compared by simple linear regression.
A total of 442 subjects (203 US, 70 France, 169 Germany) with FM were analyzed. The mean (standard deviation) age in the US, France, and Germany was 47.9 (10.9), 51.2 (9.5), and 49.2 (9.8), respectively (P = 0.085). Most subjects were female (95% US, 83% France, 80% Germany) (P < 0.001). Adjusted annual direct costs per subject for FM were significantly higher in the US ($7087) than in France ($481, P < 0.001) or Germany ($2417, P < 0.001). Adjusted mean annual indirect costs per subject for FM were lower in the US ($6431) than in France ($8718) or Germany ($10,001), but represented a significant proportion of total costs in all countries.
The significant HRU and costs associated with FM in the US, France, and Germany documented in this study highlight the substantial global economic burden of FM. Indirect costs represented a significant proportion of the total costs, particularly in Europe. Comparisons between the three countries show differences in HRU, with significantly higher direct costs in the US compared with France and Germany.
Objectives:
To synthesise the available evidence on pharmacological and non-pharmacological interventions recommended for fibromyalgia syndrome (FMS).
Methods:
Electronic databases including MEDLINE, PsycINFO, Scopus, the Cochrane Controlled Trials Registry and the Cochrane Library were searched for randomised controlled trials comparing any therapeutic approach as recommended in FMS guidelines (except complementary and alternative medicine) with control interventions in patients with FMS. Primary outcomes were pain and quality of life. Data extraction was done using standardised forms.
Results:
102 trials in 14 982 patients and eight active interventions (tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors (SNRIs), the gamma-amino butyric acid analogue pregabalin, aerobic exercise, balneotherapy, cognitive behavioural therapy (CBT), multicomponent therapy) were included. Most of the trials were small and hampered by methodological quality, introducing heterogeneity and inconsistency in the network. When restricted to large trials with ≥100 patients per group, heterogeneity was low and benefits for SNRIs and pregabalin compared with placebo were statistically significant, but small and not clinically relevant. For non-pharmacological interventions, only one large trial of CBT was available. In medium-sized trials with ≥50 patients per group, multicomponent therapy showed small to moderate benefits over placebo, followed by aerobic exercise and CBT.
Conclusions:
Benefits of pharmacological treatments in FMS are of questionable clinical relevance and evidence for benefits of non-pharmacological interventions is limited. A combination of pregabalin or SNRIs as pharmacological interventions and multicomponent therapy, aerobic exercise and CBT as non-pharmacological interventions seems most promising for the management of FMS.
To systematically assess the potential association of fibromyalgia syndrome (FMS) with emotional, physical, and sexual abuse.
The databases EMBase, Google Scholar, Medline, and PsycINFO (through April 2010) and the reference sections of original studies were searched for eligible studies. Eligible studies were cohort or case--control studies that assessed at least one type of emotional, physical, or sexual abuse in childhood or adulthood in patients with FMS and in controls. Two authors independently extracted descriptive, quality, and outcome data from included studies. Methodologic quality was assessed by the Newcastle-Ottawa Quality Assessment Scale. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were pooled across studies by using the random-effects model. Heterogeneity was assessed by I(2) statistics.
The search identified 18 eligible case-control studies with 13,095 subjects. There were significant associations between FMS and self-reported physical abuse in childhood (OR 2.49 [95% CI 1.81-3.42], I(2) = 0%; 9 studies) and adulthood (OR 3.07 [95% CI 1.01-9.39], I(2) = 79%; 3 studies), and sexual abuse in childhood (OR 1.94 [95% CI 1.36-2.75], I(2) = 20%; 10 studies) and adulthood (OR 2.24 [95% CI 1.07-4.70], I(2) = 64%; 4 studies). Study quality was mostly poor. Low study quality was associated with higher effect sizes for sexual abuse in childhood, but not with other effect sizes.
The association of FMS with physical and sexual abuse could be confirmed, but is confounded by study quality.
Hypnosis treatment in general practice is a rather new concept. This pilot study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP).
The study was designed as a randomized control group-controlled study. Sixteen patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering. Data were analyzed by means of T-tests.
The treatment group improved from their symptoms, (change from 62.5 to 55.4), while the control group deteriorated, (change from 37.2 to 45.1), (p = 0,045). The 12 patients who completed the treatment showed a mean improvement from 51.5 to 41.6. (p = 0,046). One year later the corresponding result was 41.3, indicating a persisting improvement.
The study indicates that hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. Considering the limited number of patients, more studies should be conducted to confirm the results.
The study was registered in ClinicalTrials.gov and released 27.08.07 Reg nr NCT00521807 Approval Number: 05032001.
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 greater than or equal to 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.
In this study, 67 participants (95% female) with fibromyalgia (FM) were randomly assigned to an online acceptance and commitment therapy (online ACT) and treatment as usual (TAU; ACT + TAU) protocol or a TAU control condition. Online ACT + TAU participants were asked to complete 7 modules over an 8-week period. Assessments were completed at pre-treatment, post-treatment, and 3-month follow-up periods and included measures of FM impact (primary outcome), depression, pain, sleep, 6-minute walk, sit to stand, pain acceptance (primary process variable), mindfulness, cognitive fusion, valued living, kinesiophobia, and pain catastrophizing. The results indicated that online ACT + TAU participants significantly improved in FM impact, relative to TAU (P <.001), with large between condition effect sizes at post-treatment (1.26) and follow-up (1.59). Increases in pain acceptance significantly mediated these improvements (P = .005). Significant improvements in favor of online ACT + TAU were also found on measures of depression (P = .02), pain (P = .01), and kinesiophobia (P = .001). Although preliminary, this study highlights the potential for online ACT to be an efficacious, accessible, and cost-effective treatment for people with FM and other chronic pain conditions.
Perspective
Online ACT reduced FM impact relative to a TAU control condition in this randomized controlled trial. Reductions in FM impact were mediated by improvements in pain acceptance. Online ACT appears to be a promising intervention for FM.
Objective:
It is uncertain whether persons with chronic widespread pain (CWP) experience premature mortality. Using the largest study conducted, we determine whether such a relationship exists, estimate its magnitude and establish what factors mediate any relationship.
Methods:
UK Biobank, a cohort study of 0.5 million people aged 40-69 years, recruited throughout Great Britain in 2006-2010. Participants reporting 'pain all over the body' for >3 months were compared with persons without chronic pain. Information on death (with cause) was available until mid-2015. We incorporated these results in a meta-analysis with other published reports to calculate a pooled estimate of excess risk.
Results:
7130 participants reported CWP and they experienced excess mortality (mortality risk ratio 2.43, 95%CI 2.17 to 2.72). Specific causes of death in excess were cancer (1.73adjusted age and sex, 95% CI 1.46 to 2.05), cardiovascular (3.24adjusted age and sex, 95% CI 2.55 to 4.11), respiratory (5.66adjusted age and sex, 95% CI 4.00 to 8.03) and other disease-related causes (4.04adjusted age and sex, 95% CI 3.05 to 5.34). Excess risk was substantially reduced after adjustment for low levels of physical activity, high body mass index, poor quality diet and smoking. In meta-analysis, all studies showed significant excess all-cause (combined estimate 1.59 (95% CI 1.05 to 2.42)), cardiovascular and cancer mortality.
Conclusions:
Evidence is now clear that persons with CWP experience excess mortality. UK Biobank results considerably reduce uncertainty around the magnitude of excess risk and are consistent with the excess being explained by adverse lifestyle factors, which could be targeted in the management of such patients.
Objectives:
The provisional criteria of the American College of Rheumatology (ACR) 2010 and the 2011 self-report modification for survey and clinical research are widely used for fibromyalgia diagnosis. To determine the validity, usefulness, potential problems, and modifications required for the criteria, we assessed multiple research reports published in 2010-2016 in order to provide a 2016 update to the criteria.
Methods:
We reviewed 14 validation studies that compared 2010/2011 criteria with ACR 1990 classification and clinical criteria, as well as epidemiology, clinical, and databank studies that addressed important criteria-level variables. Based on definitional differences between 1990 and 2010/2011 criteria, we interpreted 85% sensitivity and 90% specificity as excellent agreement.
Results:
Against 1990 and clinical criteria, the median sensitivity and specificity of the 2010/2011 criteria were 86% and 90%, respectively. The 2010/2011 criteria led to misclassification when applied to regional pain syndromes, but when a modified widespread pain criterion (the "generalized pain criterion") was added misclassification was eliminated. Based on the above data and clinic usage data, we developed a (2016) revision to the 2010/2011 fibromyalgia criteria. Fibromyalgia may now be diagnosed in adults when all of the following criteria are met: CONCLUSIONS: The fibromyalgia criteria have good sensitivity and specificity. This revision combines physician and questionnaire criteria, minimizes misclassification of regional pain disorders, and eliminates the previously confusing recommendation regarding diagnostic exclusions. The physician-based criteria are valid for individual patient diagnosis. The self-report version of the criteria is not valid for clinical diagnosis in individual patients but is valid for research studies. These changes allow the criteria to function as diagnostic criteria, while still being useful for classification.
The problem of adverse effects of psychotherapy has been recognised for decades, yet research on causes and prevention of harm has failed to progress. There is confusion between different definitions and a lack of systematic recording and reporting. A new framework for moving this field forward is proposed.
The aim of this narrative review of the epidemiology of central sensitivity syndromes is to provide a summary of the role of early life adversity and psychosocial / psychological factors, in the epidemiology of six main syndromes: (i) fibromyalgia / chronic widespread pain; (ii) headache / migraine; (iii) irritable bowel syndrome; (iv) temporomandibular joint disorder; (v) interstitial cystitis; and (vi) endometriosis / vulvodynia / chronic pelvic pain. The occurrence of each of the above syndromes vary between each other, and between studies. Prevalence ranges from interstitial cystitis, with a prevalence of approximately 14.5 per 100,000, to headache, with some estimates of lifetime prevalence to be around 66%. Precise risk estimates vary between studies, conditions, and exposures, although there is consistent evidence to suggest an association between early life adversity and central sensitivity syndromes (based on the six syndromes under investigation). In further support of this, a number of studies have also demonstrated dose-risk associations. There is also considerable consistency in the literature to suggest a strong association between negative psychological and psychosocial factors, and the occurrence of central sensitivity syndromes and, again, there is some evidence of a dose-risk relationship. The majority of studies in this field are cross-sectional or retrospective in design, and caution is advised when interpreting results. It is possible - indeed there is some evidence - that some findings may be subject to recall bias, and reverse causation is also a potential concern. However, there are also a number of prospective studies which provide more robust evidence.
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:
There are no studies investigating the efficacy of short-term psychodynamic psychotherapy in primary fibromyalgia syndrome (FMS). We conducted a randomized controlled trial evaluating an adapted form of individual short-term psychodynamic psychotherapy (ASTPP) versus primary care management (TAU). The study focused on FMS patients with psychiatric comorbidity.
Methods:
Forty-six female patients with FMS and an International Classification of Diseases, 10th Revision diagnosis of a comorbid depression or anxiety disorder were recruited in a hospital setting. Participants were randomized to receive either ASTPP (25 sessions, 1 session/week) or TAU (4 consultations/6 months). Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Hospital Anxiety and Depression Scale (HADS), the Pain Disability Index, the Symptom Checklist 27 and the health-related quality of life. Primary endpoints of the outcome assessment were the FIQ total score and the HADS depression scale at 12-month follow-up.
Results:
Both treatments were effective in reducing the FIQ total score (ES=0.56 and ES=0.75, respectively). Intent-to-treat analyses failed to provide evidence suggesting a marked superiority of individual psychodynamic psychotherapy as compared to TAU.
Conclusions:
A high-standard routine treatment focusing on the improvement of health behavior and including antidepressant and analgesic medication is equally effective as a short-term individual psychodynamic psychotherapy in improving fibromyalgia-related symptoms.
GRADE requires guideline developers to make an overall rating of confidence in estimates of effect (quality of evidence-high, moderate, low, or very low) for each important or critical outcome. GRADE suggests, for each outcome, the initial separate consideration of five domains of reasons for rating down the confidence in effect estimates, thereby allowing systematic review authors and guideline developers to arrive at an outcome-specific rating of confidence. Although this rating system represents discrete steps on an ordinal scale, it is helpful to view confidence in estimates as a continuum, and the final rating of confidence may differ from that suggested by separate consideration of each domain. An overall rating of confidence in estimates of effect is only relevant in settings when recommendations are being made. In general, it is based on the critical outcome that provides the lowest confidence.
To determine the relationship between physically traumatic events and the onset of chronic widespread pain (CWP).
This was a case-control study nested within a large prospective cohort. CWP was determined, by questionnaire, as per the American College of Rheumatology fibromyalgia classification criteria. Data were also collected on psychological health, health behavior, and sleep problems. Participants without CWP were then followed up at 4 years, and (new-onset) CWP was determined in the same manner. At followup, participants were also asked to report whether they had experienced any of a series of physically traumatic events between baseline and followup.
A total of 2,069 individuals (46.6%) participated at followup, and 241 of these individuals (11.6%) reported CWP. More than one-third of the study population reported at least 1 physically traumatic event; although these individuals were more likely to develop CWP, this relationship was completely attenuated after adjustment for confounding (odds ratio 1.01, 95% confidence interval 0.73-1.40). However, there was some evidence to suggest that involvement in a road traffic accident, specifically, may confer an increase in the risk of CWP onset.
This study provides support for the "at risk" phenotype hypothesis, where individuals characterized by poorer health and psychological variables may be predisposed to develop CWP following a traumatic trigger. However, although this has been seen with road traffic accidents, it is not the case with other events. Future research should examine what is peculiar about an accident, or about one's reaction to it, that confers this increase in the risk of CWP onset.
Acceptance-based interventions such as mindfulness-based stress reduction program and acceptance and commitment therapy are alternative therapies for cognitive behavioral therapy for treating chronic pain patients. To assess the effects of acceptance-based interventions on patients with chronic pain, we conducted a systematic review and meta-analysis of controlled and noncontrolled studies reporting effects on mental and physical health of pain patients. All studies were rated for quality. Primary outcome measures were pain intensity and depression. Secondary outcomes were anxiety, physical wellbeing, and quality of life. Twenty-two studies (9 randomized controlled studies, 5 clinical controlled studies [without randomization] and 8 noncontrolled studies) were included, totaling 1235 patients with chronic pain. An effect size on pain of 0.37 was found for the controlled studies. The effect on depression was 0.32. The quality of the studies was not found to moderate the effects of acceptance-based interventions. The results suggest that at present mindfulness-based stress reduction program and acceptance and commitment therapy are not superior to cognitive behavioral therapy but can be good alternatives. More high-quality studies are needed. It is recommended to focus on therapies that integrate mindfulness and behavioral therapy. Acceptance-based therapies have small to medium effects on physical and mental health in chronic pain patients. These effects are comparable to those of cognitive behavioral therapy.
To determine if mortality is increased among patients diagnosed as having fibromyalgia.
We studied 8,186 fibromyalgia patients seen between 1974 and 2009 in 3 settings: all fibromyalgia patients in a clinical practice, patients participating in the US National Data Bank for Rheumatic Diseases (NDB), and patients invited to participate in the NDB who refused participation. Internal controls included 10,087 patients with osteoarthritis. Deaths were determined by multiple source communication, and all patients were also screened in the US National Death Index (NDI). We calculated standardized mortality ratios (SMRs) based on age- and sex-stratified US population data, after adjustment for NDI nonresponse.
There were 539 deaths, and the overall SMR was 0.90 (95% confidence interval [95% CI] 0.61-1.26). Among 1,665 clinic patients, the SMR was 0.92 (95% CI 0.81-1.05). Sensitivity analyses varying the rate of NDI nonidentification did not alter the nonassociation. Adjusted for age and sex, the hazard ratio for fibromyalgia compared with osteoarthritis was 1.05 (95% CI 0.94-1.17). The standardized mortality odds ratio (OR) compared with the US general population was increased for suicide (OR 3.31, 95% CI 2.15-5.11) and for accidental deaths (OR 1.45, 95% CI 1.02- 2.06), but not for malignancy.
Mortality does not appear to be increased in patients diagnosed with fibromyalgia, but the risk of death from suicide and accidents was increased.
Background:
Behavioural treatment is commonly used in the management of chronic low-back pain (CLBP) to reduce disability through modification of maladaptive pain behaviours and cognitive processes. Three behavioural approaches are generally distinguished: operant, cognitive, and respondent; but are often combined as a treatment package.
Objectives:
To determine the effects of behavioural therapy for CLBP and the most effective behavioural approach.
Search strategy:
The Cochrane Back Review Group Trials Register, CENTRAL, MEDLINE, EMBASE, and PsycINFO were searched up to February 2009. Reference lists and citations of identified trials and relevant systematic reviews were screened.
Selection criteria:
Randomised trials on behavioural treatments for non-specific CLBP were included.
Data collection and analysis:
Two review authors independently assessed the risk of bias in each study and extracted the data. If sufficient homogeneity existed among studies in the pre-defined comparisons, a meta-analysis was performed. We determined the quality of the evidence for each comparison with the GRADE approach.
Main results:
We included 30 randomised trials (3438 participants) in this review, up 11 from the previous version. Fourteen trials (47%) had low risk of bias. For most comparisons, there was only low or very low quality evidence to support the results. There was moderate quality evidence that:i) operant therapy was more effective than waiting list (SMD -0.43; 95%CI -0.75 to -0.11) for short-term pain relief;ii) little or no difference exists between operant, cognitive, or combined behavioural therapy for short- to intermediate-term pain relief;iii) behavioural treatment was more effective than usual care for short-term pain relief (MD -5.18; 95%CI -9.79 to -0.57), but there were no differences in the intermediate- to long-term, or on functional status;iv) there was little or no difference between behavioural treatment and group exercise for pain relief or depressive symptoms over the intermediate- to long-term;v) adding behavioural therapy to inpatient rehabilitation was no more effective than inpatient rehabilitation alone.
Authors' conclusions:
For patients with CLBP, there is moderate quality evidence that in the short-term, operant therapy is more effective than waiting list and behavioural therapy is more effective than usual care for pain relief, but no specific type of behavioural therapy is more effective than another. In the intermediate- to long-term, there is little or no difference between behavioural therapy and group exercises for pain or depressive symptoms. Further research is likely to have an important impact on our confidence in the estimates of effect and may change the estimates.
A previous study demonstrated an association between self-reported widespread body pain and increased mortality. The aim of this study was to analyze whether fibromyalgia (FM) and FM-like symptoms are related to increased mortality.
From hospital records, we identified 1,361 patients referred during the period 1984-1999 because of the suspicion of FM. The cases were reviewed by reviewers who were blinded to the outcome. The cohort was followed up for a total of 5,295 person-years at risk and was linked to the Danish Mortality Register. Using the number of years at risk and sex-, age-, and calendar-specific mortality rates from the general population, cause-specific standardized mortality ratios [SMRs] were calculated.
We observed no overall increased mortality among patients with FM. Among the 1,269 female patients, the SMRs (95% confidence intervals [95% CIs]) for an increased risk of death from suicide, liver cirrhosis/biliary tract disease, and cerebrovascular disease were 10.5 (95% CI 4.5-20.7), 6.4 (95% CI 2.3-13.9), and 3.1 (95% CI 1.1-6.8), respectively. The suicide risk was increased at the time of diagnosis and remained increased after 5 years. Patients meeting the American College of Rheumatology criteria for FM and patients with possible FM had the same cause-specific mortality pattern. No increased cause-specific mortality was observed in the 84 male patients.
The causes of a markedly increased rate of suicide among female patients with FM are at present unknown but may be related to increased rates of lifetime depression, anxiety, and psychiatric disorders. Risk factors for suicide should be sought at the time of the diagnosis of FM and at followup. The results also suggest that risk factors for liver disease and cerebrovascular disease should be evaluated in patients with FM.
Electromyogram-Biofeedback in Patients with Fibromyalgia: A Randomized Controlled Trial
Objective: To evaluate the effectiveness of EMG-biofeedback in patients with Fibromyalgia. Design: The study design was a randomized controlled pilot trial with blinded assessors and three points of assessment: before intervention (baseline, T0), at the end of treatment (T1) and a 3-months follow-up (T2).
Setting: Outpatient clinic.
Patients: Patients from the waiting list of the Fibromyalgia day hospital program fulfilling the inclusion criteria.
Intervention: During eight weeks, 14 sessions of EMG-biofeedback training versus usual care only.
Outcome Measures and Analysis: For primary outcome, the disease specific health status was followed using the Fibromyalgia Impact Questionnaire (FIQ). Secondary outcome measures comprise assessment of pain (Tender Point Score), tenderness (Tender Point Count = number of Tender Points, Pain Pressure Threshold), generic health status (SF-36), Patients’ Global Clinical Impression of Change and psychic impact (Beck depression Inventory, Symptom Checklist 90-Revised). Effects were analyzed with sensitivity statistics (effect size, ES), parametric and nonparametric tests.
Results: The data of 36 patients with complete follow-up data could be analyzed. EMG-EMG-biofeedback did not improve health status of patients with Fibromyalgia (FIQ, T1: ES = 0.02, p = 0.95, T2: ES = 0.26, p = 0.43). Also, the secondary outcome measures, with the exception of the pressure pain threshold (T1: ES = 0.26, p = 0.014), showed no superiority of EMG-biofeedback in addition to usual care compared to usual care alone.
Conclusion: In the treatment of patients with Fibromyalgia, EMG-biofeedback training in addition to usual medical care is not superior to usual medical care alone.
Many pain patients appreciate biofeedback interventions because of the integration of psychological and physiological aspects. Therefore we wanted to investigate in a sample of chronic back pain patients whether biofeedback ingredients lead to improved outcome of psychological interventions.
One hundred and twenty-eight chronic back pain patients were randomly assigned to cognitive-behavioural therapy (CBT), cognitive-behavioural therapy including biofeedback tools (CBT-B) or waitlist control (WLC). The sample was recruited from a highly disabled group including many patients with low education status and former back surgeries. Measures on pain, physical functioning, emotional functioning, coping strategies and health care utilisation were taken at pretreatment, posttreatment and 6 months of follow-up.
The results indicated significant improvements on most outcome measures for CBT-B and CBT in comparison to WLC. CBT-B and CBT were equally effective (e.g. ITT effect sizes for pain intensity: CBT-B, 0.66 (95% CI 0.39-0.95); CBT, 0.60 (95% CI 0.33-0.87)).
In conclusion, biofeedback ingredients did not lead to improved outcome of a psychological intervention. Cognitive-behavioural treatment as a "package" of respondent, operant and cognitive interventions was effective for ameliorating pain-related symptoms for chronic back pain patients treated in an outpatient setting. The high treatment acceptability associated with biofeedback ingredients can also be achieved with pure psychological interventions.
- S Butler
- T Landmark
- M Glette
Butler S, Landmark T, Glette M, et al. Pain 2016;157:541e3.
Jones / Best Practice & Research Clinical Rheumatology xxx (xxxx) xxx
- W Auser
W. H€ auser, G. Jones / Best Practice & Research Clinical Rheumatology xxx (xxxx) xxx