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Background Patients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients’ knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction. Methods In total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T0; after intervention, T1; and 3 months after intervention, T2). The main outcome is the patient’s knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T1 and T2. Discussion This trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma. Trial registration ClinicalTrials.gov NCT04240717. Registered on 27 January 2020

OBJECTIVES The relationship between changes in symptom severity and health-related quality of life (HRQOL), which may be impacted by stressful life events, in irritable bowel syndrome (IBS), is unclear. Therefore, we investigated the relationship between changes in symptom severity and HRQOL and examined the moderating role of stressful life events in patients with IBS. METHODS This study is part of a cohort follow-up study on psychological factors in patients with IBS in tertiary care, and it included 158 patients. In addition to symptom severity and HRQOL, stressful life events were assessed by the Social Readjustment Rating Scale (SRRS). The relationship between symptom severity and HRQOL and the moderating role of stressful life events (in the 12 mo before the follow-up assessment) were analyzed. RESULTS The majority of participants had moderate levels of stressful life events (41.8%), followed by those who had mild levels (39.2%) and severe levels (19.0%) of stressful life events. Symptom severity could predict HRQOL, and the relationship between symptom severity and HRQOL was affected by the level of stressful life events. Compared with mild levels of stressful life events, a severe level of stressful life events significantly affected the relationship between changes in symptom severity and HRQOL (Z=-3.048, P

Aims: Is there evidence for increased psychological distress and alterations in personality functioning in patients with Crohn’s disease (CD) and ulcerative colitis (UC) compared to healthy controls (HCs)?Background: In patients with CD and UC, perceived stress is closely associated with changes in disease activity. The stress response is influenced by psychological burden and personality functioning, but only little is known about these factors in inflammatory bowel diseases (IBD).Study: A total of 62 patients with an endoscopic ensured CD/UC without remission (n = 31 per group) and 31 HC were included. Patients with an active CD/UC and HC were individually matched (n = 93, 31 per group) for age, sex, education, and disease activity. Depression and anxiety were assessed to evaluate the effect of psychological burden (Patient Health Questionnaire-9/PHQ-9, Generalized Anxiety Disorder-7/GAD-7). Personality functioning was measured by validated questionnaires for psychodynamic structural characteristics, mentalization, and attachment (Operationalized Psychodynamic Diagnosis-Structure Questionnaire/OPD-SQ, Mentalization Questionnaire/MZQ, and Experiences in Close Relationships scale/ECR-RD 12).Results: Levels of depression and anxiety were higher in CD/UC patients than in HC with large effect sizes. Comparing personality functioning in CD/UC with HC, psychodynamic structural characteristics differed between CD/UC and HC with medium effect sizes, with structural differences occurring primarily in the domain of self-perception and regulation. Only minor differences were found regarding mentalization and attachment. CD and UC differed only with small effect sizes.Conclusion: Our data show that compared to HC, patients with CD/UC are characterized by a higher level of psychological burden and structural alterations in the domain of self.

Objective: Deficits in affective processing are associated with impairments in both mental and physical health. The role of affective processing in patients with functional somatic complaints such as irritable bowel syndrome (IBS) remains unclear. Most studies have focused on the capacity for emotional awareness and expression, but neglect other dimensions of affective processing. Therefore, this study aimed to systematically analyze differences in six different dimensions of affective processing between patients with IBS and healthy controls (HCs). Additionally, we exploratively investigated the impact of IBS symptom severity, psychological distress, and attachment styles on affective processing in IBS.Methods: A controlled cross-sectional multi-center study was conducted. Overall, 127 patients with IBS were compared with 127 matched HCs using multivariate analysis of variances. Affective processing was operationalized in line with the affect cascade model on six specific dimensions: emotional experience, emotional awareness, affect tolerance, affect differentiation, affect regulation, and emotional communication. They were measured using two subscales of the Mentalizing Questionnaire (MZQ) and four subscales of the Operationalized Psychodynamic Diagnosis–Structure Questionnaire (OPD-SQ). Linear regression analysis was used to investigate the influence of IBS symptom severity (IBS-Severity Scoring System, IBS-SSS), depression (Patient Health Questionnaire, PHQ-9), anxiety (General Anxiety Disorder, GAD-7), and anxious and avoidant attachment styles (Experiences in Close Relationships Scale, ECR-RD12) on the different dimensions of affective processing in IBS.Results: Patients with IBS compared to HCs showed deficits in all six dimensions of affective processing. Deficits were largest for affect tolerance (d = 0.849) and lowest for emotional experience (d = 0.222) and emotional awareness (d = 0.420). Moderate effect sizes were found for affect differentiation (d = 0.773), emotional communication (d = 0.665), and affect regulation (d = 0.552). Moreover, explorative analyses indicated that affective processing in patients with IBS was significantly influenced by levels of anxiety and insecure attachment.Conclusion: The results indicate a specific pattern of affective processing abilities in patients with IBS. The deficits in affective processing are more prominent in the area of understanding and tolerating difficult affective states than experiencing affective states. This opens interesting perspectives for the development of specific psychotherapeutic interventions.Clinical Trial Registration: DRKS00011685.

Objective The detrimental impact of nonspecific chronic low back pain (CLBP) on quality of life is well known. However, patients with CLBP represent a remarkably heterogeneous group, and not all of them report compromised well-being. Methods In this study, we investigated this heterogeneity by identifying profiles (or clusters) of well-being and their correlates in 239 CLBP patients. To take the multidimensionality of subjective well-being into account, we included multiple well-being indicators (depression, anxiety, affective distress, perceived control over life). For an in-depth characterization of the well-being profiles, we assessed 1) sociodemographic indicators (age, gender, education, marital status, occupational status), 2) pain-related measures (pain intensity, subjective and objective pain disability, number of pain locations), 3) psychosocial resources (mental health, resilience, perceived support), 4) biographical factors (trauma), and 5) somatosensory profiles based on quantitative sensory testing. Results Based on two-step cluster analysis, we identified three distinct well-being profiles, characterized by either generally high well-being (cluster 1, n = 51), moderate well-being (cluster 2, n = 104), or consistently low well-being (cluster 3, n = 77), respectively. Most differences between the derived well-being profiles regarding sociodemographic, psychosocial, and biographical measures were of weak to moderate effect size. Larger effect sizes were observed for differences in pain intensity and subjective, but not objective, pain disability. Finally, the largest effects were found for differences in psychosocial resources. Conclusions Our findings suggest that not only in nonclinical samples, but also in patients with chronic pain, well-being is more closely associated with psychological resources and subjective evaluations than with objective parameters.

Objective Nonspecific chronic low back pain (CLBP) is a frequent medical condition among middle-aged and older adults. Its detrimental consequences for functional ability and quality of life are well known. However, less is known about associations of chronological age with disability and well-being among CLBP patients. Coping with pain may be harder with advancing age due to additional age-associated losses of physical, sensory, and other resources, resulting in higher disability and lower quality of life. Alternatively, older patients may feel less impaired and report higher quality of life than younger patients because the experience of chronic pain may be better anticipated and more “normative” in old age. Methods We investigated an age-heterogeneous sample of 228 CLBP patients (mean age = 59.1 years, SD = 10.2 years, range 41–82 years). Our outcomes were pain intensity, pain disability (as assessed by self-reported activity restrictions and performance-based tests), and measures of quality of life (health-related quality of life: SF-12 physical and mental health; well-being: anxiety, depression, perceived control over life, affective distress). Results Although older patients had higher performance-based disability, they scored higher on mental health and on most measures of well-being than younger patients. Conclusions Our findings provide evidence for a “paradoxical” pattern of age effects in CLBP patients and are thus in line with other studies based on nonclinical samples: Although disability in CLBP patients increases with advancing age, indicators of quality of life are equal or even higher in older patients.

Objective The purpose of this study was to investigate key factors related to lifestyle changes following acute myocardial infarction (AMI) by eliciting survivors’ subjective needs for, attitudes towards and experiences with behaviour changes in their everyday life to improve future interventions promoting lifestyle changes. Methods Semi-structured interviews were conducted with 21 individuals who had recently experienced an AMI. The interviews were audio-recorded and transcribed verbatim. The data were analysed using qualitative content analysis. Results The data analysis revealed that lifestyle changes following AMI are influenced by a combination of individual (physical and psychological) and social factors that can be grouped into facilitators and barriers. The interviews indicated the need for more personalised information regarding the causes and risk factors of illness, the benefits of lifestyle changes and the importance of including significant others in lifestyle advice and education and of individualising support. Discussion Lifestyle change is a continuous process that is not completed within a few months after a cardiac event. Considering the identified themes when developing interventions to promote lifestyle changes following AMI may enhance the effectiveness and sustainability of such interventions.

There has been a surging interest in the putative role of peripheral growth factors in the pathophysiology of fibromyalgia, specifically in the peripheral sensitization that occurs in chronic pain disorders. This cross-sectional study set out to assess and compare brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) in plasma samples from fibromyalgia patients and healthy controls. Plasma BDNF and NGF were measured in 89 fibromyalgia patients and 36 pain-free controls, and compared using ANCOVA controlling for potential confounders, as well as Bayesian methods for parameter estimation and model evaluation. BDNF and NGF levels in fibromyalgia patients did not differ from those in pain-free controls. Statistical methods were consistent, with both frequentist and Bayesian approaches leading to the same conclusions. Our study fails to replicate the finding that peripheral BDNF is altered in fibromyalgia, and instead our findings suggest that plasma levels of growth factor appear normative in fibromyalgia.

Objective Irritable bowel syndrome (IBS) and inflammatory bowel diseases (IBD) have similar symptoms and are affected by psychological factors via gut-brain-interactions. However, previous studies on IBS and IBD showed inconsistent results regarding psychological factors, potentially because they failed to consider the impact of symptom activity. The aim of this study was 1) to compare psychological distress and psychological risk factors among patients with IBS, IBD and healthy controls (HC), and 2) to assess the impact of symptom activity. Methods A controlled cross-sectional study was conducted. Patients with IBS and IBD were recruited in several primary, secondary, and tertiary medical care units between 02 and 12/2017 in Germany. Overall, 381 matched participants (127/group, 63% female) were included. For the second analyses, patients with IBD were distinguished in patients with active (n = 93) and non-active (n = 34) symptoms. Psychological distress (somatization, depression, anxiety, and illness anxiety) and risk factors (adverse childhood experiences, attachment style, and mentalizing capacity) were measured. Results Patients with IBS showed higher psychological distress and more psychological risk factors than patients with IBD and HC. However, patients with IBD and active symptoms showed similar psychological distress than patients with IBS, except for lower illness anxiety (p Conclusion With the exception of higher illness anxiety in IBS patients, differences in psychological factors between patients with IBS and IBD were more strongly associated with symptom activity than with the underlying diagnosis. Therefore, this study challenges previous concepts of distinguishing functional and organic gastrointestinal diseases, but highlights the role of symptom activity and illness anxiety. Trial registration DRKS00011685.

The aims of this study are to assess patients’ preferred and perceived decision-making roles and preference matching in a sample of German breast and colon cancer patients and to investigate how a shared decision-making (SDM) intervention for oncologists influences patients’ preferred and perceived decision-making roles and the attainment of preference matches. This study is a post hoc analysis of a randomised controlled trial (RCT) on the effects of an SDM intervention. The SDM intervention was a 12-h SDM training program for physicians in combination with decision board use. For this study, we analysed a subgroup of 107 breast and colon cancer patients faced with serious treatment decisions who provided data on specific questionnaires with regard to their preferred and perceived decision-making roles (passive, SDM or active). Patients filled in questionnaires immediately following a decision-relevant consultation (t1) with their oncologist. Eleven of these patients’ 27 treating oncologists had received the SDM intervention within the RCT. A majority of cancer patients (60%) preferred SDM. A match between preferred and perceived decision-making roles was reached for 72% of patients. The patients treated by SDM-trained physicians perceived greater autonomy in their decision making (p

Objectives The aim of this study was to examine visual function and eye symptoms in fibromyalgia patients, with a particular focus on dry eye syndrome and eye pain. Methods A tertiary care center-based cross-sectional study was carried out in chronic musculoskeletal pain patients diagnosed with fibromyalgia. Chronic musculoskeletal pain patients without fibromyalgia were enrolled as a comparison group. Self-reported eye pain was investigated with the McGill pain questionnaire and the numeric rating scale. In addition, we assessed corrected visual acuity, vision-related quality of life, and self-reported dry eye syndrome. Results A total of 90 musculoskeletal pain patients were included, with 66 patients fulfilling American College of Rheumatology 1990 criteria for fibromyalgia. Sixty-seven percent (95% confidence interval [CI] = 56%-78%) of the fibromyalgia patients reported eye pain, and 62% (95% CI = 43%-81%) of those were without fibromyalgia diagnosis. Sixty-seven percent (95% CI = 56%-78%) of the fibromyalgia patients reported an experience of dry eye compared with 76% (95% CI = 57%-95%) in the nonfibromyalgia group. Vision-related quality of life was noticeably reduced in both groups. Conclusions Eye pain and dry eye are common in chronic pain patients, with comparable prevalence in musculoskeletal pain patients with and without fibromyalgia.

Psychological trauma is associated with an increased risk for chronification of nonspecific chronic back pain (nsCLBP) independent of posttraumatic stress disorder (PTSD). However, the mechanisms underlying the role of psychological trauma in nsCLBP are less clear than in PTSD. Therefore, this study considered whether psychological trauma exposure (TE) is accompanied by specific alterations in pain perception. The study included 56 participants with nsCLBP and TE (nsCLBP-TE), 93 participants with nsCLBP without TE (nsCLBP-W-TE), and 31 pain-free controls. All participants underwent a thorough clinical evaluation. The standardized quantitative sensory testing protocol of the "German Research Network on Neuropathic Pain" was used to obtain comprehensive profiles on somatosensory functions in painful (back) and non-painful areas (hand). The protocol consisted of thermal and mechanical detection as well as pain thresholds, vibration thresholds, and pain sensitivity to sharp and blunt mechanical stimuli. Psychological trauma was validated by structured clinical interview. Trauma-associated symptom severity, anxiety, and depressive symptomatology were assessed by self-report questionnaires. Differences in somatosensory function were seen only for pressure pain thresholds. Compared with controls, nsCLBP-TE revealed hyperalgesia generalized in space with lower thresholds in painful and non-painful areas, whereas nsCLBP-W-TE demonstrated localized alterations with decreased thresholds only in the pain-affected area of the back (P ≤ 0.006). Our findings suggest an augmented central pain processing in nsCLBP-TE (alterations in painful and non-painful areas), whereas nsCLBP-W-TE show only local changes (alterations only in the painful area) suggesting regional sensitization processes. This finding might explain why TE without PTSD is associated with an increased prevalence of chronic pain.

Objective This study systematically reviewed the evidence regarding the effects of eye movement desensitization and reprocessing (EMDR) therapy for treating chronic pain. Design Systematic review. Methods We screened MEDLINE, EMBASE, the Cochrane Library, CINHAL Plus, Web of Science, PsycINFO, PSYNDEX, the Francine Shapiro Library, and citations of original studies and reviews. All studies using EMDR for treating chronic pain were eligible for inclusion in the present study. The main outcomes were pain intensity, disability, and negative mood (depression and anxiety). The effects were described as standardized mean differences. Results Two controlled trials with a total of 80 subjects and 10 observational studies with 116 subjects met the inclusion criteria. All of these studies assessed pain intensity. In addition, five studies measured disability, eight studies depression, and five studies anxiety. Controlled trials demonstrated significant improvements in pain intensity with high effect sizes (Hedges' g: −6.87 [95% confidence interval (CI95): −8.51, −5.23] and −1.12 [CI95: −1.82, −0.42]). The pretreatment/posttreatment effect size calculations of the observational studies revealed that the effect sizes varied considerably, ranging from Hedges' g values of −0.24 (CI95: −0.88, 0.40) to −5.86 (CI95: −10.12, −1.60) for reductions in pain intensity, −0.34 (CI95: −1.27, 0.59) to −3.69 (CI95: −24.66, 17.28) for improvements in disability, −0.57 (CI95: −1.47, 0.32) to −1.47 (CI95: −3.18, 0.25) for improvements in depressive symptoms, and −0.59 (CI95: −1.05, 0.13) to −1.10 (CI95: −2.68, 0.48) for anxiety. Follow-up assessments showed maintained improvements. No adverse events were reported. Conclusions Although the results of our study suggest that EMDR may be a safe and promising treatment option in chronic pain conditions, the small number of high-quality studies leads to insufficient evidence for definite treatment recommendations.

Findings considering conditioned pain modulation (CPM) in chronic back pain (CBP) are contradictory. This might be because many patients with CBP report pain in further areas of the body, and altered CPM might influence spatial extent of pain rather than CBP per se. Therefore, we compared CPM in patients with CBP with different pain extent. Patients with fibromyalgia syndrome (FMS), for whom CPM impairment is reported most consistently, were measured for comparison. Based on clinical evaluation and pain drawings, patients were categorized into chronic local back pain (CLP; n = 53), chronic widespread back pain (CWP; n = 32), and FMS (n = 92). Conditioned pain modulation was measured by the difference in pressure pain threshold (test stimuli) at the lower back before and after tonic heat pain (conditioning stimulus). We also measured psychosocial variables. Pressure pain threshold was significantly increased in CLP patients after tonic heat pain (P < 0.001) indicating induction of CPM. Conditioned pain modulation in CLP was significantly higher than that in CWP and FMS (P < 0.001), but CPM in CWP and FMS did not differ. Interestingly, a higher number of painful areas (0-10) were associated with lower CPM (r = 0.346, P = 0.001) in CBP but not in FMS (r = -0.013, P = 0.903). Anxiety and depression were more pronounced in FMS than in CLP or CWP (P values

BACKGROUND The scheduled update to the German S3 guidelines on fibromyalgia syndrome (FMS) by the Association of the Scientific Medical Societies ("Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften", AWMF; registration number 041/004) was planned starting in March 2011. MATERIALS AND METHODS The development of the guidelines was coordinated by the German Interdisciplinary Association for Pain Therapy ("Deutsche Interdisziplinaren Vereinigung fur Schmerztherapie", DIVS), 9 scientific medical societies and 2 patient self-help organizations. Eight working groups with a total of 50 members were evenly balanced in terms of gender, medical field, potential conflicts of interest and hierarchical position in the medical and scientific fields. Literature searches were performed using the Medline, PsycInfo, Scopus and Cochrane Library databases (until December 2010). The grading of the strength of the evidence followed the scheme of the Oxford Centre for Evidence-Based Medicine. The formulation and grading of recommendations was accomplished using a multi-step, formal consensus process. The guidelines were reviewed by the boards of the participating scientific medical societies. RESULTS AND CONCLUSION The clinical diagnosis of FMS can be established by the American College of Rheumatology (ACR) 1990 classification criteria (with tender point examination), by the modified preliminary diagnostic ACR 2010 criteria or by the diagnostic criteria of the German interdisciplinary guideline (AWMF) on FMS. The English full-text version of this article is available at SpringerLink (under "Supplemental").

Objective Fibromyalgia syndrome (FMS) is a condition of chronic widespread pain that is difficult to control and is associated with strains in physician–patient interaction. Shared decision making (SDM) can be a potential solution to improve interaction. We evaluated the effects of an SDM intervention, including an SDM communication training program for physicians, in a randomized controlled trial with FMS patients. The main objective was to assess whether SDM improves the quality of physician–patient interaction from patients' perspective. Methods Patients were randomized to either an SDM group or an information-only group. The SDM group was treated by physicians trained in SDM communication and had access to a computer-based information package; the information-only group received only the information package and was treated by standard physicians. All patients were offered the same evidence-based treatment options for FMS. Patients were assessed with questionnaires on physician–patient interaction (main outcome criteria) and decisional processes. Physicians filled out a questionnaire on interaction difficulties. Assessment took place immediately after the initial consultation. Results Data from 85 FMS patients (44 in the SDM group and 41 in the information-only group) were analyzed. The mean age was 49.9 years (S.D.=10.2), and 91.8% of patients were female. The quality of physician–patient interaction was significantly higher in the SDM group than in the information-only group (P

Whether chronic localized pain (CLP) and chronic widespread pain (CWP) have different mechanisms or to what extent they overlap in their pathophysiology is controversial. The study compared quantitative sensory testing profiles of nonspecific chronic back pain patients with CLP (n=48) and CWP (n=29) with and fibromyalgia syndrome (FMS) patients (n=90) and pain-free controls (n = 40).The quantitative sensory testing protocol of the "German-Research-Network-on-Neuropathic-Pain" was used to measure evoked pain on the painful area in the lower back and the pain-free hand (thermal and mechanical detection and pain thresholds, vibration threshold, pain sensitivity to sharp and blunt mechanical stimuli). Ongoing pain and psychometrics were captured with pain drawings and questionnaires.CLP patients did not differ from pain-free controls, except for lower pressure pain threshold (PPT) on the back. CWP and FMS patients showed lower heat pain threshold and higher wind-up ratio on the back and lower heat pain threshold and cold pain threshold on the hand. FMS showed lower PPT on back and hand, and higher comorbidity of anxiety and depression and more functional impairment than all other groups.Even after long duration CLP presents with a local hypersensitivity for PPT, suggesting a somatotopically specific sensitization of nociceptive processing. However, CWP patients show widespread ongoing pain and hyperalgesia for different stimuli that is generalized in space, suggesting the involvement of descending control systems, as also suggested for FMS patients. Because mechanisms in nonspecific chronic back pain with CLP and CWP differ, these patients should be distinguished in future research and allocated to different treatments.

Objective Fibromyalgia syndrome (FMS) patients and their doctors frequently complain on interaction difficulties. We investigated the effects of a shared decision-making (SDM) intervention on physician–patient interaction and health outcome. Methods Sixty-seven FMS patients of an outpatient university setting that had been included in a randomized controlled trial were followed up. They were either treated in an SDM group or in an information group. Both groups saw a computer based information tool on FMS, but only the SDM group was treated by doctors which underwent a special SDM communication training. A comparison group of 44 FMS patients receiving treatment as usual was recruited in rheumatological practices. We assessed patients and their doctors using a combined qualitative and quantitative approach. Patients and doctors were followed-up after 3 months (T2) and after 1 year (T3). Results The significantly best quality of physician–patient interaction was reported by patients and doctors of the SDM group, followed by the information group. Coping had more often improved in the SDM group than in the information group. However directly health related outcome variables had not improved in any of the groups at T3. Conclusion An SDM intervention can lead to an improved physician–patient relationship from the patients’ and from the doctors’ perspective. Practice implications It should be considered to include SDM in standard care for FMS patients.

Objective Assessment of the use of a computerized information-tool in the context of a shared decision-making process with chronic pain patients. Methods In the scope of a prospective and randomized study on shared decision-making with Fibromyalgia patients, a total of 75 patients had access to computer-based information about their illness. Fibromyalgia is a condition of chronic wide-spread pain, belonging to rheumatism, which mainly affects mature female patients. The majority of the patients in our study are female (93%) with an average age of 50 years. The computer-based information-tool provided the patients with detailed information about pathogenesis, typical symptoms, treatment options and prognosis. Six evaluative questions were posed to the participants concerning the assessment of the information presented, the handling of the programme, the need for an introduction to the programme, the quality of the layout and the assessment of the length of time spent in front of the computer and the assessment of the usefulness of such a tool in general practitioners’ offices. Furthermore, psychological self-assessment questionnaires were filled out by the participants. Results The patients highly appreciate the possibility of using computer-based information-tools and endorse the implementation of such tools in general practitioners’ offices. Conclusion Computerized information leads to a better understanding of the illness and the treatment options on the part of the patient. Practical implications For further practical use it is crucial to provide an introduction to the handling of a computer to unskilled patients.

Fibromyalgia syndrome (FMS) is an exemplary condition of chronic widespread pain that is difficult to control and often leads to frustration and resignation on the part of both the patient and the doctor. Shared decision making (SDM) could be a means to facilitate doctor-patient interaction and might therefore influence therapeutic decisions taken. We conducted a prospective study to evaluate the effects of SDM with FMS patients. We developed a communication train-ing program for physicians and a computer-based information tool on FMS for patients. The study included 133 FMS patients. Intervention group I (IG I) was treated by communication-trained doctors and had access to a computer-based information tool on FMS,intervention group II (IG II) was treated by standard doctors and received the information tool, and the control group (CG) was treated by standard doctors and got no additional information. All three groups we-re offered the same evidence-based treatment options for FMS. Patients of the IGs were more willing to become involved in exercise, to enroll in integrated group therapy for FMS patients (IGTF), and to take analgesics. Patients of the CG preferred anti-depressants. More patients from IG II and CG opted for relaxation techniques. Patients in IG I and IG II choose significantly more therapeutic options than patients in the CG. SDM is one means to increase FMS patients' readiness for treatment. Especially the element of providing sufficient medical information seems to account for this effect. The readiness to enroll in physical activities, to take analgesics, and to participate in psychotherapeutic elements was most likely to be raised through SDM.

OBJECTIVE: To determine the relative contribution of psychiatric comorbidity to work disability in patients with inflammatory rheumatic diseases (IRD). Parallel analyses were also performed in a matched control group with no diagnosis of IRD to investigate if predictors of work disability in medical patients are independent from the presence of IRD. METHOD: The patient group with IRD (73.9% female; mean age, 42.7 years) and the control group (73.9% female; mean age, 42.2 years) consisted of 356 outpatients each. Psychiatric comorbidity was diagnosed using the Patient Health Questionnaire (PHQ), functional disability was measured with the 12-item Short-Form Health Survey (SF-12), and severity of illness was assessed by the treating physicians. Stepwise logistic regression analyses were performed to identify independent predictors of work disability controlling for psychiatric comorbidity, functional disability, severity of illness, additional clinical variables, and demographics. RESULTS: Psychiatric comorbidity increased work disability in patients with severe IRD from 25% to 50%, and from 5% to 17% in mild disease. Physical functioning (OR = 0.6; p

Psychosocial factors influence the course and the outcome of chronic somatic diseases. This is also valid for rheumatic diseases like rheumatoid arthritis, spondyloarthropathies, systemic collagen vascular diseases, and fibromyalgia syndrome. The article summarises the evidence-based findings and it illustrates possibilities of psychosomatic treatment in rheumatic diseases by means of three case reports.

This short-term study examined the effectiveness of the Feldenkrais method of functional integration and of progressive muscle relaxation (PMR) compared with the standard medical treatment during the acute phase after myocardial infarction. Three patient groups (n = 20 each) received 1 of 3 treatment options: 2 sessions of Feldenkrais therapy, 2 sessions of PMR, or no intervention. Evaluations using quantitative and qualitative methods were performed an average of 3.7 and 7.8 days after subjects' myocardial infarction, respectively. Significant improvements, independent of the intervention, were found over the evaluation period in the Perception of Body Dynamics body image scale and in the Physical Well-Being and Emotional Well-Being quality-of-life scales. A statistically significant, differential effect of any one intervention with respect to the control group did not arise in any of the quantitative questionnaire variables examined. However, subjective improvements of varying description were noted by ...

Objectives: The focus of this review was on proteins and peptides found in saliva. Of greatest interest were those neuropeptides relevant to nociception and to the pathogenesis of chronic pain syndromes. An additional goal was to develop a standardized protocol to collect saliva for laboratory assessment. Methods: Data were obtained through discussion with experts at the medical schools in San Antonio and Heidelberg and a Medline literature search involving all relevant studies from 1966 to 1997. The literature search was based on the following key terms: saliva, serotonin, neuropeptide, substance P (SP), calcitonin gene-related peptide (CGRP), and nerve growth factor (NGF). Results: The mean concentration of SP in the saliva of healthy normal controls ranged from 9.6 to 220 pg/mL. Generally, the concentration of SP was approximately three times higher in saliva than in plasma. In a number of painful conditions, particularly tension headache, substantial elevations of salivary SP were found. Mean values for salivary CGRP in healthy controls were approximately 22 pmol/L and were significantly elevated in patients with migraine attacks or cluster headache. There were no data to indicate prior quantitative determination of NGF in human saliva. Conclusions: After sampling and processing techniques have been standardized,measurement of neuropeptides in human saliva could provide a valuable tool for the study of patients with chronic painful disorders such as rheumatoid arthritis, osteoarthritis, and even fibromyalgia syndrome.

Age- and gender-matched reference values are essential for the clinical use of quantitative sensory testing (QST). To extend the standard test sites for QST-according to the German Research Network on Neuropathic Pain-to the trunk, we collected QST profiles on the back in 162 healthy subjects. Sensory profiles for standard test sites were within normal interlaboratory differences. QST revealed lower sensitivity on the upper back than the hand, and higher sensitivity on the lower back than the foot, but no systematic differences between these trunk sites. Age effects were significant for most parameters. Females exhibited lower pressure pain thresholds (PPT) than males, which was the only significant gender difference. Values outside the 95% confidence interval of healthy subjects (considered abnormal) required temperature changes of >3.3-8.2 °C for thermal detection. For cold pain thresholds, confidence intervals extended mostly beyond safety cutoffs, hence only relative reference data (left-right differences, hand-trunk differences) were sufficiently sensitive. For mechanical detection and pain thresholds, left-right differences were 1.5-2.3 times more sensitive than absolute reference data. The most sensitive parameter was PPT, where already side-to-side differences >35% were abnormal. Compared to trunk reference data, patients with postherpetic neuralgia exhibited thermal and tactile deficits and dynamic mechanical allodynia, mostly without reduced mechanical pain thresholds. This pattern deviates from other types of neuropathic pain. QST reference data for the trunk will also be useful for patients with postthoracotomy pain or chronic back pain.

Objective. To investigate the prevalence and the type of mental comorbidity in a population-based sample of subjects with non-specific chronic back pain. Design. Representative population-based survey. Setting. The city of Heidelberg (in southwestern Germany) and 10 adjacent communities. Patients. From a random sample of individuals (N = 2,000), 1,091 subjects completed a questionnaire including a pain assessment. Of those, 188 subjects (17%) fulfilled the criteria for chronic back pain (≥45 days of back pain in the last 3 months) and were subsequently invited to undergo a detailed clinical examination; 131 subjects (70%) agreed to participate. The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (SCID-I + II) was used to assess current (defined as the previous 4 weeks) mental comorbidity and was completed in 110 subjects (84%) with non-specific chronic back pain. Intervention. N/A. Outcome Measures. DSM-IV mental comorbidity diagnoses. Results. The overall prevalence of mental comorbidity of Axis-I and -II disorders were 35.5% and 15.5%, respectively. Of Axis-I disorders, anxiety disorders (20.9%) and affective disorders (12.7%) were the most frequent. Of Axis-II disorders, 9.1% of diagnoses was of the Cluster C category (anxious/inhibited). Compared with the general population, the total rate of Axis-I comorbidity was significantly higher, while the total rate for Axis-II personality disorders was only slightly different. Conclusions. The consistent diagnoses of anxiety, fear, and avoidance in these subjects indicate that also primary care health professionals should consider anxiety disorders in patients with chronic pain, in addition to the affective disorders that are most frequently self-reported in pain patients.

Alterations in the central nervous system leading to higher pain sensitivity have been shown in both chronic back pain (CBP) and fibromyalgia syndrome (FMS). The aim of this study was to disclose commonalities and differences in the pathophysiology of FMS and CBP.We used the quantitative sensory testing protocol of the German Research Network on Neuropathic Pain to obtain comprehensive profiles of somatosensory functions. The protocol comprised thermal and mechanical detection and pain thresholds, vibration thresholds, and pain sensitivity to sharp and blunt mechanical stimuli. We studied 21 FMS patients (mean pain duration: 13.4 y), 23 CBP subjects (mean pain duration: 15.9 y), and 20 healthy controls (HCs). Each participant received the test battery on the back and on the dorsal hand (pain-free control site).On the back, FMS patients showed increased thermal and mechanical pain sensitivity compared with HCs and CBP participants. On the hand dorsum, FMS patients showed higher mechanical pain sensitivity compared with CBP participants and HCs and higher cold pain sensitivity compared with HCs. CBP participants showed increased pressure pain sensitivity and lower vibration sensitivity on the back, but no significant differences on the hand dorsum compared with HCs.FMS patients showed increased sensitivity for different pain modalities at all measured body areas, suggesting central disinhibition as a potential mechanism. CBP participants in contrast, showed localized alterations within the affected segment possibly due to peripheral sensitization.

Objective To assess the efficacy and safety of terguride, a partial dopamine agonist, in patients with fibromyalgia syndrome (FMS). Methods In a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, 99 patients were randomized at a ratio of 2 to 1 to receive terguride or placebo. Over 21 days, the dosage was titrated to a maximum daily dose of 3 mg of terguride or placebo, and this fixed dosage was continued over 9 weeks. The primary efficacy variable was the intensity of pain (100-mm visual analog scale). Secondary efficacy variables included the Fibromyalgia Impact Questionnaire (FIQ) score, the tender point score (TPS), and the Hamilton Depression Scale (HDS) score. During the study, patients were evaluated for the presence of cervical spine stenosis by magnetic resonance imaging (MRI). Results No significant differences in the change in pain intensity, FIQ score, TPS, or HDS score between baseline and 12 weeks were observed in the terguride group as compared with the placebo group. Cervical spine stenosis was detected in 22% of the patients. Only patients with cervical spine stenosis responded to terguride treatment. FIQ scores improved significantly (per-protocol analysis), and pain intensity, the TPS score, and the HDS score showed a trend toward improvement in the terguride group as compared with the placebo group. Terguride treatment was safe. Only those adverse events already known to be side effects of terguride were observed. Premature termination of the study in patients receiving terguride (26%) occurred predominantly during up-titration and in the absence of comedication for treatment of nausea. Conclusion Terguride treatment did not improve pain, the FIQ score, the TPS, or the HDS score in the total study population. However, a subgroup of patients with cervical spine stenosis seemed to benefit from terguride treatment.

Background and aims Longitudinal population studies are a keystone in describing the course of back pain over time. Yet, potential bias because of repeated attrition has received little attention. This study aims to identify those back pain related indicators most susceptible to bias and to discuss practical consequences for back pain research. Methods Analyses were based on a population-based longitudinal multi-centre postal back pain survey with two postal follow-up measurements within 2 years. The baseline sample comprised 9263 subjects. Different sets of measures at entry were used to predict subsequent attrition: Socio-demographic variables, indicators of back pain, health related measures, and response behaviour. Back pain related indicators comprised prevalence estimates, pain intensity, disability, and radiating pain. Weighted and unweighted back pain outcomes were compared at the first and second follow-up to assess bias. Results Only 52.3% of the eligible participants at baseline continued participation till the second follow-up. Age and prior response behaviour were the best predictors of attrition while health and back pain related variables were of less importance. Differences between weighted and unweighted estimates of back pain related indicators were small to negligible, thus indicating little bias in point estimates. Unexpectedly, the reported back pain burden slightly declined over time. Conclusion The representativeness of the sample is consecutively reduced because of differential attrition over the different measurement points. Despite this, bias due to attrition has a marginal impact on the point estimates of virtually all back pain related outcomes.

According to population-based studies, the estimated prevalence of chronic widespread pain (CWP) is 7% to 11%, and that of the fibromyalgia syndrome (FMS) is 1% to 5% (1). Patients often suffer considerable distress from their condition as well as an impairment of their health-related quality of life, resulting in considerable direct and indirect costs of illness (1, e1). Patients and treating physicians alike are often disappointed by the results of treatment (2). The classification and treatment of this symptom complex are controversial matters, not only within and among the medical specialty societies, but also among patients and their families. Many rheumatologists, neurologists, and pain specialists, as well as many patients, consider fibromyalgia syndrome (FMS) to be a distinct illness associated with pathological changes in the muscles and connective tissue and with characteristic functional abnormalities of the central nervous system (e2, e3). In keeping with this neurobiological conception, the European League Against Rheumatism (EULAR), an expert committee composed mainly of rheumatologists, gives its highest-level therapeutic recommendation exclusively to treatment with medications (3). Many specialists in psychosomatic medicine, on the other hand, conceptualize the FMS symptom complex as a type of somatoform disorder (e4), while many psychiatrists see it as a type of affective disorder (e5). These specialists assert that the inappropriate "medicalization of misery" (e6) as a rheumatological disease construct implies that some sort of non-demonstrable rheumatic process exists in the muscles and connective tissue and is responsible for the condition. The psychosomatic conception of FMS leads to a recommendation for treatment with psychotherapy (e7), while the psychiatric conception leads to a recommendation for treatment with psychotropic medications (e8). Many patients reject a reduction of this condition to purely somatic causes. In view of the controversy about this symptom complex and its unquestioned importance as a public health problem, the time has certainly come for a German interdisciplinary guideline to be issued by a collaboration of all of the specialty societies involved in the treatment of this condition, together with patient representatives (4). This article is intended to inform the reader about the guideline’s position on controversial questions as to the classification, diagnosis, and treatment of the fibromyalgia syndrome.

Objective: The main objective of this review was to evaluate the role of psychosocial factors in the development of fibromyalgia syndrome. Method: Review of the literature concerning the influence of psychosocial factors. Results: In fibromyalgia syndrome psychosocial factors are relevant at different etiological levels. They can be classified into predisposing, triggering and stabilising/“chronifying” factors. Conclusion: Due to the increasing knowledge about the influence of psychosocial factors for the development of fibromyalgia, the biomedical model has to be expanded to a biopsychosocial model. The biopsychosocial concept has an impact on the therapeutic approach. Strong evidence for the model is provided by the good results of interdisciplinary treatment studies.

Background Pain conditions of the musculoskeletal system are very common and have tremendous socioeconomic impact. Despite its high prevalence, musculoskeletal pain remains poorly understood and predominantly non-specifically and insufficiently treated. The group of chronic musculoskeletal pain patients is supposed to be heterogeneous, due to a multitude of mechanisms involved in chronic pain. Psychological variables, psychophysiological processes, and neuroendocrine alterations are expected to be involved. Thus far, studies on musculoskeletal pain have predominantly focused on the general aspects of pain processing, thus neglecting the heterogeneity of patients with musculoskeletal pain. Consequently, there is a need for studies that comprise a multitude of mechanisms that are potentially involved in the chronicity and spread of pain. This need might foster research and facilitate a better pathophysiological understanding of the condition, thereby promoting the development of specific mechanism-based treatments for chronic pain. Therefore, the objectives of this study are as follows: 1) identify and describe subgroups of patients with musculoskeletal pain with regard to clinical manifestations (including mental co-morbidity) and 2) investigate whether distinct sensory profiles or 3) distinct plasma levels of pain-related parameters due to different underlying mechanisms can be distinguished in various subgroups of pain patients. Methods/Design We will examine a population-based chronic pain sample (n = 100), a clinical tertiary care sample (n = 100) and pain-free patients with depression or post-traumatic stress disorder and pain-free healthy controls (each n = 30, respectively). The samples will be pain localisation matched by sex and age to the population-based sample. Patients will undergo physical examination and thorough assessments of mental co-morbidity (including psychological trauma), perceptual and central sensitisation (quantitative sensory testing), descending inhibition (conditioned pain modulation, the diffuse noxious inhibitory control-like effect), as well as measurement of the plasma levels of nerve growth factor and endocannabinoids. Discussion The identification of the underlying pathophysiologic mechanisms in different subgroups of chronic musculoskeletal pain patients will contribute to a mechanism-based subgroup classification. This will foster the development of mechanism-based treatments and holds promise to treat patients more sufficient.

Non-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient. Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma. Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone. The study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n = 20) or a control group (n = 20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later. The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0–10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment. In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed. The statistical analysis of the primary outcome will be performed on an intention-to-treat basis. The secondary outcomes will be analyzed in an explorative, descriptive manner. This study adapts the standard EMDR treatment for traumatized patients to patients with CBP who have experienced psychological trauma. This specific, mechanism-based approach might benefit patients. This trial has been registered with ClinicalTrials.gov ( NCT01850875 ).