The PerPAIN trial: a pilot randomized controlled trial of personalized treatment allocation for chronic musculoskeletal pain-a protocol.

BACKGROUND: The therapy of chronic musculoskeletal pain (CMSP) is complex and the treatment results are often insufficient despite numerous therapeutic options. While individual patients respond very well to specific interventions, other patients show no improvement. Personalized treatment assignment offers a promising approach to improve response rates; however, there are no validated cross-disease allocation algorithms available for the treatment of chronic pain in validated personalized pain interventions. This trial aims to test the feasibility and safety of a personalized pain psychotherapy allocation with three different treatment modules and estimate initial signals of efficacy and utility of such an approach compared to non-personalized allocation. METHODS: This is a randomized, controlled assessor-blinded pilot trial with a multifactorial parallel arm design. CMSP patients (n = 105) will be randomly assigned 1:1 to personalized or non-personalized treatment based on a cluster assignment of the West Haven-Yale Multidimensional Pain Inventory (MPI). In the personalized assignment condition, patients with high levels of distress receive an emotional distress-tailored intervention, patients with pain-related interference receive an exposure/extinction-tailored treatment intervention and patients who adapt relatively well to the pain receive a low-level smartphone-based activity diary intervention. In the control arm, patients receive one of the two non-matching interventions. Effect sizes will be calculated for change in core pain outcome domains (pain intensity, physical and emotional functioning, stress experience, participant ratings of improvement and satisfaction) after intervention and at follow-up. Feasibility and safety outcomes will assess rates of recruitment, retention, adherence and adverse events. Additional data on neurobiological and psychological characteristics of the patients are collected to improve treatment allocation in future studies. CONCLUSION: Although the call for personalized treatment approaches is widely discussed, randomized controlled trials are lacking. As the personalization of treatment approaches is challenging, both allocation and intervention need to be dynamically coordinated. This study will test the feasibility and safety of a novel study design in order to provide a methodological framework for future multicentre RCTs for personalized pain psychotherapy. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00022792 ( https://www.drks.de ). Prospectively registered on 04/06/2021.

[Influence of early childhood stress exposure and traumatic life events on pain perception]. / Einfluss frühkindlicher Stresserfahrungen und traumatisierender Lebensereignisse auf das Schmerzempfinden.

Adult pain perception is influenced substantially by interactions between mind, body, and social environment during early life. Early stress exposure and traumatic life events induce powerful psychophysical stress reactions that exert multiple neurofunctional processes. This has significant implications for pain perception and pain processing. As part of this review, the complex relationships between traumatic stress experiences and associated psychobiological mechanisms of chronic pain will be discussed. Based on selected studies, psychophysiological findings are presented and possible underlying mechanisms are discussed. The article concludes with a discussion of potential implications for treatment.

[Shared Decision Making (SDM) - Patient and Physician as a Team]. / Partizipative Entscheidungsfindung (PEF) ­ Patient und Arzt als Team.

The article provides an overview on Shared Decision Making (SDM), which is considered as the ideal form of physician-patient-interaction by many stakeholders of the health care system. SDM is distinguished from other models of physician-patient-interaction such as the paternalistic model and the information model. Besides the degree of acceptance of SDM in the general population and among physicians, barriers for its implementation will be reported. Indications for SDM as well as strategies and support material for its use in individual consultations will be discussed and illustrated by an oncological case study. Effects of SDM for patients as well as for clinicians will be highlighted. After background information on origins of SDM, its significance with regard to health policy in Germany is discussed.

[Definition, classification, clinical diagnosis and prognosis of fibromyalgia syndrome : Updated guidelines 2017 and overview of systematic review articles]. / Definition, Klassifikation, klinische Diagnose und Prognose des Fibromyalgiesyndroms : Aktualisierte Leitlinie 2017 und Übersicht von systematischen Übersichtsarbeiten.

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 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. The guidelines were reviewed and approved by the board of directors of the societies engaged in the development of the guidelines. RESULTS AND CONCLUSION: The clinical diagnosis of fibromyalgia syndrome can be established by the American College of Rheumatology (ACR) 1990 classification criteria (with examination of tender points) or without the examination of tender points by the modified preliminary diagnostic ACR 2010 or 2011 criteria.

[Childhood abuse experiences and chronic low back pain. Direct and mediated effects of childhood abuse in different pain dimensions of nonspecific chronic low back pain]. / Frühe Missbrauchserlebnisse bei chronischem Kreuzschmerz. Direkte und mediierte Effekte früher Missbrauchserlebnisse auf verschiedene Schmerzdimensionen chronischer nichtspezifischer Kreuzschmerzen.

BACKGROUND: Physical, sexual and emotional abuse in childhood and adolescence is considered to play a role in the etiology and generalization of chronic pain in adulthood. However, it remains unclear whether abuse is specifically associated with different dimensions of nonspecific chronic low back pain (CLBP) and if these associations are mediated by psychological symptoms. MATERIAL AND METHODS: A total of 103 patients with validated CLBP were assessed by pain drawing, the multidimensional pain questionnaire and the pain experience scale. The childhood trauma questionnaire was used to retrospectively screen for physical, sexual and emotional abuse in childhood and adolescence. Patients were also screened for symptoms of depression, anxiety and dissociation in order to look for possible mediators. RESULTS: Patients with CLBP who reported childhood abuse showed higher pain intensity, higher spatial extent of pain, higher affective and sensory pain sensation and more pain disability compared to CLBP patients who had not experienced abuse. However, multivariate analyses revealed that only the spatial extent of pain was directly associated with childhood abuse. Furthermore, a significant association between childhood abuse and sensory pain sensation was found to be mediated by symptoms of anxiety and dissociation. CONCLUSION: The influence of childhood abuse on CLBP is different for specific pain dimensions; therefore, CLBP should be faced as a complex construct that comprises different dimensions. Childhood abuse is suggested as a risk factor for spreading pain in CLBP persons; therefore, CLBP patients reporting additional pain locations might benefit from diagnostic and therapeutic interventions specific for childhood abuse experiences.

[Fibromyalgia syndrome. Definition, classification, clinical diagnosis and prognosis]. / Das Fibromyalgiesyndrom. Definition, Klassifikation, klinische Diagnose und Prognose.

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 Interdisziplinären Vereinigung für 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").

[Fibromyalgia syndrome. General principles and coordination of clinical care and patient education]. / Das Fibromyalgiesyndrom. Allgemeine Behandlungsgrundsätze, Versorgungskoordination und Patientenschulung.

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 Interdisziplinären Vereinigung für 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: A diagnosis of FMS should be explicitly communicated with the afflicted individual. A step-wise treatment, depending on the severity of FMS and the responses to therapeutic measures, is recommended. Therapy should only be continued if the positive effects outweigh the side effects. The English full-text version of this article is available at SpringerLink (under "Supplemental").

[Definition, classification and diagnosis of fibromyalgia syndrome]. / Definition, Klassifikation und Diagnose des Fibromyalgiesyndroms.

BACKGROUND: Interdisciplinary guidelines for the definition, classification and diagnosis of chronic widespread pain (CWP) and fibromyalgia syndrome (FMS) were developed by collaboration of 10 German medical and psychological associations and 2 patient self-help organizations. METHODS: A systematic literature search was performed in the Cochrane Library (1993-12/2006). Medline (1980-2006), and Scopus (1980-12/2006). Levels of evidence were assigned according to the classification system of the Oxford Center for Evidence-Based Medicine. Grading of the strength of recommendation was done according to the German program for disease management guidelines. Standardized procedures to reach a consensus on recommendations were used. RESULTS: CWP is defined by the criteria of the American College of Rheumatology (ACR-strong consensus). FMS can be diagnosed for clinical purposes by symptom-based criteria (without tender point examination) as well as by the ACR criteria (strong consensus).

[Principles of treatment, coordination of medical care and patient education in fibromyalgia syndrome and chronic widespread pain]. / Allgemeine Behandlungsgrundsätze, Versorgungskoordination und Patientenschulung beim Fibromyalgiesyndrom und chronischen Schmerzen in mehreren Körperregionen.

BACKGROUND: A guideline for the treatment and diagnostic procedures for fibromyalgia syndrome (FMS) was developed in cooperation with 10 German medical and psychological associations and 2 patient self-help groups. METHODS: A systematic literature search including all controlled studies evaluating physiotherapy, exercise and strength training as well as physical therapies was performed in the Cochrane Collaboration Reviews (1993-12/2006), Medline (1980-12/2006), PsychInfo (1966-12/2006) and Scopus (1980-12/2006). Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine. Grading of the strengths of recommendations was done according to the German program for disease management guidelines. Standardized procedures to reach a consensus on recommendations were used. RESULTS: Patient's information at first diagnosis of FMS is strongly recommended (grade A). Patient-centered communication is recommended (grade B). A stepwise treatment approach depending on the adapatation to restrictions in daily life and response to treatment options can be considered (grade C). CONCLUSIONS: The long-term treatment should be based on principles of basic psychosomatic care and shared decision making on treatment options.

[Definition, classification and diagnosis of fibromyalgia syndrome]. / Definition, klassifikation und diagnose des fibromyalgiesyndroms.

BACKGROUND: Interdisciplinary guidelines for the definition, classification and diagnosis of chronic widespread pain (CWP) and fibromyalgia syndrome (FMS) were developed by collaboration of 10 German medical and psychological associations and 2 patient self-help organizations. METHODS: A systematic literature search was performed in the Cochrane Library (1993-12/2006), Medline (1980-2006), PsychInfo (1966-12/2006), and Scopus (1980-12/2006). Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine. Grading of the strength of recommendation was done according to the German program for disease management guidelines. Standardized procedures to reach a consensus on recommendations were used. RESULTS: CWP is defined by the criteria of the American College of Rheumatology (ACR--strong consensus). FMS can be diagnosed for clinical purposes by symptom-based criteria (without tender point examination) as well as by the ACR criteria (strong consensus).

[Aims of the guidelines for diagnostic and treatment of fibromyalgia syndrome]. / Ziele der leitlinie zur diagnostik und therapie des fibromyalgiesyndroms.

The guidelines aim to provide all professions involved in the treatment of fibromyalgia syndrome (FMS) a systematically developed basis for the diagnosis and therapy of FMS. Diagnostic criteria and empirically founded therapies are presented to reduce the currently insufficient medical care for FMS patients. Recommendations for a stepwise therapeutic approach are designed to improve the quality of medical care, the implementation of effective treatment options as well as reduction of the utilization of non-effective therapies and improvement of the patient-physician relationship. Recommendations on the coordination of medical care (inpatient and outpatient treatment by family physicians, medical specialists and other medical professions, care in emergency and rehabilitation hospitals) aim to reduce rivalry between medical societies and to promote an optimal use of resources. A patient version of the guidelines is aimed at improving patients' knowledge on the etiology and effective treatment options available thus promoting an effective self-management of patients.

Using interaction graphs for analysing the therapy process.

BACKGROUND: Therapy processes are complex dynamical systems where several variables are constantly interacting with each other. In general, the underlying mechanisms are difficult to assess. Our approach is to identify the dependency structure of relevant variables within the therapy process using interaction graphs. These are instruments for multivariate time series which are based on the analysis of partial spectral coherences. We used interaction graphs in order to investigate the therapy process of a multimodal therapy concept for fibromyalgia patients. Our main hypothesis was that self-efficacy plays a central role in the therapy process. METHODS: Patients kept an electronic diary for 13 weeks. Pain intensity, depression, sleep quality, anxiety and self-efficacy were assessed via visual analogue scales. The resulting multivariate time series were aggregated over individuals, and partial spectral coherences between each pair of the variables were calculated. From the partial coherences, interaction graphs were plotted. RESULTS: Within the resulting graphical model, self-efficacy was strongly related to pain intensity, depression and sleep quality. All other relations were substantially weaker. There was no direct relationship between pain intensity and sleep quality. CONCLUSIONS: The relations between two variables within the therapy process are mainly induced by self-efficacy. Interaction graphs can be used to pool time series data of several patients and thus to assess the common underlying dependency structure of a group of patients. The graphical representation is easily comprehensible and allows to distinguish between direct and indirect relationships.

[Stress and autonomic dysregulation in patients with fibromyalgia syndrome]. / Stress und autonome Dysregulation bei Patienten mit einem Fibromyalgiesyndrom.

AIM: The aim of the present study was to evaluate to what extent the orthostatic dysregulation of FMS patients can be attributed primarily to reduced baroreceptor-mediated activation of the sympathetic nervous system and whether a hyporeactive sympathetic nervous system can also be confirmed for mental stress. PATIENTS AND METHODS: A total of 28 patients with primary FMS were examined and compared with 15 healthy subjects. Diagnostic investigations of the autonomic nervous system were based on measuring HRV in frequency range and assessing spontaneous baroreflex sensitivity (sBRS) under mental stress and passive orthostatism. RESULTS: Both under orthostatic and mental stress FMS patients exhibited reduced activation of the sympathetic nervous system as measured by the spectral power of HRV in the low-frequency range and the mean arterial blood pressure or heart rate. The present study provided no indications for dysregulation of sBRS. CONCLUSION: The results obtained confirm the hypothesis of a hyporeactive stress system in FMS patients for both peripherally and centrally mediated stimulation of the sympathetic nervous system.

[Shared decision making (SDM) with chronic pain patients. The patient as a partner in the medical decision making process]. / Partizipative Entscheidungsfindung (PEF) mit chronischen Schmerzpatienten. Der Patient als Partner im medizinischen Entscheidungsprozess.

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.

[Development and validation of assessment instruments for shared decision making]. / Entwicklung eines Fragebogens zur Partizipativen Entscheidungsfindung.

The German Ministry for Health and Social Security is funding ten projects to introduce shared decision making into clinical practice. The medical problems the projects are focussing on were chosen from among various diseases (e. g. depression, multiple sclerosis, cancer). The ten projects achieved consensus on a core set of instruments for the measurement of process and outcome of the shared decision making. Instruments developed in German-speaking countries are currently not available. Thus, linguistic and cultural validation had to be performed for the core set instruments. The results of the data analysis as well as patient interviews demonstrate the need for improving these instruments. Therefore, the members of the methodological working group concentrated on the integration of these results in a new instrument. In a first step the construct of "shared decision making" was defined, followed by a definition of the process elements characterising shared decision making. Thereafter, items were developed on the basis of the process elements. The new instrument will now be validated for different diseases.

[Psychosomatics in rheumatology]. / Psychosomatik in der Rheumatologie.

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.

[Psychosocial factors in a fibromyalgia syndrome patient. Assessment by means of electron pain diaries--casuistics and multivariate time series analysis]. / Psychosoziale Faktoren bei einer Fibromyalgiepatientin. Erfassung mittels eines elektronischen Schmerztagebuchs-Kasuistik und multivariate Zeitreihenanalyse.

OBJECTIVE: Fibromyalgia syndrome (FMS) is a condition of chronic widespread pain. In its process of chronification psychosocial factors play an important role. A multimodal treatment including integrated group therapy has been proved to be effective. Yet little attention has been paid so far to the exact sequence of changes and interrelation between psychosocial factors, functional capacity, and level of pain under integrated group therapy for FMS patients. METHODS: One FMS patient was exemplarily monitored with an electronic diary over 13 weeks while undergoing integrated group therapy. On a daily basis we assessed the level of pain, functional capacity, and other disease-related variables (anxiety, depression, quality of sleep, self-efficacy) via visual analog scales. By the means of multivariate time series analysis the timing of changes in psychosocial factors and their effects on perceived functional capacity was identified. RESULTS: Under integrated group therapy all assessed variables gradually changed in the predicted way. Pain, depression, anxiety could be reduced, whereas self-efficacy, quality of sleep, and functional capacity improved. 71% of the variance could be explained by the multiple regression model. Self-efficacy was, beside pain intensity and depression, an important predictor for functional capacity on the same day. High self-efficacy correlated negatively with the level of functional capacity 3 days later. CONCLUSION: Integrated group therapy proved to be effective. Self-efficacy played an important role regarding the improvement of functional capacity. Depicting the exact timing of changes in the assessed variables helped to detect patterns of influence and indicate directions for further treatment.

[Psychosomatic aspects in the diagnosis and treatment of fibromyalgia]. / Psychosomatische Aspekte in Diagnostik und Therapie der Fibromyalgie.

The fibromyalgia syndrome (FMS) is a chronic pain condition of the musculoskeletal system defined by criteria of the American College of Rheumatology in 1990. Despite this definition, etiology and pathogenesis of FMS are still unknown, and consequently the therapy aims mainly at relieving symptoms. The favourite hypothesis is a multietiological concept including genetic, central nervous, muscular, and psychological issues. This article focuses on current psychological aspects as to etiology, process of chronification, and therapy of FMS. Regarding etiology there are diverging hypotheses rather than a general agreement, e.g. specific personality traits, traumatic events, psychodynamic explanations on the basis of a depressive conflict, or the subsumption under somatoform disorders. However, psychological aspects are evident to influence the course and treatment of FMS. In the chronification process behavioural aspects like avoidance behaviour with subsequent physical impairment, attitudes towards subjective theories of illness and therapeutic options, social factors like effects on work, interpersonal conditioning, and coping strategies play an important role. Therapeutic options of FMS comprise exercise, drugs, and psychotherapy. An integrated approach combining these options, a sustainable doctor-patient relationship, and a continuous support of the patient seem to be beneficial.