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To evaluate efficacy and tolerability of the nonbenzodiazepine antispasmodic pridinol (PRI), as an add-on treatment in patients with muscle-related pain (MRP).Exploratory retrospective analysis of depersonalized routine data provided by the German Pain e-Registry (GPeR) focusing on pain intensity, pain-related disabilities in daily life, wellbeing, and drug-related adverse events (DRAEs).Primary endpoint based on a global response composite of (a) a clinically relevant analgesic response (relative improvement ≥50% and/or absolute improvement ≥ the minimal clinical important difference) for pain intensity and disability in combination with (b) an improvement in wellbeing (all at end of treatment vs. baseline), and (c) lack of any DRAEs.Between 1 January 2018 and 31 December 2020, the GPeR collected information on 121,803 pain patients of whom 1133 (0.9%; 54.5% female, mean ± SD age: 53.9 ± 11.8 years) received add-on PRI for the treatment of (mostly acute) MRP originating predominantly in the (lower) back (43.2%), lower limb (26.4%), or should/neck (21.1%). Average daily dose was 7.8 ± 1.8 (median 9, range 1.5-13.5) mg, duration of treatment 12.0 ± 10.2 (median 7, range 3-63) days. In total, 666 patients (58.8%) reported a complete, 395 (34.9%) a partial, and 72 (6.4%) patients no response - either because of lack of efficacy (Based on this real-world data of the German Pain e-Registry, add-on treatment with PRI in patients with acute MRP under real-world conditions in daily life was well tolerated and associated with an improvement of pain intensity, pain-related disabilities, and overall wellbeing.Muscle pain is one of the most common pain problems worldwide.In the majority of cases, muscle pain is temporary, transient, and benign in nature. However, people affected may still experience severe pain and significant pain-related disabilities in daily life activities that may require temporary drug treatment – also to be able to undertake the non-drug treatment measures necessary to prevent recurrence.Current treatment recommendations for muscle pain are largely “non-specific” and limited to symptomatic pain-relieving measures (e.g. NSAIDs), whereas muscle relaxants are currently not recommended (primarily due to insufficient efficacy data from controlled clinical trials) but are nevertheless frequently prescribed.In our analysis of depersonalized data from the German Pain e-Registry, the add-on treatment with pridinol proved to be effective and well tolerated in patients with muscle pain who have so far responded only insufficiently to recommended analgesic and adjuvant therapiesThe available real-world evidence data on efficacy and tolerability of PRI show a beneficial and clinically relevant activity, but confirmation by active or placebo-controlled clinical studies is still lacking.

To evaluate analgesic efficacy and safety/tolerability of the nonbenzodiazepine antispasmodic pridinol (PRI) in patients with muscle-related pain. Systematic review and meta-analysis of randomized placebo-controlled trials (RCTs) according to PRISMA guidelines and Cochrane recommendations. Data sources included Google Scholar, Embase, PubMed, ClinicalTrials.gov, EU Clinical Trials Registry, Chinese Clinical Trial Registry, UMIN Clinical Trials Registry, and product manufacturer archives from inception to 31 January 2022. Eligibility criteria for study selection were randomized, placebo-controlled trials with PRI in adults (≥18 years) with muscle-related pain. Data extraction, synthesis, and analysis carried out by two reviewers independently identified studies, extracted data, and assessed the risk of bias using the Cochrane risk of bias tool. Categorial global response rates (number of patients) based on clinical judgement of study physicians (as primary efficacy endpoint), and response on pain at rest, pain at movement, stiffness, tenderness, and movement restriction (as secondary efficacy endpoints), as well as the number of patients with drug-related adverse events (DRAEs) were meta-analytically evaluated using the Review Manager Software version 5.4.1. In total, 38 records were identified, but only two placebo-controlled studies (with 342 patients with mild to moderate acute muscle pain [55.3% female, age 50.6 ± 16.6 years], of whom 173 received PRI and 169 placebo, each as monotherapy) proved to be suitable for quantitative and qualitative analysis. Treatment with PRI was (irrespective of its mode of administration as oral tablet or intramuscular injection) associated with a significantly higher global response rate compared to placebo (74.0 vs. 49.7%; OR 2.86, 95%-CI: 1.82–4.51; p < .00001; Cohen´s h: 0.506, NNT: 4.1; Chi2 for heterogeneity 1.41 (p = .24], I2 = 29%), and significantly higher response rates were also found for all secondary efficacy endpoints. The safety of PRI was comparable to that of placebo: DRAEs were only seen in one of the two studies and reported for 13 vs. 10 patients (OR: 0.76 95%-CI: 0.32–18.1; p = .54, NNH: 62.6), and related discontinuations were reported for four vs. one patient (2.3 vs. 0.6%; p = .231). The results from this meta-analysis as based on two placebo-controlled studies in adult patients with mild to moderate acute muscle pain demonstrate that a 3-week monotherapy with PRI showed a comparable safety profile, but significantly better analgesic effects and improvements of related impairments such as stiffness, tenderness, and movement restrictions compared with placebo – irrespective of its mode of administration. Muscle pain is one of the most common pain problems worldwide. In the majority of cases, muscle pain is temporary, transient, and benign in nature. However, people affected may still experience severe pain and significant pain-related disabilities in daily life activities that may require temporary drug treatment – also in order to be able to undertake the non-drug treatment measures necessary to prevent recurrence. Current treatment recommendations for muscle pain are largely ´non-specific´ and limited to symptomatic pain-relieving measures (e.g. non-steroidal anti-inflammatories), while muscle relaxants – such as pridinol (PRI), which has been reapproved in Germany in 2017 and first time approved in the United Kingdom, Spain, and Poland in 2020 – are currently not recommended (primarily due to insufficient efficacy data from controlled clinical trials) but nevertheless frequently prescribed. Due to our systematic literature research of double-blind randomized and placebo-controlled trials, a 3-week monotherapy with PRI vs. placebo proved to be comparably tolerated, but significantly more effective in patients with muscle pain – irrespective of the mode of administration (oral or as intramuscular injection). These outcomes confirm already available real-world evidence on the beneficial efficacy and tolerability of PRI in daily practice. However, more recent RCTs or numerically larger comparative real-world evidence analyses are needed to evaluate the efficacy of PRI in comparison to currently recommended first-line therapies for patients with muscle pain.

Lay abstract Chronic low back pain is a common condition often resulting in impaired functioning in daily life and reduced quality of life and well-being of the patient. In case treatment with less potent pain medications is unsuccessful, opioid treatment might be required. Our study compared the effectiveness and tolerability of the prolonged release formulation of the atypical opioid tapentadol with other strong opioids commonly used for chronic pain treatment in Germany (morphine, hydromorphone, oxycodone ± naloxone). Anonymized patient data from German clinical practices collected in a pain registry were used (2331 comparable patients per treatment group). Patients receiving 12 weeks of tapentadol treatment experienced significantly greater pain relief, greater improvements in daily living activities, sleep, and quality of life compared with those receiving the other strong opioids investigated. Neuropathic pain components (pain features resembling nerve pain, often described as shooting, burning or stabbing pain) were reduced to a greater extent in the tapentadol treatment group. Tapentadol was also significantly better tolerated. This study showed that tapentadol is effective and well tolerated in chronic low back pain treatment in routine medical practice in patients still in considerable pain despite treatment with less potent pain medications.

ZusammenfassungAmbulante PET/CT-Leistungen sind für gesetzlich Versicherte nur für eine begrenzte Anzahl an Indikationen über den EBM erstattungsfähig. Für andere wichtige Indikationen erweist sich der Prozess der Beurteilung und Aufnahme in den EBM als außerordentlich langwierig, sodass über die Einzelfallentscheidung hinaus Sonderwege etabliert wurden, durch die sich Betroffene einer PET/CT-Untersuchung zulasten der GKV unterziehen können. Hierzu gehören die Besondere Versorgung, die ASV und Erprobungsstudien. Zusätzlich zur komplexen Erstattungssituation hat der Gesetzgeber den PET-Anwendern Qualitätssicherungsmaßnahmen auferlegt, deren Nichteinhaltung Sanktionen nach sich zieht. Dieser Artikel soll einen Überblick über die Möglichkeiten, Anforderungen und Hürden bieten, ambulante PET-Diagnostik über die GKV abzurechnen.

Drug-induced constipation (DIC) is a well-known comorbidity of cancer pain, however, data on its prevalence in nonmalignant pain (NMP) and its biopsychosocial effects are few.To assess the prevalence and impact of DIC in patients with NMP.Exploratory noninterventional, retrospective, cross-sectional analysis of depersonalized routine data of the German Pain e-Registry on 150,488 NMP patients (EUPAS identifier: 42286).DIC affects 33.5% of NMP patients. The most prevalent risk factors were the use of strong opioid analgesics and analgesic polymedication. Patients with DIC presented with significantly worse biopsychosocial scores as well as significantly higher percentages of individuals with severe deterioration of pain, daily life activities, physical and mental quality of life, mood, and overall wellbeing. Among patients with DIC, those who reported constipation as a clinical symptom and who documented bowel-function index (BFI) scores above the reference range were significantly more affected compared to those who either reported only constipation as an adverse event or elevated BFI scores. 55.9% of patients with DIC reported the use of laxatives, mostly over-the-counter preparations (43.6%), whereas prescription laxatives were taken by only 29.3%.DIC is a frequent comorbidity of pain management and affects around one-third of patients with NMP. It interferes significantly with pain-related biopsychosocial effects and has to be addressed specifically to improve the overall burden in affected patients. However, the use of laxatives was significantly less frequent than recommended indicating significant room for improvement.

Bei der Verordnung von Leistungen sollen sich Arzte am Gebot der Wirtschaftlichkeit orientieren — gerade bei Cannabis ist das aber leichter gesagt als getan. Aufgrund der zahlreichen Darreichungsformen und Wirkstoffarten lassen sich die einzelnen Produkte nur schwer direkt miteinander vergleichen. Somit lasst sich auch nur schwer feststellen, welche Form tatsachlich die gunstigste ist.

Background The EU gadolinium-based contrast agents (GBCA) market has changed in recent years due to the European Medicines Agency decision to suspend the marketing authorisation of linear GBCA and the marketing authorisation of new generic macrocyclic GBCA. The study aims to understand the patterns of (GBCA) use, and to study the effectiveness and safety of GBCA in routine practice across Europe. Methods Prospective, cross-sectional, multicentre, observational study in patients undergoing contrast-enhanced magnetic resonance. Reported usage patterns included indication, referral and examination details. Assessment of effectiveness included changes in radiological diagnosis, diagnostic confidence and image quality. Safety data were collected by spontaneous patient adverse event (AE) reporting. Results 2118 patients were included from 8 centres across 5 European countries between December 2018 and November 2019. Clariscan, Dotarem (gadoteric acid), Gadovist (gadobutrol) and ProHance (gadoteridol) were utilised in 1513 (71.4%), 356 (16.8%), 237 (11.2%) and 12 (0.6%) patients, respectively. Most were performed in CNS-related indications (46.2%). Mean GBCA doses were 0.10 mmol/kg body weight, except for Gadovist (mean 0.12 mmol/kg). GBCA use increased confidence in diagnosis in 96.2% of examinations and resulted in a change in radiological diagnosis in 73.9% of patients. Image quality was considered excellent or good in 96.1% of patients and across all GBCA. Four patients reported AEs (0.19%), with only 1 (0.05%) considered serious. Conclusions This European study confirmed that GBCAs are used appropriately in Europe for a wide range of indications. The study demonstrated a significant increase in diagnostic confidence after GBCA use and confirmed the good safety profile of GBCAs, with comparable results for all agents used.

Die Vorgaben von Leitlinien erweisen sich haufig als nicht praxistauglich oder spiegeln nur ein verzerrtes Bild des Praxisalltags wider. „Klug entscheiden in der Schmerzmedizin“ bedeutet aber nicht nur, externe, sondern auch interne Evidenz sowie die Patientenpraferenz zu berucksichtigen. Eine Arbeitsgruppe der DGS hat sich intensiv mit der Frage beschaftigt, wie sich Leitlinien in der Versorgung von Patienten mit chronischen Schmerzen auswirken und auswirken durfen.

Die Legalisierung der medizinischen Verwendung und die Vereinfachung der arztlichen Verordnung von Cannabis als (Schmerz-)Medizin offnet fur viele Menschen mit bislang therapieschwierigen und eventuell chronischen Schmerzen neue Perspektiven auf eine nachhaltige und nebenwirkungsarme Beschwerdelinderung. Hohe Erwartungen von Offentlichkeit und Betroffenen stehen in deutlichem Kontrast zu den eher ernuchternden Wirksamkeitsdaten aus kontrollierten Studien. Zusatzlich erschwert die Vielzahl verschiedener Darreichungsformen einen rationalen Umgang mit dieser neuen Behandlungsform — ein Umstand, der Ausgangspunkt einer Analyse anonymisierter Real-World-Daten des PraxisRegisters Schmerz zum Einsatz des THC:CBD-haltigen Oromukosalsprays war.

Ergebnisse einer retrospektiven Evaluation anonymisierter Behandlungsdaten des PraxisRegister Schmerz durch die Deutsche Gesellschaft fur Schmerzmedizin.

Aktuelle Daten zur Versorgungsqualitat von Patienten mit tumorbedingten Schmerzen fehlen fur Deutschland. Einzeitige Online-Querschnittsbefragung Betroffener im Rahmen der PraxisLeitlinien Initiative der Deutschen Gesellschaft fur Schmerzmedizin. Verwendung validierter Selbstauskunftsinstrumente und leitlinienbasierter Algorithmen zum Nachweis adaquater Behandlungskonzepte, Unter- und Fehlversorgung. Beteiligung von 5.576 Patienten mit tumorbedingten Schmerzen von denen 2.643 (47,4 %) zusatzlich auch unter tumorbedingten Durchbruchschmerzen litten. Bezuglich Dauer-/Durchbruchschmerzen zeigte sich bei 21,1/35,4 % eine Unterversorgung, bei 7,7/5,3 % eine Fehlversorgung und bei 23,7/30,6 % eine Kombination aus beidem. Insgesamt konnte nur bei 37,1 % (n = 2.071) eine formal adaquate Behandlung nachgewiesen werden, wobei mit 47,5 % der Anteil „ausreichend“ behandelter Dauerschmerzen deutlich hoher lag als der fur tumorbedingte Durchbruchschmerzen mit 28,7 % (p < 0,001). Unverandert ist die schmerzmedizinische Versorgung von Tumorpatienten in Deutschland unzureichend und von einer bunten Mischung aus Unter- und Fehlversorgung gekennzeichnet.

On behalf of the Medical/Psychological Pain Associations, Pain Patients Alliance and the Professional Association of Pain Physicians and Psychologists, the Joint Commission of Professional Societies and Organizations for Quality in Pain Medicine, working in close collaboration with the respective presidents, has developed verifiable structural and process-related criteria for the classification of medical and psychological pain treatment facilities in Germany. Based on the established system of graded care in Germany and on existing qualifications, these criteria also argue for the introduction of a basic qualification in pain medicine. In addition to the first-ever comprehensive description of psychological pain facilities, the criteria presented can be used to classify five different levels of pain facilities, from basic pain management facilities, to specialized institutions, to the Centre for Interdisciplinary Pain Medicine. The recommendations offer binding and verifiable criteria for quality assurance in pain medicine and improved pain treatment.

Der Gemeinsame Bundesausschuss hat entschieden, dass nur noch Arzte aus demselben Fachgebiet zweitmeinungsberechtigt sind. Noch gilt die Neuregelung nur fur drei Indikationen. Aber welchen Einfluss wird sie auf die Schmerzmedizin haben, wenn die Verfahrensregeln ausgeweitet werden?

Die Konzeption randomisierter (aktiv- wie placebokontrollierter) Studien beruht auf vorab definierten Annahmen uber den zu erwartenden Studienverlauf. Wesentliche, weil letztlich fur das Endergebnis und die Verallgemeinerung der dokumentierten Daten methodisch mitentscheidende Parameter sind die Fallzahl und die Power. Fehlende Messwerte (insbesondere im Falle von „Drop-outs“ bei longitudinalen Studien) konnen zu Verzerrungen, mitunter sogar zu falsch-positiven bzw. falsch-negativen Studienergebnissen fuhren. Im Normalfall werden deshalb bei Langsschnittbeobachtungen fehlende Beobachtungswerte mittels sog. Ersetzungsverfahren kunstlich erganzt. Ein diesbezuglich gerade bei schmerztherapeutischen Studien beliebtes Ersetzungsverfahren ist die „last observation carried forward“-Methode (LOCF), bei der im zeitlichen Verlauf einer Studie fehlende Beobachtungswerte durch den letzten zuvor verfugbaren Messwert ersetzt werden. Obwohl das LOCF-Verfahren im Allgemeinen als konservativ gilt, birgt es unter bestimmten Umstanden (z. B. bei vergleichenden Kohorten-Studien mit asymmetrischen Drop-out-Quoten) auch ein betrachtliches Potential fur kunstliche Effektuberschatzungen und Fehlaussagen. Am Beispiel eines fiktiven Datensatzes einer 12-wochigen Langsschnittuntersuchung werden mogliche Auswirkungen des LOCF-Verfahrens auf die Studienbewertung der analgetischen Wirksamkeit simuliert, kritische Einflussnahmen auf Studienendpunkte diskutiert und Kriterien fur erganzend sinnvolle bzw. fur eine neutrale Interpretation der Wirksamkeitsdaten durch den Leser notwendige Zusatzanalysen formuliert.

Im Auftrag der schmerzmedizinischen/psychologischen Fachgesellschaften, der Selbsthilfeorganisation der Schmerzpatienten und des Berufsverbandes der Schmerztherapeuten und Schmerzpsychologen hat die »Gemeinsame Kommission der Fachgesellschaften und Verbande fur Qualitat in der Schmerzmedizin« unter Mitwirkung der jeweiligen Prasidenten uberprufbare Struktur- sowie Prozesskriterien entwickelt, um schmerzmedizinische Einrichtungen in Deutschland klassifizieren zu konnen. Grundlage ist das in Deutschland etablierte System der abgestuften Versorgung sowie bestehende Qualifikationen, Weiterbildungen und Zusatzbezeichnungen. Die Einfuhrung eines Fachkundenachweises Schmerzmedizin wird empfohlen. Neben den erstmals beschriebenen schmerzpsychotherapeutischen Einrichtungen konnen anhand der Kriterien funf Ebenen von der Einrichtung mit Fachkunde Schmerzmedizin uber spezialisierte Einrichtungen bis zum Zentrum fur Interdisziplinare Schmerzmedizin definiert werden. Ziel der Empfehlungen ist es, verbindliche und uberprufbare Kriterien zur Qualitatssicherung in der Schmerzmedizin zu etablieren und die Versorgung zu verbessern.

Das Scheitern der Regelversorgung bei der Vermeidung bzw. Behandlung chronischer Ruckenschmerzen erfordert neue, patientenzentrierte Versorgungskonzepte. Mit dem integrierten Versorgungskonzept Ruckenschmerz (IV-R) entwickelte die Integrative Managed Care GmbH (IMC) zusammen mit der Deutschen Gesellschaft fur Schmerzmedizin e.V. (DGS) und der Techniker Krankenkasse ein individuell masgeschneidertes, multimodal und interdisziplinar ausgerichtetes Behandlungsprogramm. Bis Mitte des Jahres 2014 wurden 10.000 Patienten mit mindestens 28-tagiger ruckenschmerzbedingter Arbeitsunfahigkeit durch ihre gesetzlichen Krankenkassen identifiziert und eine Behandlung im Rahmen des IV-R-Konzeptes angeboten. Von den 7.380 aufgenommenen Patienten gelang es bei 59,4 % binnen vier, bei 87,3 % binnen acht Wochen eine 100%ige Arbeitsfahigkeit (bei 87,1 % nachhaltig uber mindestens sechs Monate) zu erzielen. Unabhangig von diesem primaren Behandlungsziel profitierte die Mehrzahl der behandelten Patienten von der integrierten Versorgung: Sie zeigte innerhalb des Behandlungszeitraums nicht nur signifikante und klinisch relevante Linderung bezuglich Schmerzintensitat, schmerzbedingter Beeintrachtigungen, korperlicher und seelischer Komorbiditaten, Funktionsbeeintrachtigungen und Lebensqualitat sondern auch bezuglich ihrer erkrankungsrelevanten Einstellungen, Erwartungen und Verhaltensmuster. Damit bietet das ergebnisorientiert konzipierte IV-R-Konzept nicht nur eine erfolgreiche und nachhaltig wirksame sondern auch eine kosteneffiziente (weil sich uber die Einsparungen ruckenschmerzbedingter Versorgungsleistungen gegenfinanzierende) Alternative zur etablierten Regelversorgung. The failure of routine care with respect to prevention and treatment of chronic back pain requires new, patient-centred health care concepts. With the integrated back pain care concept (IV-R), the Integrative Managed Care GmbH (IMC) developed together with the „Deutschen Gesellschaft fur Schmerzmedizin e.V. (DGS)“ and the „Techniker Krankenkasse“ an individually tailored treatment programme combining multimodal and interdisciplinary approaches. Until mid of the year 2014, 10.000 patients characterized by at least 28 days sick-leave due to back pain were identified by their compulsory health insurance companies and invited to participate in the IV-R program. Of those 7.380 patients who were finally enrolled, 59.4 % responded within four, 87.3 % within eight weeks and returned fully back to work – 87.1 % sustained over at least six months. Irrespective of this primary treatment target, the vast majority of patients benefitted from this treatment and showed significant and clinically relevant improvements with respect to pain intensity as well as pain-related physical and mental comorbidities, functional restrictions, quality-of-life, as well as disease-relevant attitudes. The outcome-focussed developed integrative treatment concept IV-R offered a highly and sustained effective and – due to savings with respect to per diem indemnities for back-pain – cost-efficient alternative to the established standard-of-care.

Ruckenschmerzen gehoren volkswirtschaftlich zu den teuersten Gesundheitsproblemen in den Industrienationen der westlichen Welt. Trotz intensiver Bemuhungen zur Verbesserung etablierter Behandlungsstrukturen und -pfade steigen Pravalenz und Kosten kontinuierlich an. Alternative multimodal und interdisziplinar realisierte, masgeschneiderte Versorgungskonzepte jenseits der Regelversorgung offnen mit ihren qualitatskontrollierten und ergebnisorientierten Vergutungskonzepten neue Perspektiven fur eine erfolgreiche, schnelle, nachhaltige und kosteneffiziente Behandlung Betroffener. Mit dem integrierten Versorgungskonzept Ruckenschmerz (IV-R) der Integrative Managed Care GmbH (IMC) wurde ein integriertes, interdisziplinares Programm zur Behandlung chronischer Ruckenschmerzpatienten unter aktiver Beteiligung von gesetzlicher Krankenkasse, schmerzmedizinischer Fachgesellschaft, zertifizierten Schmerzzentren, Managementorganisation und externer Qualitatskontrolle in Deutschland entwickelt.

Der Deutsche Schmerz- und Palliativtag 2016 vom 2. bis 5. Marz 2016 im Congress Center Frankfurt am Main stand unter dem Motto „Patientenversorgung im Mittelpunkt“. Fast 2.000 Teilnehmer folgten der Einladung von DGS und DSL zu unserem wichtigen Versorgerkongress. Im Fokus standen akute und chronische Schmerzen sowie die Behandlung der damit verbundenen Erkrankungen.

Subacute, muscle-related low/back pain (L/BP) is known to be difficult to treat and frequently requires more specific causal-oriented treatments with agents improving the increased muscle tone. Currently, only methocarbamol is approved and available for the 1st-line treatment of patients with muscle-related L/BP in Germany - however, without sufficient data on longer lasting effects (1 week) in elsewhere refractory patients.Noninterventional cohort study, based on anonymized routine data of the German pain practice registry; retrospective evaluation of patients with refractory L/BP, who first time received a treatment with methocarbamol between October 1st until December 31st, 2015, and who documented their response to treatment with the standardized and validated instruments of the German pain questionnaire over at least 4 weeks (n = 251 patients).During the 4-week evaluation period, patients reported a highly significant and clinically relevant improvement of pain intensity (from 53.0 ± 10.5 to 19.0 ± 10.0 mm VAS), pain-related disability in daily life (mPDI: from 42.1 ± 12.5 to 15.5 ± 10.8) and quality of life (QLIP: from 18.6 ± 6.3 to 34.0 ± 5.5; all changes p0.001 vs. baseline). Corresponding 50% response rates were 81.7 (n = 205), 68.5 (n = 172) und 91.6 (n = 230) %. In parallel, lumbar mobility (measured with the Schober's test) improved from 10.7 ± 0.7 to 14.7 ± 0.7 cm (p0,001). Overall, seven patients recorded eight minor treatment-related adverse events, which all resolved spontaneously during treatment without any specific countermeasures.Under the conditions of daily life, patients with elsewhere refractory L/BP reported a significant and clinically relevant improvement of pain intensity, pain-related disability and quality of life in response to a 4-week treatment with methocarbamol.

Der Stellenwert stark wirksamer Opioide fur die medikamentose Versorgung chronisch schmerzkranker Menschen wird kontrovers diskutiert. Individuelle Erfahrungen aus der alltaglichen Anwendung kontrastieren mit den Daten wissenschaftlicher Untersuchungen, wobei systematische empirische Erhebungen fehlen. Einzeitige Querschnittbefragung opioidverordnender Arzte zu verschiedensten Aspekten der Wirksamkeit und Vertraglichkeit stark wirksamer Opioidanalgetika in der alltaglichen Praxis. Anonymisierte Auswertung in Form zusammenfassender Gruppenanalysen. Teilnahme von 4283 Arzten mit einem kollektiven Erfahrungspool von 80 520 Behandlungsjahren. Opioidanalgetika als wichtigen Therapiebaustein dokumentierten bzgl. tumorbedingter Schmerzen 93,1% der Befragten, bzgl. degenerativer Gelenkerkrankungen 42,3%, bzgl. Kreuz-/Ruckenschmerzen 23,5% und bzgl. neuropathischer Schmerzen 18,1%. Keine Indikation sahen die befragten Arzte bei Fibromyalgie und Kopfschmerzen. Im Indikationsgebiet Kreuz-/Ruckenschmerzen wurden Opioidanalgetika als Mittel der ferneren Wahl bewertet, deren Einsatz zeitlich (mehrheitlich auf 3–6 Monate) befristet vorwiegend im Rahmen einer Kombinationstherapie mit anderen medikamentosen und nichtmedikamentosen Verfahren erfolgt. Haufigste unerwunschte Arzneimittelwirkung (UAW) in der Dauertherapie ist mit 49,1% die Obstipation, gefolgt von Mudigkeit (26,6%), Mundtrockenheit (22,7%) und Leistungsabfall (17,8%). 34,6% der Patienten benotigen wegen opioidbedingter UAW eine medikamentose Zusatztherapie, 15,2% brechen die Opioidbehandlung wegen intolerabler UAW vorzeitig ab. In dieser weltweit umfangreichsten, systematischen Arztebefragung werden stark wirksame Opioidanalgetika als sinnvolle und (meist) wirksame, jedoch auch nebenwirkungstrachtige Alternative zur Behandlung chronischer Schmerzen charakterisiert, deren gezielter vorubergehender Einsatz bei der Mehrzahl der Patienten mit einer relevanten Verbesserung von Schmerz, Funktionalitat und Lebensqualitat einhergehen kann.

OBJECTIVE Objective of this prospective, non-interventional study was to obtain data under a therapy with oral osmotic hydromorphone (OROS) in patients with chronic severe pain due to osteoarthritis under daily routineconditions. METHOD Using the Brief Pain Inventory (BPI) patients assessed pain relief as well as the impact of pain on activities of daily living. Pain control, treatment satisfaction (by patient and investigator), physical therapy capability and the WOMAC-Index (Western Ontario and McMaster Universities Osteoarthritis) were additionally evaluated. Adverse events were continuously monitored throughout the study. RESULTS 206 patients with chronic severe pain due to osteoarthritis and an initial pain intensity of 6 (NRS 0-10) received oral OROS-hydromorphone for three months. Under this treatment pain relief as well as the impact of pain on activities of daily living improved significantly. At the last examination, the patients reported a mean pain reduction of 2.5 (rest)/3.0 (movement) by day and of 2.6 (rest)/3.1 (movement) bynight (p < 0.0001). The very good pain control was accompanied by a high treatment satisfaction and an improved sleep quality. Physical therapy capability improved in 77.9% of the patients, the WOMAC index as indicator of pain and function in osteoarthritis decreased significantly from 13.3 (baseline) to 7.5 (V6). The most frequently reported adverse events were obstipation, nausea, dizziness and fatigue. 17.5% of the patients cut the study short because of adverse events. CONCLUSION The treatment of patients with chronic pain due to osteoarthritis with oral osmotic hydromorphone resulted in a significant reduction of all documented pain related assessments.

Hintergrund Aufgrund der aktuellen Anwendungsbeschrankung flupirtinhaltiger Arzneimittel durch die Europaische Arzneimittelbehorde auf 14 Tage besteht Unsicherheit/Unklarheit bzgl. des Ausmases der zu erwartenden analgetischen Effekte bei der Behandlung akuter Kreuz-/Ruckenschmerzen.

Background Six-months analysis of non-interventionally collected observation data of effectiveness of long-term treatment with low-dose 7-day buprenorphine transdermal patch in elderly patients with chronic pain. Methods Analysis of data regarding pain intensity, pain-related impairments of daily life and quality of life documented by 321 pain patients in German primary care (age 72.4 +/- 13.8 years; 67.3% female; musculoskeletal pain 85.4%; mean pain intensity 6.1 +/- 1.2, for 90% > or = 5 NRS11) using standardised self-report instruments (German Pain Questionnaire/German Pain Diary). Results After initiation with 5/10 microg/h buprenorphine (89.7%/10.3%), treatment was maintained in 57.1/39.1/3.8% patients with stable doses of 5/10/20 microg/h after 6 months. The average pain intensity decreased by 5.1 +/- 1.0 (absolute) to 1.0 +/- 1.0 NRS11 (83.5%), pain-related impairments and burden of pain were reduced by 86.0% and 87.9%, respectively, and pain-related quality of life improved by 97.3% to nearly normalvalues. Conclusions Pain treatment of elderly persons with 7-day low-dose transdermal buprenorphine patch on a stable dose regimen resulted in fast, effective and sustained pain relief accompanied by marked improvements in daily life participation and quality of life.

On behalf of the Medical/Psychological Pain Associations, Pain Patients Alliance and the Professional Association of Pain Physicians and Psychologists, the Joint Commission of Professional Societies and Organizations for Quality in Pain Medicine, working in close collaboration with the respective presidents, has developed verifiable structural and process-related criteria for the classification of medical and psychological pain treatment facilities in Germany. Based on the established system of graded care in Germany and on existing qualifications, these criteria also argue for the introduction of a basic qualification in pain medicine. In addition to the first-ever comprehensive description of psychological pain facilities, the criteria presented can be used to classify five different levels of pain facilities, from basic pain management facilities, to specialized institutions, to the Centre for Interdisciplinary Pain Medicine. The recommendations offer binding and verifiable criteria for quality assurance in pain medicine and improved pain treatment.

To evaluate patients' perceptions of 5% lidocaine medicated plaster for treatment of chronic neuropathic pain in daily clinical practice.In a prospective, multicentre, non-interventional observation, patient-reported outcome data were collected in clinical practices in Germany using the German Pain Questionnaire for pre-treatment documentation and the German Pain Diary for documentation of weekly treatment-associated changes. Questionnaires were completed by the patients without input from their physicians.Mean changes over the 12-week treatment period in pain intensity, in impairments of daily activities (modified pain disability index, mPDI) and of quality of life (quality of life impairment by pain inventory, QLIP), in Hospital Anxiety and Depression Scale scores (HADS-A and HADS-D), and in overall burden of pain.Data of 922 patients were evaluated. Mean average pain intensity over 24 h improved by 5.1 points (74%) from 6.9 ± 1.6 points at baseline. A 30% reduction in overall pain intensity was already observed within the first 2-3 weeks with continuous further reductions until end of observation. Marked improvements in anxiety and depression scores (40% and 52%, respectively), and in pain-related restrictions in daily life activities (66%) and quality of life (157%) were also noted. Burden of pain was reduced by 56.2 points (73%) from 77.5 points at baseline. Stratification by diagnosis showed a treatment effect of lidocaine plaster for all underlying conditions with highest treatment effects for diabetic polyneuropathy and postherpetic neuralgia.In a patient population where 46% of individuals already suffered from chronic to markedly chronic pain, patients perceive the 5% lidocaine medicated plaster as an efficacious topical treatment of chronic neuropathic pain in daily clinical practice. Strongest pain relief as well as associated improvements in pain-related restrictions were observed within the first five treatment weeks; however, beneficial effects continued until end of observation.

Die Etablierung eines Facharztes fur Schmerzmedizin scheitert weiterhin an Partikularinteressen. Eine bessere Versorgung von Patienten mit chronischen Schmerzen darf aber nicht scheitern. Die Deutsche Gesellschaft fur Schmerzmedizin (DGS) e.V. schlagt daher die „Spezialisierte Ambulante Schmerzmedizinische Versorgung“ (SASV) als neue Versorgungsstruktur vor.

Die Deutsche Gesellschaft fur Schmerzmedizin e.V. gratuliert Professor Dr. med. Dr. h.c. Walter Zieglgansberger von Herzen und mit groser Freude anlasslich der Verleihung des Bundesverdienstkreuzes. Sein Wirken, insbesondere seine Forschungsarbeit werden mit dieser hohen Auszeichnung angemessen gewurdigt.

Ruckenschmerzen gehoren zu den kostenintensivsten Gesundheitsproblemen in den westlichen Landern. Schuld daran sind nach Ansicht unserer Autoren vor allem eindimensionale Diagnostik- und Therapiekonzepte. Sie vernachlassigen komplexe psychosoziale Aspekte und begunstigen eine Chronifizierung der Beschwerden. Das „Farbleitsystem“ unserer Autoren verdeutlicht die Zusammenhange.

Ein Patient mit einem Hexenschuss kann sich zwar kaum bewegen, dennoch sollten Sie ihn davon abhalten, sich ins Bett zu legen und auf das Ende seiner Schmerzen zu hoffen. Was Sie Ihren Ruckenschmerzpatienten auser Bewegung noch empfehlen konnen, haben unsere Schmerzspezialisten fur Sie zusammengefasst.

Current restrictions in use of flupirtine-containing medicines for a maximum of 14 days endorsed by the European Medicines Agency were followed by uncertainty/ambiguity of its analgesic efficacy for the treatment of acute low/back pain.Post-hoc selection of patient-level data from non-interventional studies with flupirtine MR and diclofenac with respect to patient age (or = 18 years), duration of treatment (14 +/- 2 days), indication (acute/subacute low/back pain) and first-line use. Primary endpoint: average 24-hr. pain intensity; secondary endpoints: pain-related disabilities in daily life, 30/50/70% response with respect to pain and pain-related restrictions, frequency of untoward side effects/treatment emergent adverse events.318/31 patients treated with flupirtine MR/diclofenac fulfilled the inclusion criteria for this subgroup analysis. Starting from comparable demographic and baseline characteristics both treatments were followed by significant effects (p0.001). Subgroup comparisons revealed superior effects for flupirtine MR vs. diclofenac for pain relief (p = 0.001), improvement of pain-related restrictions in daily life (p = 0.023), and gastrointestinal/overall tolerability (p0.001).Even for short-term use in patients suffering from muscle-related acute low/back pain, flupirtine MR is superior effective and tolerated compared with the nsaid diclofenac.

Six-months analysis of non-interventionally collected observation data of effectiveness of long-term treatment with low-dose 7-day buprenorphine transdermal patch in elderly patients with chronic pain.Analysis of data regarding pain intensity, pain-related impairments of daily life and quality of life documented by 321 pain patients in German primary care (age 72.4 +/- 13.8 years; 67.3% female; musculoskeletal pain 85.4%; mean pain intensity 6.1 +/- 1.2, for 90%or = 5 NRS11) using standardised self-report instruments (German Pain Questionnaire/German Pain Diary).After initiation with 5/10 microg/h buprenorphine (89.7%/10.3%), treatment was maintained in 57.1/39.1/3.8% patients with stable doses of 5/10/20 microg/h after 6 months. The average pain intensity decreased by 5.1 +/- 1.0 (absolute) to 1.0 +/- 1.0 NRS11 (83.5%), pain-related impairments and burden of pain were reduced by 86.0% and 87.9%, respectively, and pain-related quality of life improved by 97.3% to nearly normalvalues.Pain treatment of elderly persons with 7-day low-dose transdermal buprenorphine patch on a stable dose regimen resulted in fast, effective and sustained pain relief accompanied by marked improvements in daily life participation and quality of life.

Objective of this prospective, non-interventional study was to obtain data under a therapy with oral osmotic hydromorphone (OROS) in patients with chronic severe pain due to osteoarthritis under daily routineconditions.Using the Brief Pain Inventory (BPI) patients assessed pain relief as well as the impact of pain on activities of daily living. Pain control, treatment satisfaction (by patient and investigator), physical therapy capability and the WOMAC-Index (Western Ontario and McMaster Universities Osteoarthritis) were additionally evaluated. Adverse events were continuously monitored throughout the study.206 patients with chronic severe pain due to osteoarthritis and an initial pain intensity of 6 (NRS 0-10) received oral OROS-hydromorphone for three months. Under this treatment pain relief as well as the impact of pain on activities of daily living improved significantly. At the last examination, the patients reported a mean pain reduction of 2.5 (rest)/3.0 (movement) by day and of 2.6 (rest)/3.1 (movement) bynight (p0.0001). The very good pain control was accompanied by a high treatment satisfaction and an improved sleep quality. Physical therapy capability improved in 77.9% of the patients, the WOMAC index as indicator of pain and function in osteoarthritis decreased significantly from 13.3 (baseline) to 7.5 (V6). The most frequently reported adverse events were obstipation, nausea, dizziness and fatigue. 17.5% of the patients cut the study short because of adverse events.The treatment of patients with chronic pain due to osteoarthritis with oral osmotic hydromorphone resulted in a significant reduction of all documented pain related assessments.

Non-interventional study in outpatient, contrast-enhanced CT; 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions..Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least "possible" relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration.About 55.5 % of patients showed one or more risk factors (e. g. impaired renal function 4.4 %, diabetes mellitus 8.5 %, hypertension 20.6 %). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5 - 50.5 %). Oral hydration was the main preventive measure in patients with renal risk factors ( 8 %) followed by intravenous hydration (1 %). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74 %), but were classified as serious in only 3 patients (0.03 %). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found.The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated more often, depending on their history. In the routine outpatient setting, iso-osmolar iodixanol was very well tolerated in almost 10,000 patients undergoing diagnostic CT. The rate of acute and delayed adverse reactions was low. No correlation could be found between risk factors, preventive measures and the incidence of adverse drug reactions.• Rare use of preventive measures for outpatient CT examinations.• Low rate of acute and late adverse drug reactions to iodixanol.• No correlation between risk factors, preventive measures and adverse drug reactions.