R. Scharnagel

Evaluation einer multimodalen Schmerztherapie am UniversitätsSchmerzCentrum Dresden

BACKGROUND Data of a multimodal pain management program of the multidisciplinary pain management centre at the University Hospital of Dresden is presented. Over a period of 4 weeks, supplemented by an additional week 3 months later (booster week), patients with chronic pain of different origins are being treated in groups of 12. Based on the principles of the biopsychosocial pain model and the idea of functional restoration, the program is dedicated for pain patients where outpatient treatment was insufficient. METHODS The program was evaluated on the basis of pain intensity (NRS), pain disability (PDI), fear and depression (HADS-D), catastrophizing (CSQ) and health-related quality of life and vitality (SF-36). The data were collected at the beginning and end of the initial 4 week treatment period, at the end of the booster period as well as 6 and 12 months after the end of active treatment. RESULTS A total of 189 patients were included in the program in the period from January 2006 until August 2008. All outcome parameter showed statistically significant improvements with small to high effect sizes (ES 0.20-0.95). The results stayed stable even 1 year after the treatment. The highest effect sizes were found in catastrophizing (ES 0.86) and average pain intensity (ES 0.95). The primary pain diagnosis (e. g. low back pain versus headache) had no impact on treatment outcome. CONCLUSION Significant and clinically relevant improvements could be achieved with the multimodal pain management program in groups of 12 patients. The results were stable over a time period of 1 year. Pain diagnosis had no impact on the outcome.

Chronische nichttumorbedingte Schmerzen

Annually published data show a continual increase in the volume of opioid prescriptions in Germany, thus indicating an intensification of opioid therapy. The majority of opioids are prescribed to treat chronic non-cancer-related pain. On the basis of current guidelines, as well as in terms of the lack of data regarding long-term use of opioids and their effectiveness beyond a period of 3 months, this development must be viewed critically. With reference to four case reports, we discuss and evaluate opioid therapy in relation to medication misuse and the development of drug dependency. Particular emphasis is placed on the administration of rapid-release and short-acting opioid preparations, which we consider to be particularly problematic.

[Chronic non-cancer-related pain. Long-term treatment with rapid-release and short-acting opioids in the context of misuse and dependency].

Annually published data show a continual increase in the volume of opioid prescriptions in Germany, thus indicating an intensification of opioid therapy. The majority of opioids are prescribed to treat chronic non-cancer-related pain. On the basis of current guidelines, as well as in terms of the lack of data regarding long-term use of opioids and their effectiveness beyond a period of 3 months, this development must be viewed critically. With reference to four case reports, we discuss and evaluate opioid therapy in relation to medication misuse and the development of drug dependency. Particular emphasis is placed on the administration of rapid-release and short-acting opioid preparations, which we consider to be particularly problematic.

Darf ein Patient unter Opioiden ans Steuer

Die langfristige Behandlung mit Opioiden ist ein wichtiger Bestandteil der medikamentösen Schmerztherapie. Dabei spielt für viele Patienten die Frage eine wichtige Rolle, ob sie trotz dieser Therapie bedenkenlos ein Auto steuern dürfen.

Cross-cultural adaptation, evaluation and validation of the Spouse Response Inventory: a study protocol

Introduction Since the response of spouses has been proven to be an important reinforcement of pain behaviour and disability it has been addressed in research and therapy. Fordyce suggested pain behaviour and well behaviour be considered in explaining suffering in chronic pain patients. Among existing instruments concerning spouses responses the aspect of well behaviour has not been examined so far. The SRI (Spouse Response Inventory) tries to consider pain behaviour and well behaviour and appears to be acceptable because of its brevity and close proximity to daily language. The aim of the study is the translation into German, followed by evaluation and validation, of the SRI on a German sample of patients with chronic pain. Methods and analyses The study is comprehensively designed: initially, the focus will lie on the translation of the instrument following the guidelines for cross-cultural translation and adaptation and evaluation of the German version according to the source study. Subsequently, a validation referring to predictive, incremental and construct validation will be conducted using instruments based on similar or close but different constructs. Evaluation of the resulting SRI-G (SRI-German) will be conducted on a sample of at least 30 patients with chronic pain attending a comprehensive pain centre. For validation at least 120 patients with chronic headache, back pain, cancer related pain and somatoform pain disorder shall be included, for a total of 480 patients. Separate analyses according to specific pain diagnoses will be performed to ensure psychometric property, interpretability and control of diagnosis of specific limitations. Analyses will include comprehensive investigation of psychometric property of the scale by hierarchical regression analyses, correlation analyses, multivariate analysis of variance and exploratory factor analyses (SPSS). Ethics The study protocol was approved by the Ethics Committee of the University of Dresden (EK 335 122008) based on the Helsinki declaration.

Chronische nichttumorbedingte SchmerzenChronic non-cancer-related pain

Annually published data show a continual increase in the volume of opioid prescriptions in Germany, thus indicating an intensification of opioid therapy. The majority of opioids are prescribed to treat chronic non-cancer-related pain. On the basis of current guidelines, as well as in terms of the lack of data regarding long-term use of opioids and their effectiveness beyond a period of 3 months, this development must be viewed critically. With reference to four case reports, we discuss and evaluate opioid therapy in relation to medication misuse and the development of drug dependency. Particular emphasis is placed on the administration of rapid-release and short-acting opioid preparations, which we consider to be particularly problematic.

Chronische nichttumorbedingte Schmerzen@@@Chronic non-cancer-related pain: Langzeitbehandlung mit schnell freisetzenden und kurz wirksamen Opioiden im Kontext von Missbrauch und Abhängigkeit@@@Long-term treatment with rapid-release and short-acting opioids in the context of misuse and dependency

Annually published data show a continual increase in the volume of opioid prescriptions in Germany, thus indicating an intensification of opioid therapy. The majority of opioids are prescribed to treat chronic non-cancer-related pain. On the basis of current guidelines, as well as in terms of the lack of data regarding long-term use of opioids and their effectiveness beyond a period of 3 months, this development must be viewed critically. With reference to four case reports, we discuss and evaluate opioid therapy in relation to medication misuse and the development of drug dependency. Particular emphasis is placed on the administration of rapid-release and short-acting opioid preparations, which we consider to be particularly problematic.

Utilisation of transdermal fentanyl in Germany from 2004–2006 by Edeltraut Garbe and colleagues

E. Garbe and colleagues report on critical issues regarding the utilisation of transdermal fentanyl patches for pain management in Germany.1 Their report and conclusion was the major impetus for the Drug Commission of the German Medical Association to publish a warning letter on the non-critical use of transdermal fentanyl and related severe side effects.2 The data used in this analysis is compelling due to the amount of data which could be analyzed. The authors demonstrated a trend towards initial use of transdermal fentanyl in higher dose ranges. Their major concern was the inappropriate prescribing pattern including high initial doses in a high-potency-opioid naïve (HPO-naïve) patient population, as well as the lack of adequate clinical indication for a transdermal route of opioid administration. These findings—since adopted by the German Drug Commission---raise serious concerns about safety issues. However, there are some shortcomings in the methodology as well as in the interpretation of the data. The potential limitation of the study is an overestimation of problems as a result of the frequent utilisation of transdermal fentanyl in Germany. Garbe et al. defined a HPO-naïve patient as a patient having no high-potent opioid (e.g. morphine, hydromorphone, oxycodone +/ naloxone, pethidine, piritramide, levomethadone or buprenorphine) in a period of 3months preceding the index date.1 However, this definition excluded all patients who have been on so-called “low-potency opioids” (e.g. codeine, tramadol, tilidine) before. This exclusion of patients who have been on low-potency opioids is not in line with the international literature.3–5 The discrimination of opioids in WHO-class 3 and 2 (high and low-potency) classes is in fact more an administrational as a clinically relevant differentiation. By this process, additional 13.865 patients were classified as HPO-naïve resulting in a total of 84.5% (n= 29.793) of all new transdermal fentanyl users being opioid-naïve. Taking into account that the term “opioid-naïve” should describe the absence of all opioids, the prevalence of potential inadequate fentanyl application was estimated artificially higher than a realistic clinical approach would generate. The second issue in the interpretation of the study relates to opioid therapy initiation. Starting opioid therapy with higher doses than the lowest available dose of transdermal fentanyl (delivery rate 12.5mg/h vs. ≥25mg/h) was regarded as problematic and potentially harmful. In 71.2% of the HPO-naïve new transdermal fentanyl users, the initial dose exceeded the lowest available dose of 12.5mg/h.1 A question unanswered related to the exceeded dose is: How many of those patients have been on WHO-step-2 opioids previously? If a patient failed on weaker opioids (e.g. 400–600mg tramadol), switching to transdermal fentanyl should result in an initial dose of 25mg/h at least. Another issue which has been mentioned in the study but which was not considered adequately is that cancer diagnosis among the so-called HPO-naïve patients was identified in 34.5% (n=10.283). The experience of uncontrolled pain due to inadequate opioid therapy, requiring a significant dose increase or switching to a more potent opioid, is not uncommon among cancer pain patients. Therefore, it might be necessary to start with doses exceeding 12.5–25mg/h to achieve adequate pain relief. In a study by Vielvoye-Kerkmeer and colleagues,WHO-Step-2 was skipped in 14 opioid-naïve cancer pain patients, and the initial transdermal fentanyl dose was 25mg/h. Only one patient dropped out due to side effects on day 2, whereas a dose increase was needed in 9 of 14 cancer patients within 3–6days.6 Klepstad et al. concluded in their systematic review that the optimal initial dose for titration of opioids in adult patients with pain due to cancer is 12.5–25mcg/h.7 Therefore, even when accepting the definition of HPO-naïve patients by Garbe et al., in 2006, approximately 80% of the incident fentanyl prescriptions were in this range.1 The identification of prescription patterns, where HPO-naïve patients received one fentanyl patch and no other HPO prescription afterwards led to the conclusion that transdermal fentanyl was used to treat acute pain only.1 However, another interpretation of

Evaluation einer multimodalen Schmerztherapie am UniversitätsSchmerzCentrum Dresden@@@Evaluation of a multimodal pain therapy at the University Pain Centre Dresden

BACKGROUND Data of a multimodal pain management program of the multidisciplinary pain management centre at the University Hospital of Dresden is presented. Over a period of 4 weeks, supplemented by an additional week 3 months later (booster week), patients with chronic pain of different origins are being treated in groups of 12. Based on the principles of the biopsychosocial pain model and the idea of functional restoration, the program is dedicated for pain patients where outpatient treatment was insufficient. METHODS The program was evaluated on the basis of pain intensity (NRS), pain disability (PDI), fear and depression (HADS-D), catastrophizing (CSQ) and health-related quality of life and vitality (SF-36). The data were collected at the beginning and end of the initial 4 week treatment period, at the end of the booster period as well as 6 and 12 months after the end of active treatment. RESULTS A total of 189 patients were included in the program in the period from January 2006 until August 2008. All outcome parameter showed statistically significant improvements with small to high effect sizes (ES 0.20-0.95). The results stayed stable even 1 year after the treatment. The highest effect sizes were found in catastrophizing (ES 0.86) and average pain intensity (ES 0.95). The primary pain diagnosis (e. g. low back pain versus headache) had no impact on treatment outcome. CONCLUSION Significant and clinically relevant improvements could be achieved with the multimodal pain management program in groups of 12 patients. The results were stable over a time period of 1 year. Pain diagnosis had no impact on the outcome.