Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial.

BACKGROUND: Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. METHODS: This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. DISCUSSION: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. TRIAL REGISTRATION: ClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.

[Considerations concerning the perioperative use of metamizole]. / Überlegungen zum perioperativen Einsatz von Metamizol.

BACKGROUND: The non-opioid analgesic metamizole (dipyrone) is approved for the treatment of severe pain and is often used in the perioperative period. As it can cause agranulocytosis, a severe adverse event, its perioperative administration is controversially discussed. OBJECTIVE: Is there enough evidence for a high risk of metamizol-induced agranulocytosis (MIA)? What are the consequences of its perioperative use with respect to the risk profiles of alternative analgesics? MATERIAL AND METHODS: Rapid review of the literature on the risk of MIA and adverse effects of non-opioid analgesics. RESULTS: The incidence of MIA is estimated to be one case per million inhabitants per year. The risk seems low compared to other drugs associated with a risk of agranulocytosis, such as antithyroid drugs and ticlopidine. The risk profile of metamizole concerning hepatotoxicity, nephrotoxicity, bleeding and cardiovascular adverse effects is favorable compared to other non-opioid analgesics. None of the non-opioid analgesics are licensed to be administered intraoperatively. CONCLUSION: The perioperative use of metamizole is possible after a thorough evaluation of the indications as it provides good analgesia with a generally favorable side effect profile and is administered intravenously. The risk of agranulocytosis is small but needs to be mentioned during patient informed consent in order to optimize early recognition. Intraoperative administration aims at reducing the expected severe postoperative pain. A documentation and justification for the evaluation of the indications are recommended.

[Cross-sectoral interdisciplinary multimodal pain therapy : Recommendations on structural and process parameters of the ad hoc commission "Interdisciplinary Multimodal Pain Therapy" of the German Pain Society (Deutsche Schmerzgesellschaft e.  V.)]. / Sektorenübergreifende interdisziplinäre multimodale Schmerztherapie : Empfehlungen zu Struktur- und Prozessparametern der Ad-hoc-Kommission "Interdisziplinäre Multimodale Schmerztherapie" der Deutschen Schmerzgesellschaft e. V.

Based on the fundamental concept of the biopsychosocial model, interdisciplinary multimodal pain therapy (IMPT) has developed to one of the most important components in the treatment of patients suffering from chronic pain. The process criteria for IMPT in Germany are described in the German OPS catalogue and IMPT is mainly offered as an inpatient treatment only. This article updates some of the fundamental criteria for IMPT for adult inpatient treatment and the task force defines basic structural and process criteria for the implementation of IMPT for outpatients.

Acupuncture reduces the time from extubation to 'ready for discharge' from the post anaesthesia care unit: results from the randomised controlled AcuARP trial.

Acupuncture may improve peri-operative care as it reduces post-operative symptoms, such as pain, nausea and vomiting, or sedation. This patient-assessor blinded, randomised trial in 75 women undergoing gynaecologic laparoscopy evaluated the effects of acupuncture combined with a standardised anaesthetic regimen (ACU) on post-anaesthetic recovery, when compared to acupressure (APU) or standard anaesthesia alone (CON). Main outcome measure was the time from extubation to 'ready for discharge' from recovery as assessed by validated questionnaires. The main outcome differed significantly between groups (p = 0.013). Median time to ready for discharge in the ACU group (30 (IQR: 24-41) min) was 16 minutes (35%) shorter than in the CON group (46 (36-64) min; p = 0.015) and tended to be shorter than in the APU group (43 (31-58) min; p = 0.08). Compared to CON (p = 0.029), median time to extubation was approximately 7 minutes shorter in both, the ACU and the APU group. No acupuncture or acupressure-related side-effects could be observed. A difference in time to recovery of 16 minutes compared to standard alone can be considered clinically relevant. Thus, results of this study encourage the application of acupuncture in gynaecological laparoscopy as it improves post-anaesthetic recovery.

[Implementation of interdisciplinary multimodal pain therapy according to OPS 8­918 : Recommendations of the ad hoc commission for interdisciplinary multimodal pain therapy of the German Pain Association]. / Umsetzung der interdisziplinären multimodalen Schmerztherapie nach OPS 8­918 : Empfehlungen der Ad-hoc-Kommission "Interdiziplinäre multimodale Schmerztherapie" der Deutschen Schmerzgesellschaft.

With the implementation of the German diagnosis-related groups (DRG) reimbursement system in hospitals, interdisciplinary multimodal pain therapy was incorporated into the associated catalogue of procedures (OPS 8­918). Yet, the presented criteria describing the procedure of interdisciplinary multimodal pain therapy are neither precise nor unambiguous. This has led to discrepancies in the interpretation regarding the handling of the procedure-making it difficult for medical services of health insurance companies to evaluate the accordance between the delivered therapy and the required criteria. Since the number of pain units has increased in recent years, the number of examinations by the medical service of health insurance companies has increased. This article, published by the ad hoc commission for interdisciplinary multimodal pain therapy of the German Pain Association, provides specific recommendations for correct implementation of interdisciplinary multimodal pain therapy in routine care. The aim is to achieve a maximum level of accordance between health care providers and the requirements of the medical examiners from health insurance companies. More extensive criteria regarding interdisciplinary multimodal pain treatment in an in-patient setting, especially for patients with chronic and complex pain, are obviously needed. Thus, the authors further discuss specific aspects towards further development of the OPS-code. However, the application of the OPS-code still leaves room regarding treatment intensity and process quality. Therefore, the delivery of pain management in sufficient quantity and quality still remains the responsibility of each health care provider.

[Chronic pain disorder with somatic and psychological factors (F45.41) : Validation criteria on operationalization of the ICD-10-GM diagnosis]. / Chronische Schmerzstörung mit somatischen und psychischen Faktoren (F45.41) : Prüfkriterien zur Operationalisierung der ICD-10-GM-Diagnose.

In 2009 the diagnosis chronic pain disorder with somatic and psychological factors (F45.41) was integrated into the German version of the International Classification of Diseases, version 10 (ICD-10-GM). In 2010 Paul Nilges and Winfried Rief published operationalization criteria for this diagnosis. In the present publication the ad hoc commission on multimodal interdisciplinary pain therapy of the German Pain Society now presents a formula for a clear validation of these operationalization criteria of the ICD code F45.41.

No effect of the cyclooxygenase-2 inhibitor etoricoxib on pre-emptive and post-operative analgesia in visceral surgery: results of a randomized controlled trial.

BACKGROUND: Pre-emptive analgesia in perioperative care has potential benefits for patients. The pre-emptive and postoperative analgesic effects of the cyclooxygenase-2 inhibitor etoricoxib have been investigated using a 2 × 2 factorial trial design. METHODS: According to the 2 × 2 factorial study design, 103 patients scheduled for visceral surgery, were randomly allocated to two groups prior to surgery. Patients could receive either etoricoxib or placebo (to investigate pre-emptive analgesia). Subsequent to surgery, patients randomly received either etoricoxib or placebo, again. It follows, that four treatment modalities (continuous or replaced intervention) result, to investigate postoperative analgesia. Main Outcome Measure was the cumulative morphine use 48 h post-surgery. Other outcomes included pain intensities, pain thresholds and sensory detection. RESULTS: Eighty-six patients (female n = 42; mean age 53.82 ± 13.61 years) were evaluated on the basis of an intention to treat analysis. Pre-emptive administration of 120 mg etoricoxib did not significantly reduce the cumulative morphine dose within the first 48 h after surgery, when compared to the administration of placebo. The analysis of the post-operative treatment groups showed a non-significant 8% reduction in morphine dose during the continuous administration of etoricoxib. There were no changes in sensory perception as detected with QST before and after surgery or between groups. CONCLUSIONS: The effect of administering etoricoxib was not superior to placebo in reducing the morphine dose required for postoperative analgesia. The lack of changes in peripheral nociception suggests that central algetic mechanisms are of higher impact in the development of postoperative pain following abdominal or thoracic surgery.

[Acute inpatient multimodal pain therapy and rehabilitation: Framework conditions, tasks and differentiated patient allocation]. / Akutstationäre multimodale Schmerztherapie und Rehabilitation: Rahmenbedingungen, Aufgaben und differenzierte Patientenzuweisung.

Multimodal pain treatment programs are widely accepted as the medical treatment standard in the management of patients with chronic pain syndromes. The concepts and treatment strategies are based on the biopsychosocial model of pain and programs for early restoration of function. Although this concept is primarily implemented in the curative field, i.e. in hospitals for the treatment of patients with chronic pain diseases, modified programs based on the International Classification of Functioning (ICF) can now also be found in rehabilitation clinics. Despite the assumed similarities, significant differences in, for example the aims of the therapy and relevant structural and process variables have to be kept in mind when allocating patients to a program as provided by a hospital or a rehabilitation clinic. The aim of this article is to present the framework structures of both treatment levels with respect to the implementation of multimodal pain therapy programs and to elucidate the differential diagnostic approach to the indications.

[Multimodal pain therapy for treatment of chronic pain syndrome. Consensus paper of the ad hoc commission on multimodal interdisciplinary pain management of the German Pain Society on treatment contents]. / Multimodale Schmerztherapie für die Behandlung chronischer Schmerzsyndrome. Ein Konsensuspapier der Ad-hoc-Kommission Multimodale interdisziplinäre Schmerztherapie der Deutschen Schmerzgesellschaft zu den Behandlungsinhalten.

Multimodal pain management is a comprehensive treatment of complex chronic pain syndromes. In addition to medical therapy various other specialized therapeutic interventions based on the biopsychosocial model of pain origin and chronic pain development, are added. During the last few years treatment centers for chronic pain have been established throughout Germany. Multimodal pain management has been included in the official catalogue of the recognized medical procedures for day clinic units as well as for inpatient pain management. In daily practice there is, however, still a lack of clarity and of consistency about the components that multimodal pain management should contain. This is the reason for the ad hoc commission on multimodal interdisciplinary pain management of the German Pain Society to propose the following position paper that has been worked out in a multilevel and interdisciplinary consensus process. The paper describes the mandatory treatment measures in the four core disciplines of multimodal pain management, pain medicine, psychotherapy, exercise therapy including physiotherapy and assistant medical professions including nurses.

[Update on preemptive analgesia : options and limits of preoperative pain therapy]. / Update zur präemptiven Analgesie : Möglichkeiten und Grenzen der präoperativen Schmerztherapie.

BACKGROUND: Wall created the term preemptive analgesia in 1988 and in doing so set in motion a movement to prevent acute and chronic postsurgical pain. The concept of preemptive analgesia implies the administration of analgesic drugs or an intervention before a surgical procedure. A preemptive analgesic approach can comprise non-steroidal anti-inflammatory drugs (NSAID) and cyclo-oxygenase-2 inhibitors (coxibs) used to decrease the production of prostaglandins, local anesthetics (e.g. epidural) to reduce nociceptive input to the spinal cord as well as opioids, N-methyl-D-aspartate (NMDA) antagonists, antidepressants and anticonvulsants, all of which have an inhibitory influence on the central nervous system. AIM: The aim of this article is to present the current possibilities and limits of preoperative pain therapy. MATERIAL AND METHODS: Since 2002 several meta-analyses on the effectiveness of preemptive analgesia have been published which came to varying conclusions on the supportive use of preemptive analgesia. The S3 guidelines on current perioperative pain management developed by the German Interdisciplinary Association for Pain Management (DIVS) specify the preemptive analgesic interventions found to be effective and will be discussed in detail in this article. Furthermore, the results of a current meta-analysis which follows the principle of preventive analgesia will be presented and which have not yet been considered in the S3 guidelines. RESULTS: Preemptive analgesia can reduce acute postoperative pain; however, minimizing the development of chronic pain conditions can only be successful in combination with intraoperative and postoperative pain therapy as well as social and psychological support when indicated (preventive analgesia). CONCLUSION: Reduction of chronic postoperative pain is an important medical function which is also justified from socioeconomic perspectives. Future studies should combine several procedures for perioperative pain therapy in order to do justice to the multifactorial aspects of pain chronification and should also be planned over a sufficiently long observation time period.

[Gender differences in acute and chronic pain conditions. Implications for diagnosis and therapy]. / Geschlechtsspezifische Aspekte bei akuten und chronischen Schmerzen. Implikationen für Diagnose und Therapie.

Gender differences can influence incidence and outcome of acute and chronic pain conditions. The reasons are to be found in genetic factors, hormonal effects and differences in anatomy and physiology. Furthermore differences relating to psychiatric comorbidities (i.e. depression) and psychosocial factors (roles, coping strategies) have been demonstrated. Men and women differ in the response to drugs and other treatments. They are differently affected by side effects of drugs. There is a gender bias in diagnosis and therapy. There is a need to study the influence of gender, age and race in order to optimize treatment towards a more individualized therapy. This article highlights already identified differences.

[Multidisciplinary assessment for multimodal pain therapy. Indications and range of performance]. / Interdisziplinäres Assessment zur multimodalen Schmerztherapie. Indikation und Leistungsumfang.

According to evidence-based German national guidelines for non-specific low back pain, a broad multidisciplinary assessment is indicated after persisting pain experience of 6 weeks in order to check the indications for an multi- and interdisciplinary pain therapy program. In this paper the necessary topics, the content and the disciplines involved as well as the extent of the multidisciplinary assessment are described as developed by the ad hoc commission on multimodal pain therapy of the German Pain Society.

[Structure and process quality of multimodal pain therapy. Results of a survey of pain therapy clinics]. / Struktur- und Prozessqualität multimodaler Schmerztherapie. Ergebnisse einer Befragung von schmerztherapeutischen Einrichtungen.

Multimodal therapy has demonstrated good clinical effectiveness in the treatment of chronic pain syndromes. However, within the German health system a comprehensive and nationwide access to multimodal therapy is not available and further improvement is therefore necessary. In order to analyze the current status of multimodal therapy and specifically its structural and procedural requirements and qualities, a survey was carried out in 37 pain clinics with established multimodal treatment programs. An anonymous questionnaire was used for data collection. Results demonstrated that a substantial accordance was found between all pain clinics concerning requirements for space, facilities and staff. Structured multidisciplinary assessments were carried out by all pain clinics even though the amount of time allocated for this varied widely. The main focus of multimodal therapy in all facilities was based on a common philosophy with a cognitive-behavioral approach to reduce patient helplessness and avoidance behavior and to increase physical and psychosocial activities as well as to strengthen self-efficacy. Some differences in the ways and means to achieve these goals could be demonstrated in the various programs.

[Gender aspects in anesthesia : modified approach in research and treatment?]. / Gender-Aspekte in der Anästhesie : Modifiziertes Vorgehen in Forschung und Versorgung?

Gender differences can have a relevant influence on the perioperative outcome as male and female patients are affected differently by adverse events, e.g. side effects of drugs. Furthermore, differences relating to specific drug effects, comorbidities and outcome after anesthesia or intensive care have been demonstrated. There seems to be a gender bias in diagnosis and therapy. While the knowledge regarding this field is still growing certain aspects have already been integrated into clinical practice: prevention of postoperative nausea and vomiting (PONV), target controlled infusion (TCI) model and male only policy with production of blood products. There is a need to study the influence of gender, age and race in order to optimize treatment towards a more individualized therapy. This article highlights already identified differences and discusses potential underlying mechanisms.

[Acupuncture in emergency medicine : results of a case series]. / Akupunktur in der Notfallmedizin : Ergebnisse einer Fallserie.

BACKGROUND: Acupuncture (AP) might be indicated in emergency medicine. This case series was performed to demonstrate the practicability and possible effects of AP in emergency medical services (EMS) as a basis for randomized controlled trials (RCT). SUBJECTS AND METHODS: A total of 60 patients (average age 55.4±23.0 years, 57% female) treated by the EMS received AP if applicable. Main outcome parameter was to rate the symptom alleviating effect of acupuncture treatment on a 4-point scale or by VAS. RESULTS: Of the 60 patients 35 (58%) reported considerable improvement, 15 patients (25%) reported complete relief and 10 patients (17%) reported no changes in the cardinal symptom. The predominant symptoms alleviated by AP were nausea (n=31) and vomiting (n=21). Pericardium 3 and 6 (27%) and Spleen 6 and 9 were the most commonly used AP points. CONCLUSION: This case series demonstrates that AP can alleviate certain symptoms in emergency patients. The results of the study provide data as a basis to perform clinical controlled trials on the effectiveness of AP in emergency medicine.

Influence of acupuncture on type I hypersensitivity itch and the wheal and flare response in adults with atopic eczema - a blinded, randomized, placebo-controlled, crossover trial.

BACKGROUND: Itch is a major symptom of allergic skin disease. Acupuncture has been shown to exhibit a significant effect on histamine-induced itch in healthy volunteers. We investigated the effect of acupuncture on type I hypersensitivity itch and skin reaction in a double-blind, randomized, placebo-controlled, crossover trial. METHODS: An allergen stimulus (house dust mite or grass pollen skin prick) was applied to 30 patients with atopic eczema before (direct effect) and after (preventive effect) two experimental approaches or control observation: acupuncture at points Quchi and Xuehai [verum acupuncture (VA), dominant side], 'placebo-point' acupuncture (PA, dominant side), no acupuncture (NA). Itch intensity was recorded on a visual analogue scale. After 10 min, wheal and flare size and skin perfusion (via LASER-Doppler) were measured at the stimulus site, and the validated Eppendorf Itch Questionnaire (EIQ) was answered. RESULTS: Mean itch intensity was significantly lower in VA (35.7 +/- 6.4) compared to NA (45.9 +/- 7.8) and PA (40.4 +/- 5.8) regarding the direct effect; and significantly lower in VA (34.3 +/- 7.1) and PA (37.8 +/- 5.6) compared to NA (44.6 +/- 6.2) regarding the preventive effect. In the preventive approach, mean wheal and flare size were significantly smaller in VA (0.38 +/- 0.12 cm(2)/8.1 +/- 2.0 cm(2)) compared to PA (0.54 +/- 0.13 cm(2)/13.5 +/- 2.8 cm(2)) and NA (0.73 +/- 0.28 cm(2)/15.1 +/- 4.1 cm(2)), and mean perfusion in VA (72.4 +/- 10.7) compared to NA (84.1 +/- 10.7). Mean EIQ ratings were significantly lower in VA compared to NA and PA in the treatment approach; and significantly lower in VA and PA compared to NA in the preventive approach. CONCLUSIONS: Acupuncture at the correct points showed a significant reduction in type I hypersensitivity itch in patients with atopic eczema. With time the preventive point-specific effect diminished with regard to subjective itch sensation, whereas it increased in suppressing skin-prick reactions.

Low concentrations of amitriptyline inhibit nicotinic receptors in unmyelinated axons of human peripheral nerve.

BACKGROUND AND PURPOSE: Amitriptyline is often prescribed as a first-line treatment for neuropathic pain but its precise mode of analgesic action remains uncertain. Amitriptyline is known to inhibit voltage-dependent ion channels and also to act as an antagonist at ligand-gated ion channels, such as nicotinic acetylcholine receptors (nAChRs). In the present study, we tested the effect of amitriptyline on nicotinic responses of unmyelinated axons in isolated segments of human peripheral nerve. In particular, a comparison was made between the concentrations of amitriptyline necessary for inhibition of nAChRs and those required for inhibition of the compound C-fibre action potential. EXPERIMENTAL APPROACH: Isolated axon fascicles were prepared from short segments of human sural nerve, and multiple measures of axonal excitability were recorded using computer-controlled threshold tracking software. KEY RESULTS: Amitriptyline (EC(50) 2.6 microM) reduced the nicotine-induced increase in C-fibre excitability but only slightly altered the amplitude and latency to onset of the compound action potential. In contrast, tetrodotoxin produced a clear reduction in the amplitude and a prolongation of action potential onset latency but was without effect on the nicotine-induced increase in axonal excitability. CONCLUSIONS AND IMPLICATIONS: These data demonstrate that low concentrations of amitriptyline suppress the response of human peripheral C-type axons to nicotine by directly inhibiting nAChRs. Blockade of tetrodotoxin-sensitive, voltage-dependent sodium channels does not contribute to this effect. An inhibitory action of amitriptyline on nAChRs in unmyelinated nociceptive axons may be an important component of amitriptyline's therapeutic effect in the treatment of neuropathic pain.

[Acupuncture: basics, practice, and evidence]. / Akupunktur: grundlagen, praxis und evidenz.

Acupuncture, which originated with traditional Chinese medicine, has been increasingly used in Western medicine over the last three decades. A huge body of scientific literature reports the physiological and clinical effects of acupuncture. In Germany, about 30,000 physicians apply acupuncture at least occasionally, and German health insurances reimburse acupuncture treatment for chronic low back pain and osteoarthritis of the knee. This overview discusses the most important historical, theoretical, practical, and scientific aspects of acupuncture in general, with a special look at anaesthesia. Regarding anaesthesia, supportive acupuncture treatment is performed for postoperative pain, anxiolysis, and postoperative nausea and vomiting, based on promising results of rigorous randomised trials. However, many unresolved questions remain, such as regarding specificity of concepts, indications, and optimum dose.

[Acupuncture. Basics, practice, and evidence]. / Akupunktur: Grundlagen, Praxis und Evidenz.

Acupuncture, which originated with traditional Chinese medicine, has been increasingly used in Western medicine over the last three decades. A huge body of scientific literature reports the physiological and clinical effects of acupuncture. In Germany, about 30,000 physicians apply acupuncture at least occasionally, and German health insurances reimburse acupuncture treatment for chronic low back pain and osteoarthritis of the knee. This overview discusses the most important historical, theoretical, practical, and scientific aspects of acupuncture in general, with a special look at anaesthesia. Regarding anaesthesia, supportive acupuncture treatment is performed for postoperative pain, anxiolysis, and postoperative nausea and vomiting, based on promising results of rigorous randomised trials. However, many unresolved questions remain, such as regarding specificity of concepts, indications, and optimum dose.