Efficacy and safety/tolerability of pridinol: a meta-analysis of double-blind, randomized, placebo-controlled trials in adult patients with muscle pain.

OBJECTIVE: To evaluate analgesic efficacy and safety/tolerability of the nonbenzodiazepine antispasmodic pridinol (PRI) in patients with muscle-related pain. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Efficacy and tolerability of the antispasmodic, pridinol, in patients with muscle-pain - results of primepain, a retrospective analysis of open-label real-world data provided by the German pain E-registry.

OBJECTIVE: To evaluate efficacy and tolerability of the nonbenzodiazepine antispasmodic pridinol (PRI), as an add-on treatment in patients with muscle-related pain (MRP). METHODS: 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. RESULTS: 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 (n = 2, 0.2%) or DRAEs (n = 70, 6.2%). In response to PRI, 41.7% of patients documented a reduction of at least one other pain medication and 30.8% even the complete cessation of any other pharmacological pain treatments. CONCLUSION: 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.

Prevalence of drug-induced constipation and severity of associated biopsychosocial effects in patients with nonmalignant pain: a cross-sectional review of depersonalized data from the German Pain e-Registry.

BACKGROUND: 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. OBJECTIVE: To assess the prevalence and impact of DIC in patients with NMP. METHODS: Exploratory noninterventional, retrospective, cross-sectional analysis of depersonalized routine data of the German Pain e-Registry on 150,488 NMP patients (EUPAS identifier: 42286). RESULTS: 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%. CONCLUSIONS: 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.

Tapentadol prolonged release in patients with chronic low back pain: real-world data from the German Pain eRegistry.

Aim: Comparison of tapentadol prolonged release (PR) with other oral WHO-III PR opioid analgesics (morphine, oxycodone ± naloxone, hydromorphone) in routine medical care of chronic low back pain. Patients & methods: Noninterventional, retrospective 12-week study using anonymized clinical practice data from the German Pain eRegistry. Six effectiveness, tolerability, and safety criteria were aggregated in a primary composite end point (treatment responder). Propensity scoring matched 2331 datasets per treatment cohort. Results: All six single criteria showed significantly better outcomes for tapentadol PR (all parameters p < 0.001). There were significantly more treatment responders under tapentadol PR (65.7 vs 14.2%; p < 0.001). Conclusion: Tapentadol PR showed significantly better effectiveness and tolerability in severe chronic low back pain unsuccessfully treated with WHO-I/II analgesics compared with the other oral WHO-III PR opioids investigated.

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.

[Real-life efficacy and tolerability of methocarbamol in patients suffering from refractory muscle-related low/back pain - Results of a health care research project based on data from the German pain practice registry]. / Wirksamkeit und Verträglichkeit von Methocarbamol bei muskulär bedingten subakuten Kreuz-/Rückenschmerzen : Ergebnisse eines Versorgungsforschungsprojektes unter Verwendung von Daten des DGS-PraxisRegister Schmerz.

BACKGROUND: 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. METHOD: 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). RESULTS: 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 p < 0.001 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 (p < 0,001). Overall, seven patients recorded eight minor treatment-related adverse events, which all resolved spontaneously during treatment without any specific countermeasures. CONCLUSION: 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.

Treatment for chronic low back pain: the focus should change to multimodal management that reflects the underlying pain mechanisms.

Chronic low back pain: Chronic pain is the most common cause for people to utilize healthcare resources and has a considerable impact upon patients' lives. The most prevalent chronic pain condition is chronic low back pain (CLBP). CLBP may be nociceptive or neuropathic, or may incorporate both components. The presence of a neuropathic component is associated with more intense pain of longer duration, and a higher prevalence of co-morbidities. However, many physicians' knowledge of chronic pain mechanisms is currently limited and there are no universally accepted treatment guidelines, so the condition is not particularly well managed. DIAGNOSIS: Diagnosis should begin with a focused medical history and physical examination, to exclude serious spinal pathology that may require evaluation by an appropriate specialist. Most patients have non-specific CLBP, which cannot be attributed to a particular cause. It is important to try and establish whether a neuropathic component is present, by combining the findings of physical and neurological examinations with the patient's history. This may prove difficult, however, even when using screening instruments. Multimodal management: The multifactorial nature of CLBP indicates that the most logical treatment approach is multimodal: i.e. integrated multidisciplinary therapy with co-ordinated somatic and psychotherapeutic elements. As both nociceptive and neuropathic components may be present, combining analgesic agents with different mechanisms of action is a rational treatment modality. Individually tailored combination therapy can improve analgesia whilst reducing the doses of constituent agents, thereby lessening the incidence of side effects. CONCLUSIONS: This paper outlines the development of CLBP and the underlying mechanisms involved, as well as providing information on diagnosis and the use of a wide range of pharmaceutical agents in managing the condition (including NSAIDs, COX-2 inhibitors, tricyclic antidepressants, opioids and anticonvulsants), supplemented by appropriate non-pharmacological measures such as exercise programs, manual therapies, behavioral therapies, interventional pain management and traction. Surgery may be appropriate in carefully selected patients.

A holistic approach to chronic pain management that involves all stakeholders: change is needed.

Chronic pain affects a large proportion of the population, imposing significant individual distress and a considerable burden on society, yet treatment is not always instituted and/or adequate. Comprehensive multidisciplinary management based on the biopsychosocial model of pain has been shown to be clinically effective and cost-efficient, but is not widely available. A literature review of stakeholder groups revealed many reasons for this, including: i) many patients believe healthcare professionals lack relevant knowledge, and consultations are rushed, ii) general practitioners consider that pain management has a low priority and is under-resourced, iii) pain specialists cite non-adherence to evidence-based treatment, sub-optimal prescribing, and chronic pain not being regarded as a disease in its own right, iv) nurses', pharmacists' and physiotherapists' skills are not fully utilized, and v) psychological therapy is employed infrequently and often too late. Many of the issues relating to physicians could be addressed by improving medical training, both at undergraduate and postgraduate levels - for example, by making pain medicine a compulsory core subject of the undergraduate medical curriculum. This would improve physician/patient communication, increase the use of standardized pain assessment tools, and allow more patients to participate in treatment decisions. Patient care would also benefit from improved training for other multidisciplinary team members; for example, nurses could provide counseling and follow-up support, psychologists offer coping skills training, and physiotherapists have a greater role in rehabilitation. Equally important measures include the widespread adoption of a patient-centered approach, chronic pain being recognized as a disease in its own right, and the development of universal guidelines for managing chronic non-cancer pain. Perhaps the greatest barrier to improvement is lack of political will at both national and international level. Some powerful initiatives and collaborations are currently lobbying policy-making bodies to raise standards and reduce unnecessary pain - it is vital they continue.

Pain in the cancer patient: different pain characteristics CHANGE pharmacological treatment requirements.

Twenty years ago, the main barriers to successful cancer pain management were poor assessment by physicians, and patients' reluctance to report pain and take opioids. Those barriers are almost exactly the same today. Cancer pain remains under-treated; in Europe, almost three-quarters of cancer patients experience pain, and almost a quarter of those with moderate to severe pain do not receive any analgesic medication. Yet it has been suggested that pain management could be improved simply by ensuring that every consultation includes the patient's rating of pain, that the physician pays attention to this rating, and a plan is agreed to increase analgesia when it is inadequate. After outlining current concepts of carcinogenesis in some detail, this paper describes different methods of classifying and diagnosing cancer pain and the extent of current under-treatment. Key points are made regarding cancer pain management. Firstly, the pain may be caused by multiple different mechanisms and therapy should reflect those underlying mechanisms - rather than being simply based on pain intensity as recommended by the WHO three-step ladder. Secondly, a multidisciplinary approach is required which combines both pharmacological and non-pharmacological treatment, such as psychotherapy, exercise therapy and electrostimulation. The choice of analgesic agent and its route of administration are considered, along with various interventional procedures and the requirements of palliative care. Special attention is paid to the treatment of breakthrough pain (particularly with fast-acting fentanyl formulations, which have pharmacokinetic profiles that closely match those of breakthrough pain episodes) and chemotherapy-induced neuropathic pain, which affects around one third of patients who receive chemotherapy. Finally, the point is made that medical education should place a greater emphasis on pain therapy, both at undergraduate and postgraduate level.

Managing chronic pain in elderly patients requires a CHANGE of approach.

In many countries, the number of elderly people has increased rapidly in recent years and this is expected to continue; it has been predicted that almost a quarter of the population in the European Union will be over 65 years of age in 2035. Many elderly people suffer from chronic pain but it is regularly under-treated, partly because managing these patients is often complex. This paper outlines the extent of untreated pain in this population and the consequent reduction in quality of life, before articulating the reasons why it is poorly or inaccurately diagnosed. These include the patient's unwillingness to complain, atypical pain presentations, multiple morbidities and cognitive decline. Successful pain management depends upon accurate diagnosis, which is based upon a complete history and thorough physical examination, as well as an assessment of psychosocial functioning. Poor physician/patient communication can be improved by using standardized instruments to establish individual treatment targets and measure progress towards them. User-friendly observational instruments may be valuable for patients with dementia. In line with the widely accepted biopsychosocial model of pain, a multidisciplinary approach to pain management is recommended, with pharmacotherapy, psychological support, physical rehabilitation and interventional procedures available if required. Declining organ function and other physiological changes require lower initial doses of analgesics and less frequent dosing intervals, and the physician must be aware of all medications that the patient is taking, in order to avoid drug/drug interactions. Non-adherence to treatment is common, and various strategies can be employed to improve it; involving the elderly patient's caregivers and family, using medication systems such as pill-boxes, or even sending text messages. In the long term, the teaching of pain medicine needs to be improved--particularly in the use of opioids--both at undergraduate level and after qualification.

Patients' and physicians' perspectives on opioid therapy for chronic cancer and musculoskeletal pain in Germany, Italy, and Turkey: PAin RESearch (PARES) survey.

OBJECTIVE: Under-treatment or lack of appropriate treatment for chronic pain remains an ongoing major healthcare problem. Opioids are being increasingly recognized as an effective option for chronic pain management. The objective of this survey was to understand the perspective of patients treated with opioids on quality of treatment, preferences, and possibilities to improve treatment and communication between patients and physicians. RESEARCH DESIGN: A large-scale PAin RESearch (PARES) survey of 2860 patients (Germany, Italy, and Turkey) with chronic cancer or musculoskeletal pain prescribed opioid therapy was conducted to assess various factors such as ease of use and compliance, sleep, quality-of-life, and polymedication. A physician component was also included. Relationships between variables and differences between groups were tested using Spearman and Wilcoxon signed-rank tests, respectively. RESULTS: Of the patients surveyed, 61% received strong opioids (WHO III) and 39% weak opioids (WHO II). Nearly 65% of the patients were currently on a twice daily or more dosing schedule; however, 61.5% of the patients responded that they considered once-daily dosing to be the most convenient schedule. Patients' responses indicated that different dosing schedules significantly influenced the occurrence of end-of-dose pain, feeling limited by the remaining level of pain, problems in falling asleep, and episodes of waking up at night or early in the morning. Physicians' responses showed that they were not surprised by 68.5% of patient responses; they also felt the need to change some aspect of pain treatment for a third of the patients, the commonest being pain medication (52.4%). CONCLUSIONS: The results of the survey suggest that patients prefer a convenient dosing scheme, which may have a positive impact on compliance. Physicians may have to communicate more closely with patients about their needs.

The development of chronic pain: physiological CHANGE necessitates a multidisciplinary approach to treatment.

Chronic pain is currently under-diagnosed and under-treated, partly because doctors' training in pain management is often inadequate. This situation looks certain to become worse with the rapidly increasing elderly population unless there is a wider adoption of best pain management practice. This paper reviews current knowledge of the development of chronic pain and the multidisciplinary team approach to pain therapy. The individual topics covered include nociceptive and neuropathic pain, peripheral sensitization, central sensitization, the definition and diagnosis of chronic pain, the biopsychosocial model of pain and the multidisciplinary approach to pain management. This last section includes an example of the implementation of a multidisciplinary approach in Belgium and describes the various benefits it offers; for example, the early multidimensional diagnosis of chronic pain and rapid initiation of evidence-based therapy based on an individual treatment plan. The patient also receives continuity of care, while pain relief is accompanied by improvements in physical functioning, quality of life and emotional stress. Other benefits include decreases in catastrophizing, self-reported patient disability, and depression. Improved training in pain management is clearly needed, starting with the undergraduate medical curriculum, and this review is intended to encourage further study by those who manage patients with chronic pain.

Low-dose 7-day transdermal buprenorphine in daily clinical practice - perceptions of elderly patients with moderate non-malignant chronic pain.

OBJECTIVE: To assess patients' perceptions regarding the low-dose 7-day buprenorphine transdermal patch for treatment of moderate non-malignant chronic pain. METHODS: Patient-reported outcome data were collected in clinical practices in Germany in a prospective, multicenter, non-interventional observation using the German Pain Questionnaire/German Pain Diary. Questionnaires were completed by the patients without influence from the attending physician. Mean change in pain intensity (lowest, average, and highest pain intensity in the previous 24 h), changes in Hospital Anxiety and Depression Scale scores (HADS-A and HADS-D), in impairments of daily activities (modified pain disability index, mPDI), in quality of life (quality of life impairment by pain inventory, QLIP), and in overall burden of pain over a 12-week treatment period were evaluated. RESULTS: Data of 891 patients were assessed (mean age 72.8 years). Buprenorphine starting doses were mainly 5 µg/h (67.1% of patients) and 10 µg/h (27.3%). At the end of week 12, the majority received either 5 µg/h (41%) or 10 µg/h (42.3%) buprenorphine. Mean average pain intensity was reduced by 5.1 points to 1.7 ± 1.3 from 6.8 ± 1.5 points at baseline (76% improvement). Amelioration was observed in HADS-A (59% from 7.8 ± 3.3 at baseline) and HADS-D (56% from 9.2 ± 3.1), in mPDI sum score (76%; from 31.1 ± 9.8), and in quality of life (165%; from 13.9 ± 10.1). Mean burden of pain continuously decreased. LIMITATIONS: All those inherent in open-label observations and pain studies using subjective and patient-reported outcome parameters (such as the lack of a control group). CONCLUSIONS: Our results indicate that the 7-day buprenorphine patch might be considered an effective treatment option for moderate non-malignant chronic pain management in daily clinical practice. The mostly elderly patient population of this patient survey experienced sustained pain relief and improvements in pain-related impairments of daily activities and quality of life, leading to a substantial reduction in overall burden of pain.

Dynamic risk factors in the misuse of opioid analgesics.

OBJECTIVE: Identify the risk factors for prescription opioid misuse among patients taking prescription opioids to deal with chronic pain. METHODS: We examined the literature for a variety of dynamic risk factors associated with opioid misuse among the chronic pain population in order to present a narrative review. Considered were: taking single or multiple opioids, pain intensity, mental health disorders, including a history of preadolescent sexual abuse, personal and familial history of substance abuse, a history of legal problems, being a crime victim, drug-seeking behaviors, drug craving, and age. RESULTS: A variety of risk factors have been studied in the literature. Risk factors in chronic opioid therapy patients are dynamic in that they can change with disease progression, tolerance, changes in pain quality, mental health, comorbidities, other drug therapies or drug interactions, and changes in the patient's lifestyle. CONCLUSION: Opioid analgesic therapy must be tailored to carefully monitor all patients in order to minimize misuse and abuse, since the risk is constant and dynamic and therefore every patient is at some degree of risk for opioid misuse.

Patient perceptions associated with the 5% lidocaine medicated plaster in daily practice.

OBJECTIVE: To evaluate patients' perceptions of 5% lidocaine medicated plaster for treatment of chronic neuropathic pain in daily clinical practice. RESEARCH DESIGN AND METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Stated preferences of physicians and chronic pain sufferers in the use of classic strong opioids.

We conducted a two-stage study in France, Germany, Italy, Spain, Sweden, and the United Kingdom of the stated preferences of chronic pain sufferers treated with classic strong opioids and of physicians treating such patients. The qualitative stage identified attributes perceived important through focus groups with 84 pain sufferers and semistructured interviews with 11 physicians. The quantitative stage included online, discrete choice experiments (DCEs) in which respondents chose between hypothetical profiles or an opt-out in 15 choice tasks. The profile descriptions were based on the attributes elicited in the qualitative stage. DCEs were conducted for pain sufferers (N = 242) and physicians (N = 270) who passed a rationality test. Main-effects models were estimated by hierarchical Bayesian regression. Sufferers ranked nausea, pain impact, energy, alertness, and constipation; physicians ranked pain response, central nervous system (CNS) effects, nausea, dose form, and constipation in descending order of importance. Sufferers were unwilling to incur severe side effects to decrease pain and chose the opt-out in approximately one half of the choice tasks, whereas physicians were willing to trade between profiles. The models predicted physicians' choices better than those of pain sufferers. No age, sex, or country effects were seen, but stronger preferences were found among physicians treating noncancer (n = 40) than cancer pain and among the 55% of sufferers who had never discontinued long-term pain medication use. Sufferers' mean pain scores on an 11-point Likert scale were 4.0, 5.7, and 8.6 on their best, average, and worst days, respectively.

The chronic pain conundrum: should we CHANGE from relying on past history to assessing prognostic factors?

BACKGROUND: Despite limited empirical support, chronic pain has traditionally been defined mainly on the basis of its duration, which takes no account of the causative mechanisms or its clinical significance. SCOPE: For this commentary on current pain management practice, the CHANGE PAIN Advisory Board considered the evidence for adopting a prognostic definition of chronic pain. The rationale underlying this approach is to take psychological and behavioural factors into account, as well as the multidimensional nature of pain. Measures of pain intensity, interference with everyday activities, role disability, depression, duration and number of pain sites are used to calculate a risk score, which indicates the likelihood of a patient having pain in the future. The consistency of a prognostic definition with the concept of integrated patient care was also considered. FINDINGS: When this method was compared with the number of pain days experienced over the previous 6 months--in patients with back pain, headache or orofacial pain--it was a better predictor of clinically significant pain 6 months later for all three pain conditions. Further evidence supporting this approach is that several factors other than the duration of pain have been shown to be important prognostic indicators, including unemployment, functional disability, anxiety and self-rated health. The use of a multifactorial risk score may also suggest specific measures to improve outcomes, such as addressing emotional distress. These measures should be undertaken as part of an integrated pain management strategy; chronic pain is a biopsychosocial phenomenon and all aspects of the patient's pain must be dealt with appropriately and simultaneously for treatment to be effective. CONCLUSION: The implementation of a prognostic definition and wider adoption of integrated care could bring significant advantages. However, these measures require improved training in pain management and structural revision of specialist facilities, for which political support is essential.

Proceedings of the CHANGE PAIN Expert Summit in Rome, June 2010.

Chronic non-cancer pain - unlike acute pain, which can be regarded as a symptom of disease or injury - is gaining recognition as a disease in its own right. It is a burden for the individual sufferer that has a severe impact on physical and social functioning. Chronic back pain, in particular, is a highly prevalent condition that has a considerable economic impact on society. However, treatment approaches for severe chronic non-cancer pain differ widely. The CHANGE PAIN initiative aims to enhance the understanding of patients who suffer from severe chronic pain and to improve pain management. The following special supplement, consisting of 10 commentaries, describes the proceedings from the first international Expert Meeting of the CHANGE PAIN initiative, which was held in Rome on June 20th and 21st, 2010.