Grunenthal (Spain)

Chronic pain (CP) is a public health problem worldwide. To update the prevalence of CP and compare the clinical and social characteristics of people with CP with those with non-chronic continuous pain and a group without pain. An observational cross-sectional study was carried out in a representative sample of 7058 adults from the Spanish population. Sociodemographic data, the presence of CP and non-chronic continuous pain, characteristics of pain, limitations on activities of daily living (ADL), the presence and level of anxiety and depression (HADS), quality of life (SF-12v2) and social support (DUKE) were collected. Descriptive and bivariate analyses were performed. The prevalence of CP was 25.9% (95% CI;24.8-26.9) and that of non-chronic continuous pain was 7.7% (95% CI;7.1-8.3). Women presented a higher prevalence of both CP (30.5% vs. 21.3%) and non-chronic continuous pain (8.8% vs. 6.6%). CP was more common in the group between 55 and 75 years old (30.6%, 95% CI = 28.6-32.6%), non-chronic continuous pain affected most the population between 18 and 34 years old (11.2%, 95% CI = 9.6-12.7%). The median duration of CP was 4 years. The lumbar was the most frequent pain site (58.1%), and 27.1% did not know the cause. A greater frequency of limitations on ADL, more anxiety and depression, and worse quality of life were shown among the subjects with CP. CP affects one in four Spanish people and impairs the mental, physical and social health. Differences exist by sex and age in its frequency. Identifying subjects with non-chronic continuous pain is fundamental to prevent their pain from becoming chronic. Indicating the main aspects where this work adds significantly to existing knowledge in the field, and if appropriate to clinical practice. Due to its high prevalence and impact on quality of life, chronic pain has become one of the main health problems nowadays. Attention must be paid to it both from a clinical and social perspective, trying to raise awareness among the population of its possible causes and consequences. In routine clinical practice, greater consideration is given to groups of people with a higher prevalence of chronic pain, such as women and people with middle age, and with no chronic pain to prevent the appearance of chronic pain.

To analyse the effectiveness of a physical exercise programme guided by a mobile health technology system (COVIDReApp) for patients with post-acute COVID-19 syndrome. This syndrome is a multisystem disease that occurs in people with a history of COVID-19 between 1 and 3 months after the onset of the disease. This study will assess the impact of the intervention on fatigue, post-exertional dyspnoea, quality of life, pain severity, physical fitness, anxiety, depression and cognitive function. We also aim to analyse whether there are associations between the variables studied and the evolution of these associations during follow-up. A single-blind randomised controlled trial. One hundred patients diagnosed with post-acute COVID-19 will be enrolled and randomly assigned to two groups. The experimental group will perform the intervention through a physical exercise programme guided by the COVIDReApp system, whereas the control group will perform the programme in paper format. Study outcomes will be collected at baseline and at 4, 12 and 24 weeks. Student's t-tests or Mann-Whitney U-tests will be used to analyse differences between groups, mixed ANOVA for differences over time and longitudinal structural equations for associations between variables at follow-up. This study is based on current evidence regarding exercise prescription recommendations for patients with post-acute COVID-19 syndrome. Our intervention is supported by a solid theoretical framework; however, challenges include tailoring the physical exercise programme to everyone's predominant symptoms and ensuring adherence to the programme. NCT05725538.

To compare cognitive function in patients with diabetes mellitus type-2 (T2DM) both with and without diabetic neuropathic pain (DNP). To analyse the relationship between mood and sleep disorders, quality of life and cognitive function in patients with DNP. Cross-sectional study conducted in patients with T2DM and neuropathy. The presence of DNP, cognitive function, mood status, sleep quality, health-related quality of life, pain intensity and phenotype of pain were measured. Descriptive, bivariate and multivariate analyses were performed. A total of 149 patients (71 with DNP) were included. Patients with and without DNP presented similar scores on the TYM (41.46; SD = 6.70 vs. 41.97; SD = 5.50) and those with DNP had a slightly higher frequency of cognitive impairment (TYM score ≤ 41: 40.8% vs. 43.6%). The patients without DNP performed better in the verbal fluency dimension (mean = 3.53; SD = 0.98 vs. mean = 3.82; SD = 0.66). Being older (B = − 0.258) and under treatment with insulin (B = − 2.919) were related with greater cognitive impairment. Obesity (OR = 17.277) and a longer duration of diabetes (OR = 1.317) were also related to greater risk of cognitive impairment. Impaired cognitive function in patients with DNP is more related to T2DM factors than pain factors. The presence of depression and a worse quality of life were related to a greater risk of cognitive impairment. Identifying and controlling these factors should be an essential intervention for maintaining the cognitive function in patients with T2DM and DNP.

BACKGROUND: The central analgesic tapentadol prolonged release (PR) has proven effective and generally well tolerated in a broad range of chronic pain conditions. Long-term data of its use are still scarce. OBJECTIVES: To evaluate long-term effectiveness, tolerability, and safety of tapentadol PR in patients with severe chronic osteoarthritis (OA) knee pain or low back pain (LBP) who responded to tapentadol in 1 of 4 preceding 12-week phase 3b clinical trials. STUDY DESIGN: Open-label, uncontrolled, observational extension study of up to 72 weeks. SETTING: Fourteen centers in Spain. Protocol approval by the reference ethics committee for all the participating centers. METHODS: Eligible patients started the extension trial on the tapentadol PR dosage optimized for them in the preceding trial; dose adjustments were permitted throughout the extension. Treatment effectiveness outcomes included changes in pain intensity, sleep, state of health, quality of life, patient and clinician global impression of change, and patients’ satisfaction with treatment. Patients with OA knee pain also answered the Western Ontario and McMaster Universities OA index, and patients with LBP with a possible neuropathic pain component completed neuropathic pain-related questionnaires. RESULTS: Eighty-three patients were enrolled: 40 with OA knee pain, 43 with LBP. The full analysis set consisted of 81 patients. Mean pain intensity remained relatively stable over the 72-week extension period with mean increases from baseline of 0.44 (95% confidence interval [CI], -0.1,1.0; Numeric Rating Scale) for all patients, 0.2 (95% CI, -0.5, 0.9) for patients with OA, and 0.68 (95% CI, -0.2, 1.6) for patients with LBP. State of health and quality of life baseline ratings were maintained; overall impression of change was “improved.” Most patients (88.9%) reported at least good treatment satisfaction at the end of treatment. Mean daily tapentadol PR doses slightly increased from 313.3 ± 139.5 mg at baseline to 315.7 ± 140.1 mg at end of study. Uptitration was required for 8.4% of the patients, 4.8% had a dose reduction during the trial. Adverse events considered probably/likely or certainly related to tapentadol PR treatment by the investigator were documented for 18.1% of all patients, most commonly constipation (7.2%). Seven patients (8.4%) experienced adverse events leading to premature discontinuation. LIMITATIONS: An open-label design, stable concomitant analgesics (World Health Organization step I), and dose adjustments were allowed during the study. All patients had benefitted from tapentadol PR in preceding trials. CONCLUSIONS: Sustained pain relief and quality of life for up to 72 treatment weeks under relatively stable dosing, as well as the good safety profile, indicate the usefulness of tapentadol PR for patients who suffer from severe chronic OA knee pain and LBP with limited risk for tolerance development. KEY WORDS: Tapentadol prolonged release, extension study, long-term, chronic pain, osteoarthritis, low back pain, efficacy, safety

The purpose of this study was to evaluate the construct validity and reliability of the Catalan version of the Pain Self-Efficacy Questionnaire (PSEQ) in a sample of young people with chronic pain. Two hundred twenty-seven young people with chronic pain (age range = 12-24 years, mean age = 17.87 years, SD = 3.08 years) participated in this study. The findings support a one-factor structure of the PSEQ, and the scale demonstrated excellent internal consistency reliability in our sample. In addition, convergent validity was supported by a loading of average variance extracted (AVE) greater than .50, and discriminant validity was supported by the finding that self-efficacy and pain-related anxiety AVEs were greater than the shared variance between both constructs. Further support for the measure's construct validity was shown by (1) significant and positive associations between PSEQ scores and adaptive coping strategies and (2) negative and significant associations between PSEQ scores and maladaptive coping strategies and catastrophizing thoughts. The results of this study indicate that the Catalan version of the PSEQ is reliable and valid when used to assess pain self-efficacy beliefs in young people with chronic pain.

Epidemiological data about neuropathic pain are still scarce. A national survey, based on neurologic clinical diagnosis, was performed to determine its prevalence among patients attending pain clinics. An epidemiological cross-sectional study involving pain clinics across all regions in Spain was carried out. Pain specialists evaluated the medical files and the clinical condition of patients attending their practices systematically during 1 day. They used the revised definition and grading system proposed in 2008 to decide whether a given patient had definite (i.e., confirmed), probable (potential) or possible (believed) neuropathic pain. Also, they provided a diagnostic label for neuropathic pain conditions and appraised treatment adequacy. In a single day, 178 pain specialists provided data from 2173 patients. Definite, probable and possible neuropathic pain was cited in 639 (29.4%), 304 (14.0%) and 97 (4.5%) patients, respectively. Almost two-thirds of these were women. A diagnostic label of primary pure central and/or peripheral neuropathic pain was cited in 344 (15.8%) patients. The most common diagnostic label (568 patients) was low back pain or sciatica causing mixed neuropathic pain. Definite neuropathic pain diagnosis was less likely in patients with mixed pain conditions and in women derived from primary care. Co-morbid depressive or anxiety symptoms were usual. Definite (confirmed) neuropathic pain alone was as prevalent as neuropathic pain ascertained with screening questionnaires in prior recent European studies. The clinical relevance of the surplus of patients with potential and believed neuropathic pain ascertained by clinicians is uncertain.

It has been suggested that low physical fitness is a contributor to pain in fibromyalgia and that exercise-related beliefs play a role in the persistence of this association. Yet the association between physical fitness and pain is hardly explored in detail. The aim of this exploratory study in patients with fibromyalgia was to investigate the association of physical fitness levels with self-reported and experimental pain as well as with pain catastrophizing and activity-avoidance beliefs. Physical fitness of 18 patients with fibromyalgia was examined using maximal ergocycling and the 6-minute walking test (6MWT). Pain intensity was assessed using self-report scales and quantitative sensory testing. A reduced walking distance on the 6MWT was correlated with more severe self-reported pain on the Fibromyalgia Impact Questionnaire (r = -0.52, P < 0.05). Recovery of heart rate after ergocycling was correlated with cold pain thresholds (r = 0.70, P < 0.01), pressure pain thresholds (r = -0.70, P < 0.01), and heat wind-up (r = 0.66, P < 0.05). Activity-avoidance beliefs correlated with a lower peak VO2 on the cycle test (r = -0.52, P < 0.05), a shorter distance on the 6MWT (r = -0.56, P < 0.05), and more severe self-reported pain (r = 0.61, P < 0.05), reflecting that patients with activity-avoidance beliefs were less physically fit and experienced more severe pain. The results demonstrate some associations between physical fitness and pain in fibromyalgia and point to the importance of activity avoidance. Although the causal directionality of the associations needs substantiation in clinical research, the findings support the notion that low fitness and activity-avoidance beliefs should be targeted while treating pain in fibromyalgia.

Objective:The relationship between chronic noncancer pain (CNCP) control and pain medication (analgesic) adherence has not been widely documented. The primary aim of this study was to evaluate the relationship between pain intensity and the degree of adherence to analgesic medication prescribed in pain clinics. There was also a special emphasis on the influence of polypharmacy on adherence.Methods:A cross-sectional clinical survey was carried out in pain clinics across Spain. Demographic and clinical data were collected from patients: pain intensity, analgesic prescription and adherence, and the presence of concomitant medical conditions and treatments. The relationship between analgesic adherence and pain intensity was analyzed using correlations and propensity scores based on ordinal logistic regression. Correlates of pain intensity were explored using multiple linear regression.Results:Data was gathered from 1407 patients; 1321 were eligible for analysis. Their mean (standard deviation) age was 61.6 (14.7) years and the majority (67.3%) were women. More than half (57.9%) received step 3 analgesics. Pain intensity was scored 5 out of 10 on average. Just 65.9% of patients were reported to not have missed any analgesic dose during the previous week. Pain intensity correlated negatively with analgesic adherence (rs = −0.151, p < 0.001). Moderate versus very intense pain was predicted in patients with ‘good’ and ‘very poor’ adherence, respectively. The presence of concomitant medications also correlated negatively with analgesic adherence (rs = −0.074, p = 0.007). However, few investigators reported such a negative effect of polypharmacy.Limitations:Key limitations of this research are its cross-sectional design and the absence of an objective means of measuring medication adherence.Conclusions:This study has shown that there is a small but significant inverse relationship between analgesic adherence and CNCP control, which has remained elusive to date and should be further evaluated. Polypharmacy also had a negative influence on adherence, although this was not acknowledged by all investigators.