The economic and humanistic costs of chronic lower back pain in Japan.
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ABSTRACT:
SUBMITTER: Montgomery W
PROVIDER: S-EPMC5491576 | biostudies-other | 2017
REPOSITORIES: biostudies-other
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Project description:Chronic lower back pain is a significant disease that affects nearly 20% of the worldwide population. Along with hindering patients' quality of life, chronic lower back pain is considered to be the second most common cause of disability among Americans. Treating chronic lower back pain is often a challenge for providers, especially in light of our current opioid epidemic. With this epidemic and an increased aging population, there is an imminent need for development of new pharmacologic therapeutic options, which are not only effective but also pose minimal adverse effects to the patient. With these considerations, a novel therapeutic agent called tanezumab has been developed and studied. Tanezumab is a humanized monoclonal immunoglobulin G2 antibody that works by inhibiting the binding of NGF to its receptors. NGF is involved in the function of sensory neurons and fibers involved in nociceptive transduction. It is commonly seen in excess in inflammatory joint conditions and in chronic pain patients. Nociceptors are dependent on NGF for growth and ongoing function. The inhibition of NGF binding to its receptors is a mechanism by which pain pathways can be interrupted. In this article, a number of recent randomized controlled trials are examined relating to the efficacy and safety of tanezumab in the treatment of chronic lower back pain. Although tanezumab was shown to be an effective pain modulator in major trials, several adverse effects were seen among different doses of the medication, one of which led to a clinical hold placed by the US Food and Drug Administration. In summary, tanezumab is a promising agent that warrants further investigation into its analgesic properties and safety profile.
| S-EPMC5825994 | biostudies-other
Project description:BACKGROUND:Societal costs of low back pain (LBP) are high, yet few studies have been performed to identify the predictive factors of high societal costs among chronic LBP patients. This study aimed to determine which factors predict high societal costs in patients with chronic LBP. METHODS:Data of 6,316 chronic LBP patients were used. In the main analysis, high societal costs were defined as patients in the top 10% of cost outcomes. Sensitivity analyses were conducted using patients in the top 5% and top 20% of societal costs. Potential predictive factors included patient expectations, demographic factors (e.g. age, gender, nationality), socio-economic factors (e.g. employment, education level) and health-related factors (e.g. body mass index [BMI], general health, mental health). The final prediction models were obtained using backward selection. The model's prognostic accuracy (Hosmer-Lemeshow X2 , Nagelkerke's R2 ) and discriminative ability (area under the receiver operating curve [AUC]) were assessed, and the models were internally validated using bootstrapping. RESULTS:Poor physical health, high functional disability, low health-related quality of life, high impact of pain experience, non-Dutch nationality and decreasing pain were found to be predictive of high societal costs in all models, and were therefore considered robust. After internal validation, the models' fit was good, their explained variance was relatively low (?14.1%) and their AUCs could be interpreted as moderate (?0.71). CONCLUSION:Future studies should focus on understanding the mechanisms associated with the identified predictors for high societal costs in order to design effective cost reduction initiatives. SIGNIFICANCE:Identifying low back pain patients who are at risk (risk stratification) of becoming high-cost users and making appropriate initiatives could help in reducing high costs.
| S-EPMC7003839 | biostudies-literature
Project description:OBJECTIVE:To evaluate the impact of pregabalin on sleep, pain, function, and health status in patients with chronic low back pain with accompanying neuropathic pain (CLBP-NeP) under routine clinical practice. METHODS:This prospective, non-interventional, observational study enrolled Japanese adults (?18 years) with CLBP-NeP of duration ?3 months and severity ?5 on a numerical rating scale (0= no pain, 10= worst possible pain). Treatment was 8 weeks with pregabalin (n=157) or usual care alone (n=174); choice of treatment was determined by the physician. The primary efficacy outcome was change from baseline to 8 weeks in pain-related interference with sleep, assessed using the Pain-Related Sleep Interference Scale (PRSIS; 0= did not interfere with sleep, 10= completely interferes with sleep). Secondary endpoints were changes in PRSIS at week 4, and changes at weeks 4 and 8 in pain (numerical rating scale), function (Roland-Morris Disability Questionnaire), and quality of life (EuroQol 5D-5L); global assessments of change were evaluated from the clinician and patient perspectives at the final visit. RESULTS:Demographic characteristics were similar between cohorts, but clinical characteristics suggested greater disease severity in the pregabalin group including a higher mean (standard deviation) pain score, 6.3 (1.2) versus 5.8 (1.1) (P<0.001). For the primary endpoint, pregabalin resulted in significantly greater improvements in PRSIS at week 8, least-squares mean changes of -1.3 versus -0.4 for usual care (P<0.001); pregabalin also resulted in greater PRSIS improvement at week 4 (P=0.012). Relative to usual care at week 8, pregabalin improved pain and function (both P<0.001), and showed global improvements since beginning study medication (P<0.001). Pregabalin was well tolerated. CONCLUSION:In clinical practice in patients with CLBP-NeP, pregabalin showed significantly greater improvements in pain-related interference with sleep relative to usual care. In addition, pregabalin significantly improved pain, function, and health status, suggesting the benefits of pregabalin for overall health and well-being relative to usual care in these patients. (Clinicaltrials. gov identifier NCT02273908).
| S-EPMC4531006 | biostudies-literature
Project description:In addition to the risk of developing opioid use disorder (OUD), known side-effects of long-term opioid use include chronic inflammation and hyperalgesia, which may arise from immune responses induced following chronic opioid use. To investigate this hypothesis, blood samples were obtained from individuals with chronic back pain who were either chronically taking prescription opioids or had minimal recent opioid exposure. Patient samples were analyzed using an enzyme-linked immunosorbent assay (ELISA) against hydrocodone- or oxycodone-hapten conjugates to assess the levels of antibodies present in the samples. While no specific response was seen in opioid-naïve subjects, we observed varying levels of anti-opioid IgM antibodies in the exposed subjects. In these subjects, antibody formation was found to be weakly correlated with current reported daily opioid dose. Other drugs of abuse found to elicit an immune response have been shown to generate advanced glycation end-products (AGEs) through reaction with glucose and subsequent modification of self-proteins. Investigations into this potential mechanism of anti-opioid antibody production identified reduced the formation of reactive intermediate species upon norhydrocodone reaction with glucose in comparison with nornicotine, thus identifying potentially important differences in hapten processing to yield the observed adaptive immune response.
| S-EPMC7551707 | biostudies-literature
Project description:Chronic pain is thought to affect patients' cognitive functioning, including attention. Loss of attention is likely to have an impact on the execution of daily tasks, and, therefore, to have negative effects. However, relationships between chronic pain and cognitive deficits are still debated. Pre-clinical studies using laboratory animals prove useful to model pain-related cognitive impairment, but animal models had to predict effects in the real world. This study investigates attentional engagement of domestic horses by comparing observations in a home setting and evaluations of vertebral disorders. We found that lower attentional engagement and the level of back disorders were correlated. Two different evaluation techniques of the state of horses' spines gave similar results. We suggest that novel animal models would prove useful for identifying spontaneous behaviours indicative of chronic pain. We suggest that more ethological studies in human patients' home environments would help to improve our understanding of the processes involved. Finally, these results yield interesting indications for evaluating animal welfare, as attentional engagement could become a reliable indicator of chronic pain and thus a useful tool for identification of suffering individuals.
| S-EPMC4731760 | biostudies-other
Project description:BackgroundAlthough mobile health (mHealth) interventions can help improve outcomes among patients with chronic lower back pain (CLBP), many available mHealth apps offer content that is not evidence based. Limbr was designed to enhance self-management of CLBP by packaging self-directed rehabilitation tutorial videos, visual self-report tools, remote health coach support, and activity tracking into a suite of mobile phone apps, including Your Activities of Daily Living, an image-based tool for quantifying pain-related disability.ObjectiveThe aim is to (1) describe patient engagement with the Limbr program, (2) describe patient-perceived utility of the Limbr program, and (3) assess the validity of the Your Activities of Daily Living module for quantifying functional status among patients with CLBP.MethodsThis was a single-arm trial utilizing a convenience sample of 93 adult patients with discogenic back pain who visited a single physiatrist from January 2016 to February 2017. Eligible patients were enrolled in 3-month physical therapy program and received the Limbr mobile phone app suite for iOS or Android. The program included three daily visual self-reports to assess pain, activity level, and medication/coping mechanisms; rehabilitation video tutorials; passive activity-level measurement; and chat-based health coaching. Patient characteristics, patient engagement, and perceived utility were analyzed descriptively. Associations between participant characteristics and program interaction were analyzed using multiple linear regression. Associations between Your Activities of Daily Living and Oswestry Disability Index (ODI) assessments were examined using Pearson correlation and hierarchical linear modeling.ResultsA total of 93 participants were enrolled; of these, 35 (38%) completed the program (age: mean 46, SD 16 years; female: 22/35, 63%). More than half of completers finished assessments at least every 3 days and 70% (19/27) used the rehabilitation component at least once a week. Among respondents to a Web-based feedback survey, 76% (16/21) found the daily notifications helped them remember to complete their exercises, 81% (17/21) found the system easy to use, and 62% (13/21) rated their overall experience good or excellent. Baseline Your Activities of Daily Living score was a significant predictor of baseline ODI score, with ODI increasing by 0.30 units for every 1-unit increase in Your Activities of Daily Living (P<.001). Similarly, hierarchical linear modeling analysis indicated that Your Activities of Daily Living daily assessment scores were significant predictors of ODI scores over the course of the study (P=.01).ConclusionsEngagement among participants who completed the Limbr program was high, and program utility was rated positively by most respondents. Your Activities of Daily Living was significantly associated with ODI scores, supporting the validity of this novel tool. Future studies should assess the effect of Limbr on clinical outcomes, evaluate its use among a wider patient sample, and explore strategies for reducing attrition.Trial registrationClinicalTrials.gov NCT03040310; https://clinicaltrials.gov/ct2/show/NCT03040310 (Archived by WebCite at http://www.webcitation.org/722mEvAiv).
| S-EPMC6231870 | biostudies-literature
Project description:Study designRetrospective observational study.ObjectivesThere is no consensus to predict improvement of lower back pain (LBP) in lumbar spinal stenosis after decompression surgery. The aim of this study was to evaluate the improvement of LBP and analyze the preoperative predicting factors for residual LBP.MethodsWe retrospectively reviewed 119 patients who underwent lumbar decompression surgery without fusion and had a minimum follow-up of 1 year. LBP was evaluated using the numerical rating scale (NRS), Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) LBP score, and Roland-Morris Disability Questionnaire (RMDQ). All patients were divided into LBP improved group (group I) and LBP residual group (group R) according to the NRS score. Radiographic images were examined preoperatively and at the final follow-up. We evaluated spinopelvic radiological parameters and analyzed the differences between group I and group R.ResultsLBP was significantly improved after decompression surgery (LBP NRS, 5.7 vs 2.6, P < .001; JOABPEQ LBP score, 41.3 vs 79.6, P < .001; RMDQ, 10.3 vs 3.6, P < .001). Of 119 patients, 94 patients were allocated to group I and 25 was allocated to group R. There was significant difference in preoperative thoracolumbar kyphosis between group I and group R.ConclusionsMost cases of LBP in lumbar spinal stenosis were improved after decompression surgery without fusion. Preoperative thoracolumbar kyphosis predicted residual LBP after decompression surgery.
| S-EPMC7882817 | biostudies-literature
Project description:ObjectiveWe applied natural language processing and inference methods to extract social determinants of health (SDoH) information from clinical notes of patients with chronic low back pain (cLBP) to enhance future analyses of the associations between SDoH disparities and cLBP outcomes.Materials and methodsClinical notes for patients with cLBP were annotated for 7 SDoH domains, as well as depression, anxiety, and pain scores, resulting in 626 notes with at least one annotated entity for 364 patients. We used a 2-tier taxonomy with these 10 first-level classes (domains) and 52 second-level classes. We developed and validated named entity recognition (NER) systems based on both rule-based and machine learning approaches and validated an entailment model.ResultsAnnotators achieved a high interrater agreement (Cohen's kappa of 95.3% at document level). A rule-based system (cTAKES), RoBERTa NER, and a hybrid model (combining rules and logistic regression) achieved performance of F1 = 47.1%, 84.4%, and 80.3%, respectively, for first-level classes.DiscussionWhile the hybrid model had a lower F1 performance, it matched or outperformed RoBERTa NER model in terms of recall and had lower computational requirements. Applying an untuned RoBERTa entailment model, we detected many challenging wordings missed by NER systems. Still, the entailment model may be sensitive to hypothesis wording.ConclusionThis study developed a corpus of annotated clinical notes covering a broad spectrum of SDoH classes. This corpus provides a basis for training machine learning models and serves as a benchmark for predictive models for NER for SDoH and knowledge extraction from clinical texts.
| S-EPMC10354762 | biostudies-literature
Project description:The aim of this study was to assess the economic cost of chronic pain among adolescents receiving interdisciplinary pain treatment. Information was gathered from 149 adolescents (ages 10-17) presenting for evaluation and treatment at interdisciplinary pain clinics in the United States. Parents completed a validated measure of family economic attributes, the Client Service Receipt Inventory, to report on health service use and productivity losses due to their child's chronic pain retrospectively over 12 months. Health care costs were calculated by multiplying reported utilization estimates by unit visit costs from the 2010 Medical Expenditure Panel Survey. The estimated mean and median costs per participant were $11,787 and $6,770, respectively. Costs were concentrated in a small group of participants; the top 5% of those patients incurring the highest costs accounted for 30% of total costs, whereas the lower 75% of participants accounted for only 34% of costs. Total costs to society for adolescents with moderate to severe chronic pain were extrapolated to $19.5 billion annually in the United States. The cost of adolescent chronic pain presents a substantial economic burden to families and society. Future research should focus on predictors of increased health services use and costs in adolescents with chronic pain.This cost of illness study comprehensively estimates the economic costs of chronic pain in a cohort of treatment-seeking adolescents. The primary driver of costs was direct medical costs followed by productivity losses. Because of its economic impact, policy makers should invest resources in the prevention, diagnosis, and treatment of chronic pediatric pain.
| S-EPMC4150826 | biostudies-other
Project description:IntroductionChronic lower back pain (CLBP) is problematic in older veterans. Spinal manipulative therapy (SMT) is commonly utilized for CLBP in older adults, yet there are few randomized placebo-controlled trials evaluating SMT.MethodsThe purpose of the study was to compare the effectiveness of SMT to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics.ResultsOlder veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 were included in the study with 69 being randomly assigned to SMT and 67 to sham intervention. Patients were treated 2 times per week for 4 weeks assessing outcomes at baseline, 5, and 12 weeks postbaseline. Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the SMT group when compared to the sham intervention group. There were no significant differences in adverse events between the groups.ConclusionsThe SMT did not result in greater improvement in pain when compared to our sham intervention; however, SMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.
| S-EPMC4252156 | biostudies-literature