Optimising treatment expectations in chronic lower back pain through observing others: a study protocol for a randomised clinical trial

IntroductionChronic lower back pain (CLBP) is a frequent cause of medical consultations worldwide, and it results in decreased quality of life and disability. Current treatments for CLBP are often not effective, and alternatives are urgently needed. Three promising possibilities have emerged: (1) open-label placebo treatment reduces chronic pain, (2) placebo treatment is as efficacious as opioid treatment with a high correlation between patient expectation and treatment outcome, and (3) observing positive effects in another patient can improve functional capacity. We hypothesise that treatment expectations can be positively influenced through social observation and improve treatment outcome.Methods and analysisIn our clinical trial, we will randomise patients with CLBP into five groups. Two groups receive either a 3 week course of treatment with an analgesic (ANA) (metamizole/dipyrone) or with open-label placebos (OLP). For one of each group, we will build treatment expectations through observational learning and assess its impact on the treatment. For this purpose, one group each will watch either a positive or a neutral video. The intervention groups will be compared with a control group that will not be given any medication or observational learning. Participants will be recruited via all institutions in the Hamburg metropolitan area that treat patients with CLBP. Patients are eligible for inclusion if they are at least 18 years or older, have CLBP (of at least 3 months duration), and agree to potentially receive an active ANA or an OLP. Patients with pain-related “red flags” will be excluded. The study requires 150 participants (30 participants per group) to assess the differences in the primary outcome, pain intensity. Secondary outcomes include changes in treatment expectations, anxiety, comorbid depression, stress-related neuroendocrine measures, functional and structural connectivity, functional capacity, and ANA consumption. All outcomes and treatment expectations will be measured before and after the intervention and 3 months post-intervention.Ethics and disseminationEthical approval was obtained in January 2020 from the Hamburg Medical Ethics Council (ref number PV7067). Outcomes will be disseminated through publications in peer-reviewed journals and presentations at national and international conference meetings.Trial registration numberThe approved trial protocol was registered at the German Clinical Trials Register (DRKS) and can be found at drks.de (Identifier: DRKS00024418).

A krónikus derékfájdalom korszerű diagnosztikája és kezelése a nemzetközi irányelvek tükrében

Összefoglaló. Nemzetközi kutatások szerint a deréktáji fájdalom 2019-ben 568 millió embert érintett világszerte. Magyarországon a lakosság 20%-a él krónikus derékfájdalommal, ami nemcsak egészségügyi, de szociális és ökonómiai krízist is jelent. A probléma aktualitását jól mutatja az is, hogy a Nemzetközi Fájdalomkutatási Társaság a 2021. évet a derékfájdalomról szóló globális évnek kiáltotta ki. A derékfájdalmak megfelelő kezelése és a krónikussá válás megelőzése tehát kiemelten fontos. Ebben nyújthatnak segítséget az evidenciákon alapuló irányelvek. Magyarországon azonban jelenleg nincs hatályos, egységes irányelv, mely a derékfájdalmakkal, azon belül is a krónikus derékfájdalom kezelésével foglalkozna. A jelen közleményben a krónikus derékfájdalom evidenciákon alapuló diagnosztikai és kezelési lehetőségeinek áttekintését tűztük ki célul. Az irodalomkutatást követően, a jelenleg is hatályos, AGREE II. rendszer szerinti magas minőségű besorolást elérő, krónikus deréktáji fájdalomra vonatkozó, angol nyelvű nemzetközi irányelvek ajánlásainak összehasonlítását végeztük el. Tanulmányunkban hét irányelvet dolgoztunk fel (négy európai, kettő amerikai, egy kanadai), melyek mindegyikében a következő közös ajánlások kerültek megfogalmazásra: a súlyos patológiák kizárása az alarm tünetek alapján, a pszichoszociális tényezők figyelembevétele, a szükségtelen képalkotó vizsgálat visszaszorítása, az elsősorban aktív, nem gyógyszeres terápiák preferálása és a nemszteroid gyulladáscsökkentők körültekintő felírása. Az európai irányelvekben új elemként szerepelt a krónikussá válás korai rizikóbecslése. Orv Hetil. 2021; 162(49): 1951–1961. Summary. In 2019, low back pain caused the highest burden globally, among musculoskeletal disorders, affecting 568 million people. According to Hungarian sociodemographic data, 20% of the Hungarian adults live with chronic low back pain that is a global health priority. Therefore, the International Association for the Study of Pain announced 2021 as the global year about back pain. Evidence-based guidelines about the appropriate treatment of acute low back pain and prevention of chronic low back pain are therefore of paramount importance. However, there are currently no valid, uniform treatment guidelines in Hungary about acute and chronic lower back pain. In this paper, we aimed at summarizing up-to-date, evidence-based diagnostic and treatment recommendations for chronic low back pain. Using a literature review, we identified seven international treatment guidelines (four from Europe, two from the United States and one from Canada) in English for the management of chronic low back pain that were previously assessed by the AGREE II quality assessment tool. We found consistent recommendations in the guidelines such as exclusion of alarm symptoms, assessment of psycho-social factors, reduction of unnecessary imaging, initialization of primarily active, non-pharmacological therapies, and careful and cautious prescription of non-steroidal anti-inflammatory medications. A new recommendation in the European guidelines is the early risk assessment of low back pain becoming chronic. Orv Hetil. 2021; 162(49): 1951–1961.

Machine Learning Approaches to Predict Chronic Lower Back Pain in People Aged over 50 Years

Background and Objectives: Chronic lower back pain (LBP) is a common clinical disorder. The early identification of patients who will develop chronic LBP would help develop preventive measures and treatment. We aimed to develop machine learning models that can accurately predict the risk of chronic LBP. Materials and Methods: Data from the Sixth Korea National Health and Nutrition Examination Survey conducted in 2014 and 2015 (KNHANES VI-2, 3) were screened for selecting patients with chronic LBP. LBP lasting >30 days in the past 3 months was defined as chronic LBP in the survey. The following classification models with machine learning algorithms were developed and validated to predict chronic LBP: logistic regression (LR), k-nearest neighbors (KNN), naïve Bayes (NB), decision tree (DT), random forest (RF), gradient boosting machine (GBM), support vector machine (SVM), and artificial neural network (ANN). The performance of these models was compared with respect to the area under the receiver operating characteristic curve (AUROC). Results: A total of 6119 patients were analyzed in this study, of which 1394 had LBP. The feature selected data consisted of 13 variables. The LR, KNN, NB, DT, RF, GBM, SVM, and ANN models showed performances (in terms of AUROCs) of 0.656, 0.656, 0.712, 0.671, 0.699, 0.660, 0.707, and 0.716, respectively, with ten-fold cross-validation. Conclusions: In this study, the ANN model was identified as the best machine learning classification model for predicting the occurrence of chronic LBP. Therefore, machine learning could be effectively applied in the identification of populations at high risk of chronic LBP.

Health disparities in chronic back pain and associated mortality seen in ischemic cardiac disease: a commentary

Prescription opioid use for nonmalignant chronic pain has grown in the US over the last decade. Those with chronic back pain have a higher risk of mortality from ischemic heart disease than those without. Studies have demonstrated a higher prevalence of cardiac disease in adults who report chronic pain. In addition, there is research that supports some association with pain sites and cardiovascular morbidity. Studies have also shown a high-grade chronic neck pain to be more associated with cardiovascular conditions when compared to moderate or low-grade chronic pain. Given this information, it is important to assess pain medication burden present in those who have a diagnosis of coronary artery disease and chronic lower back pain.

Understanding whether chronic lower back pain patients with lumbar spinal stenosis benefit from multiple epidural steroid injections prior to the mild® Procedure

Originally published in Pain Management, this article is a summary of a study performed to look at the benefit, if any, of more than one epidural steroid injection in the spine before the mild® Procedure. Minimally invasive lumbar decompression (commonly known as the mild Procedure) and epidural steroid injections are both common treatment options for lumbar spinal stenosis (commonly referred to as LSS), a condition that causes chronic lower back pain in older adults. To determine how to best treat LSS patients, healthcare professionals use a guide to help with the decision-making process (called an algorithm) to pass through non-medical to more invasive therapies that often includes one or more epidural steroid injections. An epidural steroid injection is medication inserted in the lower back to reduce swelling and provide relief from pain. Researchers wanted to look at a change to when in the treatment process the mild Procedure is carried out. In the study, researchers compared the medical records of participants who had received either just one or no steroid injection prior to the mild Procedure, to participants who received two or more epidural steroid injections prior to the mild Procedure. Similar outcomes in both treatment groups in this study proved that giving more than one epidural steroid injection prior to the mild Procedure did not improve how well patients did and may have delayed patient care. Based on the results of the study, it is recommended that the standard treatment process for LSS patients be changed to give the mild Procedure either as soon as LSS is diagnosed or after the failure of the first epidural steroid injection.

Association between Relative Handgrip Strength and Chronic Lower Back Pain: A Nationwide Cross-Sectional Analysis of the Korea National Health and Nutrition Examination Survey

Lower back pain (LBP) is the most common musculoskeletal complaint and significantly reduces the quality of life. Muscle weakness is a major cause of LBP. Handgrip strength (HGS) is widely used to determine general muscle strength. Relative HGS (RHGS) incorporates body mass and provides a more accurate estimation of muscle strength and health status. We analyzed the data from Korea National Health and Nutrition Examination Survey to investigate the association between RHGS and chronic LBP. We identified 14,930 participants and excluded a total of 9553 participants with age < 50 years, with incomplete LBP information, and with incomplete HGS information. We analyzed the data of 5377 participants: 1086 (20.19%) with chronic LBP and 4291 (79.8%) without chronic LBP. Multivariate regression analysis with adjustment for covariates identified an association between weak RHGS and chronic LBP (odds ratio 1.31; CI 1.07–1.61; p = 0.01). This article demonstrated a significant association between RHGS and chronic LBP. Therefore, RHGS should be measured for patients with chronic LBP.

Monoclonal Antibodies for Chronic Pain Treatment: Present and Future

Chronic pain remains a major problem worldwide, despite the availability of various non-pharmacological and pharmacological treatment options. Therefore, new analgesics with novel mechanisms of action are needed. Monoclonal antibodies (mAbs) are directed against specific, targeted molecules involved in pain signaling and processing pathways that look to be very effective and promising as a novel therapy in pain management. Thus, there are mAbs against tumor necrosis factor (TNF), nerve growth factor (NGF), calcitonin gene-related peptide (CGRP), or interleukin-6 (IL-6), among others, which are already recommended in the treatment of chronic pain conditions such as osteoarthritis, chronic lower back pain, migraine, or rheumatoid arthritis that are under preclinical research. This narrative review summarizes the preclinical and clinical evidence supporting the use of these agents in the treatment of chronic pain.

Differences in dynamic and postural stability based on degree of disability in patients with nonspecific chronic lower back pain: an observational study

Objetive: The main objective of this study was to analyze whether there were differences in dynamic balance and postural stability in relation to the level of disability in patients with chronic low back pain. Methodss: This is an observational study in which 60 patients with nonspecific chronic low back pain were included. All patients received a sociodemographic questionnaire, the visual analogue scale (VAS) and a series of self-reported psychological scales. To complete the evaluation, physical tests were performed in which dynamic balance and postural stability were measured. Results: Student’s t-test revealed that there were significant differences between the groups in dynamic balance with the right leg and the left leg. In contrast, there were no significant differences between the groups for the reach functional test in forward direction, left direction and right direction. Conclusion: In conclusion, our study demonstrates that patients with chronic low back pain with high levels of disability present significantly poorer dynamic balance compared with those with low levels of disability. In contrast, no significant differences were found between the groups in terms of static stability.