Exercise therapy for treatment of acute non-specific low back pain: a Cochrane systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the effectiveness of exercise for acute non-specific low back pain (LBP) versus our main comparisons: 1) sham treatment, and 2) no treatment at short-term (main follow-up time). DATA SOURCES AND STUDY SELECTION: A comprehensive search up till November 2021 was conducted in numerous databases for randomised controlled trials (RCTs) on the effectiveness of exercise in adults with acute LBP (< 6 weeks). Studies examining LBP with a specific aetiology were excluded. The primary outcomes were back pain, back-specific functional status and recovery. DATA EXTRACTION: Two review authors independently conducted the study selection, risk of bias assessment and data extraction. GRADE was used to assess the certainty of the evidence. DATA SYNTHESIS: We identified 23 RCTs (2674 participants). There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain (mean difference (MD) -0.80, 95% confidence interval (CI) -5.79 to 4.19; 1 study, 299 participants) and on functional status (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants) in the short term. There is very low-quality evidence which suggests no difference in effect on pain and functional status for exercise vs. no treatment (2 studies; n=157, not pooled due to heterogeneity) at short-term follow-up. Similar results were found for the other follow-up moments. The certainty of the evidence was downgraded because many RCTs had a high risk of bias, were small in size and/or there was substantial heterogeneity. CONCLUSION: Exercise therapy compared to sham/placebo and no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy.

Exercise therapy for treatment of acute non-specific low back pain.

BACKGROUND: Low back pain (LBP) is the leading cause of disability globally. It generates considerable direct costs (healthcare) and indirect costs (lost productivity). The many available treatments for LBP include exercise therapy, which is practised extensively worldwide. OBJECTIVES: To evaluate the benefits and harms of exercise therapy for acute non-specific low back pain in adults compared to sham/placebo treatment or no treatment at short-term, intermediate-term, and long-term follow-up. SEARCH METHODS: This is an update of a Cochrane Review first published in 2005. We conducted an updated search for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We screened the reference lists of all included studies and relevant systematic reviews published since 2004. SELECTION CRITERIA: We included RCTs that examined the effects of exercise therapy on non-specific LBP lasting six weeks or less in adults. Major outcomes for this review were pain, functional status, and perceived recovery. Minor outcomes were return to work, health-related quality of life, and adverse events. Our main comparisons were exercise therapy versus sham/placebo treatment and exercise therapy versus no treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We evaluated outcomes at short-term follow-up (time point within three months and closest to six weeks after randomisation; main follow-up), intermediate-term follow-up (between nine months and closest to six months), and long-term follow-up (after nine months and closest to 12 months); and we used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 23 studies (13 from the previous review, 10 new studies) that involved 2674 participants and provided data for 2637 participants. Three small studies are awaiting classification, and four eligible studies are ongoing. Included studies were conducted in Europe (N = 9), the Asia-Pacific region (N = 9), and North America (N = 5); and most took place in a primary care setting (N = 12), secondary care setting (N = 6), or both (N = 1). In most studies, the population was middle-aged and included men and women. We judged 10 studies (43%) at low risk of bias with regard to sequence generation and allocation concealment. Blinding is not feasible in exercise therapy, introducing performance and detection bias. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain scores in the short term (mean difference (MD) -0.80, 95% confidence interval (CI) -5.79 to 4.19; 1 study, 299 participants). The absolute difference was 1% less pain (95% CI 4% more to 6% less), and the relative difference was 4% less pain (95% CI 20% more to 28% less). The mean pain score was 20.1 (standard deviation (SD) 21) for the intervention group and 20.9 (SD 23) for the control group. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on functional status scores in the short term (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants). The absolute difference was 2% worse functional status (95% CI 2% better to 6% worse), and the relative difference was 15% worse (95% CI 17% better to 47% worse). The mean functional status score was 15.3 (SD 19) for the intervention group and 13.3 (SD 18) for the control group. We downgraded the certainty of the evidence for pain and functional status by one level for risk of bias and by two levels for imprecision (only one study with fewer than 400 participants). There is very low-certainty evidence that exercise therapy compared with no treatment has no clinically relevant effect on pain or functional status in the short term (2 studies, 157 participants). We downgraded the certainty of the evidence by two levels for imprecision and by one level for inconsistency. One study associated exercise with small benefits and the other found no differences. The first study was conducted in an occupational healthcare centre, where participants received one exercise therapy session. The other study was conducted in secondary and tertiary care settings, where participants received treatment three times per week for six weeks. We did not pool data from these studies owing to considerable clinical heterogeneity. In two studies, there were no reported adverse events. One study reported adverse events unrelated to exercise therapy. The remaining studies did not report whether any adverse events had occurred. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy. AUTHORS' CONCLUSIONS: Exercise therapy compared to sham/placebo treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Exercise therapy compared to no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. We downgraded the certainty of the evidence to very low for inconsistency, risk of bias concerns, and imprecision (few participants).

Completeness of Reporting Is Suboptimal in Randomized Controlled Trials Published in Rehabilitation Journals, With Trials With Low Risk of Bias Displaying Better Reporting: A Meta-research Study.

OBJECTIVE: Primary: To evaluate the completeness of reporting of randomized controlled trials (RCTs) published in rehabilitation journals through the evaluation of the adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist and investigate the relationship between reporting and risk of bias (ROB). Secondary: To study the association between completeness of reporting and the characteristics of studies and journals. DATA SOURCES: A random sample of 200 RCTs published between 2011 and 2020 in 68 rehabilitation journals indexed under the "rehabilitation" category in the InCites Journal Citation Report. STUDY SELECTION: One reviewer evaluated the completeness of reporting operationalized as the adherence to the CONSORT checklist. Two independent reviewers evaluated the ROB using the Cochrane risk-of-bias 2.0 tool. DATA EXTRACTION: Overall adherence and adherence to each CONSORT section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (quartile range, publication modalities, study protocol registration). DATA SYNTHESIS: The mean overall CONSORT adherence across studies was 65%. Studies with high ROB have less adherence than those with low ROB (-5.5%; CI, -10.9 to 0.0). There was a 10.2% (% CI, 6.2-14.3) increase in adherence if the RCT protocol was registered. Studies published in first quartile journals displayed an overall adherence of 11.7% (% CI 17.1-6.4) higher than those published in the fourth quartile. CONCLUSIONS: Reporting completeness is still suboptimal and is associated with ROB, journal impact ranking, and registration of the study protocol. Trial authors should improve adherence to the CONSORT guideline, and journal editors should adopt new strategies to improve the reporting.

The association between social exclusion or inclusion and health in EU and OECD countries: a systematic review.

BACKGROUND: Social exclusion (SE), or the inability to participate fully in society, is considered one of the driving forces of health inequalities. Systematic evidence on this subject is pertinent but scarce. This review aims to systematically summarise peer reviewed studies examining the association between the multidimensional concepts of SE and social inclusion (SI) and health among adults in EU and OECD countries. METHODS: The protocol was registered on Prospero (CRD42017052718). Three major medical databases were searched to identify studies published before January 2018, supplemented by reference and citation tracking. Articles were included if they investigated SE or SI as a multidimensional concept with at least two out of the four dimensions of SE/SI, i.e. economic, social, political and cultural. A qualitative synthesis was conducted. RESULTS: Twenty-two observational studies were included. In the general population, high SE/low SI was associated with adverse mental and general health. For physical health, the evidence was inconclusive. In groups at high risk of SE, support was found for the association between high SE/low SI and adverse mental health but no conclusions could be drawn for physical and general health. CONCLUSIONS: This review found evidence for the association between high SE/low SI and adverse health outcomes, particularly mental health outcomes. The evidence is mainly based on cross-sectional studies using simple and often ad hoc indicators of SE/SI. The development and use of validated measures of SE/SI and more longitudinal research is needed to further substantiate the evidence base and gain better understanding of the causal pathways.

Public support for smoke-free private indoor and public outdoor areas in the Netherlands: A trend analysis from 2018-2022.

INTRODUCTION: In addition to smoke-free policies in indoor public and workplaces, governments increasingly implement smoke-free policies at beaches, in parks, playgrounds and private cars ('novel smoke-free policies'). An important element in the implementation of such policies is public support. In the context of the ambition of the Netherlands to reach a smoke-free generation by 2040, we investigated temporal changes in public support for novel smoke-free policies. METHODS: We analyzed annual cross-sectional questionnaires in a representative sample of the Dutch population from 2018 to 2022. Multivariable logistic regression was applied to model public support for each smoke-free policy area as a function of time (calendar year), smoking status, gender, and socioeconomic status. Interaction terms were added for time with smoking status and with socioeconomic status. RESULTS: A total of 5582 participant responses were included. Between 2018 and 2022, support increased most for smoke-free policies regarding train platforms (+16%), theme parks (+12%), beaches (+10%), and terraces (+10%). In 2022, average support was higher than 65% for all categories of smoke-free places and highest for private cars with children (91%). Regression analyses indicated significant increases in support over time within each category of smoke-free places (adjusted odds ratio, AOR between 1.09 and 1.17 per year), except smoke-free private cars with children (AOR=0.97; 95% CI: 0.89-1.05). Regardless of smoking status, support was high for places where children often go. CONCLUSIONS: Support for novel smoke-free places in the Netherlands is high and increasing, in particular for places frequented by children. This indicates the potential to implement such measures in the Netherlands.

The effect of a comprehensive lifestyle intervention on cardiovascular risk factors in pharmacologically treated patients with stable cardiovascular disease compared to usual care: a randomised controlled trial.

BACKGROUND: The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established.The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD) compared with usual care. METHODS: A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71) or control group (n = 75) using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication. RESULTS: The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference). In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor. CONCLUSIONS: Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive lifestyle intervention had a beneficial effect on some cardiovascular risk factors. In the present era of cardiovascular therapy and with the increasing numbers of overweight and physically inactive patients, this study confirms the importance of risk factor control through lifestyle modification as a supplement to more intensified drug treatment in patients with CVD. TRIAL REGISTRATION: ISRCTN69776211 at http://www.controlled-trials.com.

The contribution of work and lifestyle factors to socioeconomic inequalities in self-rated health ‒ a systematic review.

Objective This study aimed to systematically review the literature on the contribution of work and lifestyle factors to socioeconomic inequalities in self-rated health among workers. Methods A search for cross-sectional and longitudinal studies assessing the contribution of work and/or lifestyle factors to socioeconomic inequalities in self-rated health among workers was performed in PubMed, PsycINFO and Web of Science in March 2017. Two independent reviewers performed eligibility and risk of bias assessment. The median change in odds ratio between models without and with adjustment for work or lifestyle factors across studies was calculated to quantify the contribution of work and lifestyle factors to health inequalities. A best-evidence synthesis was performed. Results Of those reviewed, 3 high-quality longitudinal and 17 cross-sectional studies consistently reported work factors to explain part (about one-third) of the socioeconomic health inequalities among workers (grade: strong evidence). Most studies separately investigated physical and psychosocial work factors. In contrast with the 12 cross-sectional studies, 2 longitudinal studies reported no separate contribution of physical workload and physical work environment to health inequalities. Regarding psychosocial work factors, lack of job resources (eg, less autonomy) seemed to contribute to health inequalities, whereas job demands (eg, job overload) might not. Furthermore, 2 longitudinal and 4 cross-sectional studies showed that lifestyle factors explain part (about one-fifth) of the health inequalities (grade: strong evidence). Conclusions The large contribution of work factors to socioeconomic health inequalities emphasizes the need for future longitudinal studies to assess which specific work factors contribute to health inequalities.

Motives for (not) participating in a lifestyle intervention trial.

BACKGROUND: Non-participants can have a considerable influence on the external validity of a study. Therefore, we assessed the socio-demographic, health-related, and lifestyle behavioral differences between participants and non-participants in a comprehensive CVD lifestyle intervention trial, and explored the motives and barriers underlying the decision to participate or not. METHODS: We collected data on participants (n = 50) and non-participants (n = 50) who were eligible for inclusion in a comprehensive CVD lifestyle interventional trial. Questionnaires and a hospital patient records database were used to assess socio-demographic, health-related and lifestyle behavioral variables. Univariate and multivariate logistic regression was used to describe the relationship between explanatory variables and study participation. Furthermore, motives and barriers that underlie study participation were investigated by means of questionnaires. RESULTS: Participants were younger, single, had a higher level of education and were employed. No statistically significant differences were found in health measures and behavioral variables. The motives for participation that were most frequently reported were: the perception of being unhealthy and willingness to change their lifestyle. The main barriers reported by non-participants were financial arguments and time investment. CONCLUSION: The differences between participants and non-participants in a lifestyle intervention trial are in mainly demographic factors. The participants consent in order to alter their lifestyle, and/or because they want to improve their health. To minimize non-participation, it is recommended that access to a lifestyle intervention program should be easy and cause no financial restraints. TRIAL REGISTRATION: ISRCTN69776211.

Shift work is associated with reduced heart rate variability among men but not women.

BACKGROUND: Imbalance in the autonomic nervous system due to a disrupted circadian rhythm may be a cause of shift work-related cardiovascular diseases. OBJECTIVE: We aimed to determine the association between shift work and cardiac autonomic activity in blue-collar workers. METHODS: The study included 665 blue-collar workers aged 18-68 years in different occupations from two Danish cohort studies. Time and frequency domain parameters of heart rate variability (HRV) were measured during sleep using the Actiheart monitor, and used as markers of cardiac autonomic function. Multiple linear regression analyses were used to investigate differences in HRV between day and shift workers. RESULTS: Shift workers had no significantly different HRV parameters than day workers, except for a lower VLF (B: 0.21; 95% CI: -0.36-0.05). The lower VLF was only present among non-night shift workers (p < 0.05) and not among night shift workers (p > 0.05). Results differed significantly by gender (p for interaction < 0.10): among men, shift work was negatively associated with RMSSD (B: -7.83; 95% CI: -14.28-1.38), SDNN (B: -7.0; 95% CI: -12.27-1.78), VLF (B: -0.27; 95% CI: -0.46-0.09) and Total Power (B: -0.61; 95% CI: -1.20-0.03), while among women, shift work was only associated with the LF/HF ratio (B: -0.29; 95% CI: -0.54-0.03). CONCLUSION: Shift work was particularly associated with lower HRV during sleep among men. This indicates that shift work causes imbalance in the autonomic nervous system among men, which might increase their risk of cardiovascular diseases.