Efficacy, acceptability, and safety of muscle relaxants for adults with non-specific low back pain : systematic review and meta-analysis

Abstract: Objective To investigate the efficacy, acceptability, and safety of muscle relaxants for low back pain. Design: Systematic review and meta-analysis of randomised controlled trials. Data sources: Medline, Embase, CINAHL, CENTRAL, ClinicalTrials.gov, clinicialtrialsregister.eu, and WHO ICTRP from inception to 23 February 2021. Eligibility criteria for study selection: Randomised controlled trials of muscle relaxants compared with placebo, usual care, waiting list, or no treatment in adults (≥18 years) reporting non-specific low back pain. Data extraction and synthesis: Two reviewers independently identified studies, extracted data, and assessed the risk of bias and certainty of the evidence using the Cochrane risk-of-bias tool and Grading of Recommendations, Assessment, Development and Evaluations, respectively. Random effects meta-analytical models through restricted maximum likelihood estimation were used to estimate pooled effects and corresponding 95% confidence intervals. Outcomes included pain intensity (measured on a 0-100 point scale), disability (0-100 point scale), acceptability (discontinuation of the drug for any reason during treatment), and safety (adverse events, serious adverse events, and number of participants who withdrew from the trial because of an adverse event). Results: 49 trials were included in the review, of which 31, sampling 6505 participants, were quantitatively analysed. For acute low back pain, very low certainty evidence showed that at two weeks or less non-benzodiazepine antispasmodics were associated with a reduction in pain intensity compared with control (mean difference -7.7, 95% confidence interval-12.1 to-3.3) but not a reduction in disability (-3.3, -7.3 to 0.7). Low and very low certainty evidence showed that non-benzodiazepine antispasmodics might increase the risk of an adverse event (relative risk 1.6, 1.2 to 2.0) and might have little to no effect on acceptability (0.8, 0.6 to 1.1) compared with control for acute low back pain, respectively. The number of trials investigating other muscle relaxants and different durations of low back pain were small and the certainty of evidence was reduced because most trials were at high risk of bias. Conclusions: Considerable uncertainty exists about the clinical efficacy and safety of muscle relaxants. Very low and low certainty evidence shows that non-benzodiazepine antispasmodics might provide small but not clinically important reductions in pain intensity at or before two weeks and might increase the risk of an adverse event in acute low back pain, respectively. Large, high quality, placebo controlled trials are urgently needed to resolve uncertainty. Systematic review registration PROSPERO CRD42019126820 and Open Science Framework https://osf.io/mu2f5/

Data Informing Governing Body Resistance-Training Guidelines Exhibit Sex Bias: An Audit-Based Review

The objective of this review was to examine the ratio of female and male participants utilised in data informing consensus statements and position stands in the field of resistance training (RT). In order to achieve this objective, we conducted an ‘audit’ style review. We accessed three databases: SPORTDiscus, MEDLINE and Google Scholar utilising the following search terms: resistance or strength training AND consensus statements or position statements/stands. Eligibility criteria included consensus statements and position stands for RT in youth, adults and older adults. In this paper we have used the term ‘female’ to describe biological sex. Gender is a social construct and often describes roles and behaviours that society assigns to men or women. In this paper we have used the term ‘women’ to describe gender. Reference lists from each guideline were screened with the number of male and female participants extracted from each study. We also extracted data on the gender of the authors of the statements. We located 11 guidelines encompassing a total of 104,251,363 participants. Youth guidelines were comprised of 69% male participants. There were 287 studies that included both sexes, 205 male-only and 92 female-only studies. Adult guidelines were comprised of 70% male participants. There were 104 studies that included both sexes, 240 male-only and 44 female-only studies. Older adult guidelines were comprised of 54% female participants. There were 395 studies that included both sexes, 112 male-only and 83 female-only studies. Women authors comprised 13% of all authors of position stands and consensus statements. These results demonstrate an under-representation of females and women as both participants and as authors. It is imperative to ensure that data informing governing body guidelines and consensus statements are representative of the population they aim to inform. If this is not possible, guidelines should clearly state when their data and recommendations are based primarily upon one sex

The effectiveness and safety of isometric resistance training for adults with high blood pressure: a systematic review and meta-analysis

High blood pressure (BP) is a global health challenge. Isometric resistance training (IRT) has demonstrated antihypertensive effects, but safety data are not available, thereby limiting its recommendation for clinical use. We conducted a systematic review of randomized controlled trials comparing IRT to controls in adults with elevated BP (systolic ≥130 mmHg/diastolic ≥85 mmHg). This review provides an update to office BP estimations and is the first to investigate 24-h ambulatory BP, central BP, and safety. Data were analyzed using a random-effects meta-analysis. We assessed the risk of bias with the Cochrane risk of bias tool and the quality of evidence with GRADE. Twenty-four trials were included (n = 1143; age = 56 ± 9 years, 56% female). IRT resulted in clinically meaningful reductions in office systolic (-6.97 mmHg, 95% CI -8.77 to -5.18, p p p = 0.02) but not 24-h systolic BP (-2.77 mmHg, 95% CI -6.80 to 1.25, p = 0.18). These results are very low/low certainty with high heterogeneity. There was no significant increase in the risk of IRT, risk ratio (1.12, 95% CI 0.47 to 2.68, p = 0.8), or the risk difference (1.02, 95% CI 1.00 to 1.03, p = 0.13). This means that there is one adverse event per 38,444 bouts of IRT. IRT appears safe and may cause clinically relevant reductions in BP (office, central BP, and 24-h diastolic). High-quality trials are required to improve confidence in these findings. PROSPERO (CRD42020201888); OSF (https://doi.org/10.17605/OSF.IO/H58BZ)

Interactive video games to improve pediatric procedural pain and anxiety: a systematic review and meta-analysis

Background: procedural pain and anxiety in children can be poorly controlled, leading to significant short and long-term sequelae such as longer procedure times or future healthcare avoidance. Caregiver anxiety can exacerbate these effects. We aimed to evaluate the effect of interactive video game interventions on children’s procedural pain and anxiety, including the effect of different types of video games on those outcomes. Methods: we conducted a systematic review and meta-analysis of the effectiveness of interactive video games compared to standard care in children (0-18 years) undergoing painful procedures. We searched the databases MEDLINE, Embase and PsycInfo. We conducted random-effects meta-analysis using ‘R’ of children’s procedural pain and anxiety, and caregivers’ anxiety. Results: of 2,185 studies screened, 36 were eligible (n=3,406 patients). Studies commonly involved venous access (33%) or day surgery (31%). Thirty-four studies were eligible for meta-analyses. Interactive video games appear to reduce children’s procedural pain (standardised mean difference = -0.43, 95% CI -0.67, -0.20) and anxiety (SMD = 0.61, 95% CI -0.88, -0.34), and caregivers’ procedural anxiety (SMD = -0.31, 95% CI -0.58, -0.04). We observed no difference between preparatory and distracting games, or between virtual reality and non-virtual reality games. We also observed no difference between interactive video games compared to standard care for most medical outcomes (e.g. procedure length), except a reduced need for restraint. Studies reported minimal adverse effects and typically had high intervention acceptability and satisfaction. Conclusions: our findings support introducing easily available video games such as distraction-based conventional video games into routine practice, to minimise paediatric procedural pain and child/caregiver anxiety

The smallest worthwhile effect on pain intensity of nonsteroidal anti-inflammatory drugs and exercise therapy for acute and chronic low back pain: a benefit-harm trade-off study

Question: What are the smallest worthwhile effects of nonsteroidal anti-inflammatory drugs (NSAIDs) for people with acute and chronic low back pain (LBP)? What is the smallest worthwhile effect of individualised exercise for people with chronic LBP compared with no intervention? Design: Benefit-harm trade-off study. Participants: Participants were recruited by advertisement on social media and included if they were English-speaking adults in Australia who had non-specific LBP. Outcome measure: Pain intensity. Results: A total of 116 people with acute LBP and 230 people with chronic LBP were recruited. For acute LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 30% (IQR 10 to 40%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 27.5% (IQR 10 to 50%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of exercise additional to no intervention was a 20% (IQR 10 to 40%) reduction in pain intensity. There were small associations between baseline pain, duration of pain and level of exercise and the smallest worthwhile effect of NSAIDs for acute LBP. There were no other clear associations. Conclusions: For people with LBP, the smallest worthwhile effect of exercise and NSAIDs additional to no intervention is approximately a 20 to 30% reduction in pain. These results can inform the interpretation of the effects of NSAIDs and exercise in randomised trials and meta-analyses, incorporating consumers’ perspectives. Further research on comparisons between different interventions and on other core LBP outcomes may inform decision-making. Registration: OSF osf.io/3erjx/

The smallest worthwhile effect on pain intensity of exercise therapy for people with chronic low back pain:a discrete choice experiment study

OBJECTIVE: To identify the smallest worthwhile effect (SWE) of exercise therapy for people with non-specific chronic low back pain (CLBP). DESIGN: Discrete choice experiment. METHODS: The SWE was estimated as the lowest reduction in pain that participants would consider exercising worthwhile, compared to not exercising i.e., effects due to natural history and other components (e.g., regression to the mean). We recruited English-speaking adults in Australia with non-specific CLBP to our online survey via email obtained from a registry of previous participants and advertisements on social media. We used discrete choice experiment to estimate the SWE of exercise compared to no exercise for pain intensity. We analysed the discrete choice experiment using a mixed logit model, and mitigated hypothetical bias through certainty calibration, with sensitivity analyses performed with different certainty calibration thresholds. RESULTS: Two-hundred and thirteen participants completed the survey. The mean age (±SD) was 50.7±16.5, median (IQR) pain duration 10 years (5-20), and mean pain intensity (±SD) was 5.8±2.3 on a 0-10 numerical rating scale. For people with CLBP the SWE of exercise was a between-group reduction in pain of 20%, compared to no exercise. In the sensitivity analyses, the SWE varied with different levels of certainty calibration; from 0% without certainty calibration to 60% with more extreme certainty calibration. CONCLUSION: This patient-informed threshold of clinical importance could guide the interpretation of findings from randomised trials and meta-analyses of exercise therapy compared to no exercise. </p

The smallest worthwhile effect on pain intensity of exercise therapy for people with chronic low back pain: a discrete choice experiment study.

OBJECTIVE: To identify the smallest worthwhile effect (SWE) of exercise therapy for people with non-specific chronic low back pain (CLBP). DESIGN: Discrete choice experiment. METHODS: The SWE was estimated as the lowest reduction in pain that participants would consider exercising worthwhile, compared to not exercising i.e., effects due to natural history and other components (e.g., regression to the mean). We recruited English-speaking adults in Australia with non-specific CLBP to our online survey via email obtained from a registry of previous participants and advertisements on social media. We used discrete choice experiment to estimate the SWE of exercise compared to no exercise for pain intensity. We analysed the discrete choice experiment using a mixed logit model, and mitigated hypothetical bias through certainty calibration, with sensitivity analyses performed with different certainty calibration thresholds. RESULTS: Two-hundred and thirteen participants completed the survey. The mean age (±SD) was 50.7±16.5, median (IQR) pain duration 10 years (5-20), and mean pain intensity (±SD) was 5.8±2.3 on a 0-10 numerical rating scale. For people with CLBP the SWE of exercise was a between-group reduction in pain of 20%, compared to no exercise. In the sensitivity analyses, the SWE varied with different levels of certainty calibration; from 0% without certainty calibration to 60% with more extreme certainty calibration. CONCLUSION: This patient-informed threshold of clinical importance could guide the interpretation of findings from randomised trials and meta-analyses of exercise therapy compared to no exercise

Feasibility of an audit and feedback intervention to facilitate journal policy change towards greater promotion of transparency and openness in sports science research

Objectives: To evaluate (1) the feasibility of an audit-feedback intervention to facilitate sports science journal policy  change, (2) the reliability of the Transparency of Research Underpinning Social Intervention Tiers (TRUST) policy  evaluation form, and (3) the extent to which policies of sports science journals support transparent and open research  practices. Methods: We conducted a cross-sectional, audit-feedback, feasibility study of transparency and openness standards  of the top 38 sports science journals by impact factor. The TRUST form was used to evaluate journal policies support  for transparent and open research practices. Feedback was provided to journal editors in the format of a tailored let‑ ter. Inter-rater reliability and agreement of the TRUST form was assessed using intraclass correlation coefcients and  the standard error of measurement, respectively. Time-based criteria, fdelity of intervention delivery and qualitative  feedback were used to determine feasibility. Results: The audit-feedback intervention was feasible based on the time taken to rate journals and provide tailored  feedback. The mean (SD) score on the TRUST form (range 0–27) was 2.05 (1.99), refecting low engagement with trans‑ parent and open practices. Inter-rater reliability of the overall score of the TRUST form was moderate [ICC (2,1)=0.68  (95% CI 0.55–0.79)], with standard error of measurement of 1.17. However, some individual items had poor reliability. Conclusion: Policies of the top 38 sports science journals have potential for improved support for transparent and  open research practices. The feasible audit-feedback intervention developed here warrants large-scale evaluation as a  means to facilitate change in journal policies </p