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Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control.

Scientific progress requires transparency and openness. The ability to critique, replicate and implement scientific findings depends on the transparency of the study design and methods, and the open availability of study materials, data and code. Journals are key stakeholders in supporting transparency and openness. This study aimed to evaluate 10 highest ranked pain journals’ authorship policies with respect to their support for transparent and open research practices. Two independent authors evaluated the journal policies (as at 27 May 2019) using three tools: the self-developed Transparency and Openness Evaluation Tool, the Centre for Open Science (COS) Transparency Factor and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosure of conflicts of interest. We found that the journal policies had an overall low level of engagement with research transparency and openness standards. The median COS Transparency Factor score was 3.5 (IQR 2.8) of 29 possible points, and only 7 of 10 journals’ stated requirements for disclosure of conflicts of interest aligned fully with the ICMJE recommendations. Improved transparency and openness of pain research has the potential to benefit all that are involved in generating and using research findings. Journal policies that endorse and facilitate transparent and open research practices will ultimately improve the evidence base that informs the care provided for people with pain.

The sacroiliac joint (SIJ) is often considered to be involved when people present for care with low back pain where SIJ is located. However, determining why the pain has arisen can be challenging, especially in the absence of a specific cause such as pregnancy, disease, or trauma, when the SIJ might be identified as a source of symptoms with the help of manual clinical tests. Nonspecific SIJ-related pain is commonly suggested to be causally associated with movement problems in the SIJ(s)-a diagnosis traditionally derived from manual assessment of movements of the SIJ complex. Management choices often consist of patient education, manual treatment, and exercise. Although some elements of management are consistent with guidelines, this Perspective article argues that the assumptions on which these diagnoses and treatments are based are problematic, particularly if they reinforce unhelpful, pathoanatomical beliefs. This article reviews the evidence regarding the clinical detection and diagnosis of SIJ movement dysfunction. In particular, it questions the continued use of assessing movement dysfunction despite mounting evidence undermining the biological plausibility and subsequent treatment paradigms based on such diagnoses. Clinicians are encouraged to align their assessment methods and explanatory models with contemporary science to reduce the risk of their diagnoses and choice of intervention negatively affecting clinical outcomes.

ObjectiveTo evaluate the comparative effectiveness and safety of analgesic medicines for acute non-specific low back pain.DesignSystematic review and network meta-analysis.Data sourcesMedline, PubMed, Embase, CINAHL, CENTRAL, ClinicalTrials.gov, clinicialtrialsregister.eu, and World Health Organization’s International Clinical Trials Registry Platform from database inception to 20 February 2022.Eligibility criteria for study selectionRandomised controlled trials of analgesic medicines (eg, non-steroidal anti-inflammatory drugs, paracetamol, opioids, anti-convulsant drugs, skeletal muscle relaxants, or corticosteroids) compared with another analgesic medicine, placebo, or no treatment. Adults (≥18 years) who reported acute non-specific low back pain (for less than six weeks).Data extraction and synthesisPrimary outcomes were low back pain intensity (0-100 scale) at end of treatment and safety (number of participants who reported any adverse event during treatment). Secondary outcomes were low back specific function, serious adverse events, and discontinuation from treatment. Two reviewers independently identified studies, extracted data, and assessed risk of bias. A random effects network meta-analysis was done and confidence was evaluated by the Confidence in Network Meta-Analysis method.Results98 randomised controlled trials (15 134 participants, 49% women) included 69 different medicines or combinations. Low or very low confidence was noted in evidence for reduced pain intensity after treatment with tolperisone (mean difference −26.1 (95% confidence intervals −34.0 to −18.2)), aceclofenac plus tizanidine (−26.1 (−38.5 to −13.6)), pregabalin (−24.7 (−34.6 to −14.7)), and 14 other medicines compared with placebo. Low or very low confidence was noted for no difference between the effects of several of these medicines. Increased adverse events had moderate to very low confidence with tramadol (risk ratio 2.6 (95% confidence interval 1.5 to 4.5)), paracetamol plus sustained release tramadol (2.4 (1.5 to 3.8)), baclofen (2.3 (1.5 to 3.4)), and paracetamol plus tramadol (2.1 (1.3 to 3.4)) compared with placebo. These medicines could increase the risk of adverse events compared with other medicines with moderate to low confidence. Moderate to low confidence was also noted for secondary outcomes and secondary analysis of medicine classes.ConclusionsThe comparative effectiveness and safety of analgesic medicines for acute non-specific low back pain are uncertain. Until higher quality randomised controlled trials of head-to-head comparisons are published, clinicians and patients are recommended to take a cautious approach to manage acute non-specific low back pain with analgesic medicines.Systematic review registrationPROSPERO CRD42019145257

•Facilitators/barriers to target the altered nervous system in chronic low back pain.•Effective pain communication creates positive attitudes and empowerment.•Some approaches increase while others interfere with intervention coherence.•Face-to-face and online components increase confidence in performing the treatment.•People outside the treatment team also impact the acceptability of the treatment.

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 letter. Inter-rater reliability and agreement of the TRUST form was assessed using intraclass correlation coefficients and the standard error of measurement, respectively. Time-based criteria, fidelity 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), reflecting low engagement with transparent 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.

ObjectiveTo investigate the efficacy, acceptability, and safety of muscle relaxants for low back pain.DesignSystematic review and meta-analysis of randomised controlled trials.Data sourcesMedline, Embase, CINAHL, CENTRAL, ClinicalTrials.gov, clinicialtrialsregister.eu, and WHO ICTRP from inception to 23 February 2021.Eligibility criteria for study selectionRandomised 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 synthesisTwo 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).Results49 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.ConclusionsConsiderable 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 registrationPROSPERO CRD42019126820 and Open Science Framework https://osf.io/mu2f5/.