Search

Importance: The effects of altered neural processing, defined as altering neural networks responsible for perceptions of pain and function, on chronic pain remains unclear.Objective: To estimate the effect of a graded sensorimotor retraining intervention (RESOLVE) on pain intensity in people with chronic low back pain.Design, Setting, and Participants: This parallel, 2-group, randomized clinical trial recruited participants with chronic (>3 months) nonspecific low back pain from primary care and community settings. A total of 276 adults were randomized (in a 1:1 ratio) to the intervention or sham procedure and attention control groups delivered by clinicians at a medical research institute in Sydney, Australia. The first participant was randomized on December 10, 2015, and the last was randomized on July 25, 2019. Follow-up was completed on February 3, 2020.Interventions: Participants randomized to the intervention group (n = 138) were asked to participate in 12 weekly clinical sessions and home training designed to educate them about and assist them with movement and physical activity while experiencing lower back pain. Participants randomized to the control group (n = 138) were asked to participate in 12 weekly clinical sessions and home training that required similar time as the intervention but did not focus on education, movement, and physical activity. The control group included sham laser and shortwave diathermy applied to the back and sham noninvasive brain stimulation.Main Outcomes and Measures: The primary outcome was pain intensity at 18 weeks, measured on an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]) for which the between-group minimum clinically important difference is 1.0 point.Results: Among 276 randomized patients (mean [SD] age, 46 [14.3] years; 138 [50%] women), 261 (95%) completed follow-up at 18 weeks. The mean pain intensity was 5.6 at baseline and 3.1 at 18 weeks in the intervention group and 5.8 at baseline and 4.0 at 18 weeks in the control group, with an estimated between-group mean difference at 18 weeks of -1.0 point ([95% CI, -1.5 to -0.4]; P = .001), favoring the intervention group.Conclusions and Relevance: In this randomized clinical trial conducted at a single center among patients with chronic low back pain, graded sensorimotor retraining, compared with a sham procedure and attention control, significantly improved pain intensity at 18 weeks. The improvements in pain intensity were small, and further research is needed to understand the generalizability of the findings.Trial Registration: ANZCTR Identifier: ACTRN12615000610538. [ABSTRACT FROM AUTHOR]

Background: Antidepressant medicines are used to manage symptoms of low back pain. The efficacy, acceptability, and safety of antidepressant medicines for low back pain (LBP) are not clear. We aimed to evaluate the efficacy, acceptability, and safety of antidepressant medicines for LBP. Methods: We searched CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, the EU Clinical Trials Register, and the WHO International Clinical Trial Registry Platform from inception to May 2020. We included published and trial registry reports of RCTs that allocated adult participants with LBP to receive an antidepressant medicine or a placebo medicine. Pairs of authors independently extracted data in duplicate. We extracted participant characteristics, study sample size, outcome values, and measures of variance for each outcome. We data using random-effects meta-analysis models and calculated estimates of effects and heterogeneity for each outcome. We formed judgments of confidence in the evidence in accordance with GRADE. We report our findings in accordance with the PRISMA statement. We prespecified all outcomes in a prospectively registered protocol. The primary outcomes were pain intensity and acceptability. We measured pain intensity at end-of-treatment on a 0–100 point scale and considered 10 points the minimal clinically important difference. We defined acceptability as the odds of stopping treatment for any reason. Results: We included 23 RCTs in this review. Data were available for pain in 17 trials and acceptability in 14 trials. Treatment with antidepressants decreased pain intensity by 4.33 points (95% CI − 6.15 to − 2.50) on a 0–100 scale, compared to placebo. Treatment with antidepressants increased the odds of stopping treatment for any reason (OR 1.27 [95% CI 1.03 to 1.56]), compared to placebo. Conclusions: Treatment of LBP with antidepressants is associated with small reductions in pain intensity and increased odds of stopping treatment for any reason, compared to placebo. The effect on pain is not clinically important. The effect on acceptability warrants consideration. These findings provide Level I evidence to guide clinicians in their use of antidepressants to treat LBP. Trial registration: We prospectively registered the protocol for this systematic review on PROSPERO (CRD42020149275). [ABSTRACT FROM AUTHOR]

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. We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results. This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial. ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619). [ABSTRACT FROM AUTHOR]

Massage and acupressure are not candidate treatments for rib fracture, just as joint manipulation and exercise are not appropriate options for hip fracture. B TO THE EDITOR: b We noted that the American College of Physicians' guideline on nonpharmacologic and pharmacologic management of acute pain from non-low back, musculoskeletal injuries ([1]) was informed by a network meta-analysis (NMA) ([2]). This NMA questioned what the best treatment was for patients with this condition and concluded that nonopioid drugs showed the "most convincing and attractive benefit-harm ratio for patients with acute pain from non-low back, musculoskeletal injuries.". [Extracted from the article]

Mediation analysis is a common statistical method used to investigate mechanisms of health exposure and interventions. The reporting quality of mediation studies used in randomised controlled trials has been considered heterogeneous and incomplete. The reporting quality of mediation analysis in observational studies is unknown. We conducted a systematic review to describe the reporting standards of recently published observational studies that used mediation analysis to understand the mechanism of health exposures. We searched for studies published between June 2017 and June 2019 indexed in EMBASE, MEDLINE and PsycINFO. Two reviewers screened articles and selected a random sample of 50 eligible studies for inclusion. We included studies across 13 healthcare fields and ten different health conditions. Most studies (74%) collected data on healthy individuals to assess their risk of developing a health disorder. Psychosocial and behavioural factors (self-control, self-esteem, alcohol consumption, pain) were the most prevalent exposures (n = 30, 60%), outcomes (n = 23, 46%) and mediators (n = 29, 58%). Most studies used a cross-sectional design (64%, n = 32), and a few studies reported sample size calculations (4%, n = 8). In 20% (n = 10) of the studies, adjustment for confounders was reported. Only 10% (n = 5) of studies reported the assumptions underlying the mediation analysis, and 14% (n = 7) of studies conducted some sensitivity analysis to assess the degree which unmeasured confounders would affect the estimate of the mediation effect. Mediation analysis is a common method used to investigate mechanisms in prevention research. The reporting of mediation analysis in observational studies is incomplete and may impact reproducibility, evidence synthesis and implementation. [ABSTRACT FROM AUTHOR]

Background: There is limited evidence for the comparative effectiveness of analgesic medicines for adults with low back pain. This systematic review and network meta-analysis aims to determine the analgesic effect, safety, acceptability, effect on function, and relative rank according to analgesic effect, safety, acceptability, and effect on function of a single course of [an] analgesic medicine(s) or combination of these medicines for people with low back pain. Methods: We will include published and unpublished randomised trials written in any language that compare an analgesic medicine to either another medicine, placebo/sham, or no intervention in adults with low back pain, grouped according to pain duration: acute (fewer than 6 weeks), sub-acute (6 to 12 weeks), and chronic (greater than 12 weeks). The co-primary outcomes are pain intensity following treatment and safety (adverse events). The secondary outcomes are function and acceptability (all-cause dropouts). We will perform a network meta-analysis to compare and rank analgesic medicines. We will form judgements of confidence in the results using the Confidence in Network Meta-Analysis (CINeMA) methodology. Discussion: This network meta-analysis will establish which medicine, or combination of medicines, is most effective for reducing pain and safest for adults with low back pain. Systematic review registration: PROSPERO CRD42019145257 [ABSTRACT FROM AUTHOR]

An improved understanding of the biopsychosocial influences that contribute to and maintain pain has promoted the development of new efficacious treatments for chronic low back pain (CLBP). This study aimed to investigate the mechanisms of a new treatment—education and graded sensorimotor retraining—on pain and disability. We conducted a preplanned causal mediation analysis of a randomized clinical trial which allocated 276 participants with CLBP to 12 weekly clinical sessions of education and graded sensorimotor retraining (n = 138) or a sham and attention control (n = 138). Outcomes were pain intensity and disability, both assessed at 18 weeks. Hypothesized mediators included tactile acuity, motor coordination, back self-perception, beliefs about the consequences of back pain, kinesiophobia, pain self-efficacy, and pain catastrophizing, all assessed at the end of treatment (12 weeks). Four of 7 mechanisms (57%) mediated the intervention effect on pain; the largest mediated effects were for beliefs about back pain consequences (−0.96 [−1.47 to −0.64]), pain catastrophizing (−0.49 [−0.61 to −0.24]), and pain self-efficacy (−0.37 [−0.66 to −0.22]). Five of 7 mechanisms (71%) mediated the intervention effect on disability; the largest mediated effects were for beliefs about back pain consequences (−1.66 [−2.62 to −0.87]), pain catastrophizing (−1.06 [−1.79 to −0.53]), and pain self-efficacy (−0.84 [−1.89 to −0.45]). When all 7 mechanisms were considered simultaneously, the joint mediation effect explained most of the intervention effect for both pain and disability. Optimizing interventions to target beliefs about the consequences of back pain, pain catastrophizing, and pain self-efficacy is likely to lead to improved outcomes for people with CLBP. [ABSTRACT FROM AUTHOR]

Introduction: Low back pain contributes to an increasing global health burden exacerbated by unsustained improvements from current treatments. There is a need to develop, and test interventions to maintain initial improvements from low back pain treatments. One option is to implement a booster intervention. This study aimed to develop and test the feasibility of implementing a booster intervention delivered remotely to supplement the benefits from a complex intervention for chronic low back pain. Method: This study was nested in the RESOLVE trial. The booster intervention was developed by an expert group, including a clinical psychologist, exercise physiologist and physiotherapists, and based on a motivational interviewing framework. We developed a conversational flow chart to support the clinician to guide participants towards achieving their pre‐specified personal goals and future low back pain self‐management. Participants with chronic low back pain who were aged over 18 years and fluent in English were recruited. The booster intervention was delivered in one session, remotely, by telephone. The intervention was considered feasible if: participants were able to be contacted or <3 contacts were necessary to arrange the booster session; there were sufficient willing participants (<15% of sample unwilling to participate); and participants and research clinicians reported a perceived benefit of >7/10. Results: Fifty participants with chronic non‐specific low back pain were recruited to test the feasibility of implementing the booster intervention. Less than three contact attempts were necessary to arrange the booster session, only one participant declined to participate. Participants perceived the session to be beneficial; on a 0 to 10 scale of perceived benefit, the average score recorded was 8.3 (SD 2.0). Clinicians also reported a moderate perceived benefit to the participant; the average score recorded by clinicians was 6.3 (SD 1.6). Conclusion: We developed a step by step, simple booster intervention that was perceived to be beneficial to participants with chronic low back pain. The booster can feasibly be delivered remotely following a complex intervention. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]