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BackgroundLow back pain (LBP) is the leading cause of years lived with disability worldwide. Most people with LBP receive the diagnosis of nonspecific LBP or sciatica. Medications are commonly prescribed but have limited analgesic effects and are associated with adverse events. A novel treatment approach is to target neurotrophins such as nerve growth factor (NGF) to reduce pain intensity. NGF inhibitors have been tested in some randomized controlled trials (RCTs) in recent years, showing promise for the treatment of chronic LBP; however, their efficacy and safety need to be evaluated to guide regulatory actions. ObjectiveThe aim of this study is to evaluate the efficacy and safety of medicines targeting neurotrophins in patients with LBP and sciatica. MethodsIn this systematic review, we will include published and unpublished records of parallel RCTs and the first phase of crossover RCTs that compare the effects of medicines targeting neurotrophins with any control group. We will search the CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, EU Clinical Trials Register, and WHO International Clinical Registry Platform databases from inception. Pairs of authors will independently screen the records for eligibility, and we will independently extract data in duplicate. We will conduct a quantitative synthesis (meta-analysis) with the studies that report sufficient data and compare the medicines of interest versus placebo. We will use random-effects models and calculate estimates of effects and heterogeneity for each outcome. We will assess the risk of bias for each study using the Cochrane Collaboration tool, and form judgments of confidence in the evidence according to GRADE recommendations. We will use the PRISMA statement to report the findings. We plan to conduct subgroup analyses by condition, type of medication, and time point. We will also assess the impact of a potential new trial on an existing meta-analysis. Data from studies that meet inclusion criteria but cannot be included in the meta-analysis will be reported narratively. ResultsThe protocol was registered on the Open Science Framework on May 19, 2020. As of December 2020, we have identified 1932 records. ConclusionsThis systematic review and meta-analysis will assess the evidence for the efficacy and safety of NGF inhibitors for pain in patients with nonspecific LBP and sciatica. The inclusion of new studies and unpublished data may improve the precision of the effect estimates and guide regulatory actions of the medications for LBP and sciatica. Trial RegistrationOpen Science Framework; https://osf.io/b8adn/ International Registered Report Identifier (IRRID)DERR1-10.2196/22905

Muscle volume must increase substantially during childhood growth to generate the power required to propel the growing body. One unresolved but fundamental question about childhood muscle growth is whether muscles grow at equal rates; that is, if muscles grow in synchrony with each other. In this study, we used magnetic resonance imaging (MRI) and advances in artificial intelligence methods (deep learning) for medical image segmentation to investigate whether human lower leg muscles grow in synchrony. Muscle volumes were measured in 10 lower leg muscles in 208 typically developing children (eight infants aged less than 3 months and 200 children aged 5 to 15 years). We tested the hypothesis that human lower leg muscles grow synchronously by investigating whether the volume of individual lower leg muscles, expressed as a proportion of total lower leg muscle volume, remains constant with age. There were substantial age‐related changes in the relative volume of most muscles in both boys and girls (p < 0.001). This was most evident between birth and five years of age but was still evident after five years. The medial gastrocnemius and soleus muscles, the largest muscles in infancy, grew faster than other muscles in the first five years. The findings demonstrate that muscles in the human lower leg grow asynchronously. This finding may assist early detection of atypical growth and allow targeted muscle‐specific interventions to improve the quality of life, particularly for children with neuromotor conditions such as cerebral palsy. [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]

Objectives This meta-analysis aims to investigate the efficacy and safety of medicines that target neurotrophic factors for low back pain (LBP) or sciatica. Methods We searched published and trial registry reports of randomized controlled trials evaluating the effect of medicines that target neurotrophic factors to LBP or sciatica in seven databases from inception to December 2020. Two reviewers independently identified studies, extracted data, and assessed the risk of bias and certainty in the evidence. Results Nine studies (3370 participants) were included in the meta-analyses. Low certainty evidence showed that anti-nerve growth factor (NGF) may reduce pain at 4 weeks (mean difference [MD] −6.75, 95% CI: −8.61, −4.90) and 12 weeks (MD −6.16, 95% CI: −8.38, −3.94), and may increase adverse effects for chronic LBP (odds ratio [OR] 1.18, 95% CI: 1.01, 1.38). Higher doses of anti-NGF may offer a clinically important reduction in pain at the cost of increased adverse effects for chronic LBP. Very low certainty evidence showed that anti-NGF and glial cell line-derived neurotrophic factor (pro-GDNF) may not reduce pain for sciatica at 4 weeks (MD −1.40, 95% CI: −8.26, 5.46), at 12 weeks (MD −2.91, 95% CI: −13.69, 7.67) and may increase adverse effects for sciatica (OR 3.27, 95% CI: 1.78, 6.00). Conclusion Anti-NGF may offer small reductions in pain intensity for chronic LBP. The effect may depend on the dose and types of medicines. For sciatica, anti-NGF or pro-GDNF may not reduce pain. Medicines that target neurotrophic factors for LBP or sciatica are associated with different adverse effects compared to those observed in commonly prescribed medicines for these conditions. [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]

Exercise leads to clinically meaningful pain reductions in people with chronic low back pain and is recommended as a first line treatment. The benefits of exercise for chronic low back pain decrease over time with a lack of long-term exercise adherence as a potential reason for this decreasing effect. We aimed to identify the barriers and enablers to exercise adherence from the perspective of people with chronic low back pain. This qualitative study was underpinned by a constructivist epistemology and used a critical realist ontological perspective. Adults (18-65 years) with chronic low back pain who had exercised since the onset of their back pain were recruited to participate in focus groups and individual interviews. Audio data were transcribed and then analysed in 2 stages 1) inductive coding using reflexive thematic analysis, followed by 2) deductive analysis through mapping codes onto the Theoretical Domains Framework. Five enablers and 3 barriers were identified across 6 of the 14 Theoretical Domain Framework domains. Exercise identity and confidence in deciding to self-manage pain were enablers, whereas beliefs about the consequences of exercise, exercise context, and relationships could function as either barriers or enablers. These barriers and enablers were complex and fluid, with participants reporting conflicting barriers and enablers that varied, depending on context. These findings improve our understanding of the barriers and enablers to exercise adherence from the individual perspective of people with chronic low back pain and can be utilised for more effective exercise treatment in this population. PERSPECTIVE: This article presents the barriers and enablers to exercise adherence from the perspective of people with chronic low back pain. These perspectives may aid to individualise and optimise exercise treatment, improve its long-term adherence and therefore its effectiveness for chronic low back pain., (Copyright © 2024 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

A new wave of treatments has emerged to target nervous system alterations and maladaptive conceptualizations about pain for chronic low back pain. The acceptability of these treatments is still uncertain. We conducted a qualitative study alongside a randomized controlled trial to identify perceptions of facilitators or barriers to participation in a non-pharmacological intervention that resulted in clinically meaningful reductions across 12 months for disability compared to a sham intervention. We conducted semi-structured interviews with participants from the trial's active arm after they completed the 12-week program. We included a purposeful sample (baseline and clinical characteristics) (n = 20). We used reflexive thematic analysis informed by the Theoretical Framework of Acceptability for health care interventions. We identified positive and negative emotional/cognitive responses associated with treatment acceptability and potential efficacy, including emotional support, cognitive empowerment, readiness for self-management, and acceptance of face-to-face and online components designed to target the brain. These findings suggest the importance of psychoeducation and behavior change techniques to create a positive attitude towards movement and increase the perception of pain control; systematic approaches to monitor and target misconceptions about the interventions during treatment; and psychoeducation and behavior change techniques to maintain the improvements after the cessation of formal care. PERSPECTIVE: This article presents the experiences of people with chronic low back pain participating in a new non-pharmacological brain-targeted treatment that includes face-to-face and self-directed approaches. The facilitators and barriers of the interventions could potentially inform adaptations and optimization of treatments designed to target the brain to treat chronic low back pain., (Copyright © 2023. Published by Elsevier Inc.)

Background: 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., Results: 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., Conclusion: This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial., Trial Registration: ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619)., (Copyright © 2020 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier España, S.L.U. All rights reserved.)

The potential benefits of combining pain education (PE) with clinical hypnosis (CH) has not yet been investigated in individuals with chronic pain. A total of 100 patients with chronic nonspecific low back pain were randomized to receive either: 1) PE alone, or 2) PE with CH. Outcomes were collected by a blinded assessor at 2 weeks and 3 months after randomization. The primary outcomes were average pain intensity, worst pain intensity (both assessed with 11-point numeric rating scales), and disability (24-item Roland Morris Disability Questionnaire) at 2 weeks. At 2 weeks, participants who received PE with CH reported lower worst pain intensity (mean difference = 1.35 points, 95% confidence interval [CI] = .32-2.37) and disability (mean difference = 2.34 points, 95% CI = .06-4.61), but not average pain intensity (mean difference = .67 point, 95% CI = -.27 to 1.62), relative to participants who received PE alone. PE with CH participants also reported more global perceived benefits at 2 weeks (mean difference = -1.98 points, 95% CI = -3.21 to -.75). At 3 months, participants who received PE with CH reported lower worst pain intensity (mean difference = 1.32 points, 95% CI = .29-2.34) and catastrophizing (mean difference = 5.30 points, 95% CI = 1.20-9.41). No adverse effects in either treatment condition were reported. To our knowledge, this is the first trial showing that additional use of hypnosis with PE results in improved outcomes over PE alone in patients with chronic nonspecific low back pain., Perspective: This study provides evidence supporting the efficacy of another treatment option for teaching patients to self-manage chronic low back pain that has a relatively low cost and that can be offered in groups., (Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.)