Exercise Therapy for Treatment of Acute Non-specific Low Back Pain: A Cochrane Systematic Review and Meta-analysis of Randomized Controlled Trials.

OBJECTIVE: To assess the effectiveness of exercise for acute non-specific low back pain (LBP) vs 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 randomized controlled trials on the effectiveness of exercise in adults with acute LBP (<6 weeks). Studies examining LBP with a specific etiology 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 randomized controlled trials (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 randomized controlled trials had a high risk of bias, were small in size, and/or there was substantial heterogeneity. CONCLUSION: Exercise therapy compared with 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.

Implementation of back to living well, a community-based program for the tertiary prevention of low back pain: a study protocol.

BACKGROUND: The current literature supports the effectiveness of exercise, education, and self-management interventions for the long-term management of persistent low back pain. However, there is significant uncertainty about the implementation of interventions related to barriers, facilitators, and patient's preferences. This study will evaluate the Back to Living Well program implementation from a participant and organizational perspective. More specifically we address the following objectives: 1) identify program barriers and facilitators from participants' perspectives, 2) identify factors related to program, personal and contextual factors that contribute to negative and positive outcomes, and outcome trajectories, 3) identify factors influencing participants' selection of an in-person or e-health program, and 4) evaluate program specific barriers and facilitators from the organization and care delivery perspectives. METHODS: This study will utilize a mixed-method convergent design including a longitudinal cohort strand and a longitudinal qualitative interview strand. The RE-AIM framework will be used to assess program implementation. Participants (n = 90, 1:1: in person or virtual) who choose to register in the program as well as staff (n = 10 to 15) involved in the delivery of the program will be invited to participate. Participants will participate in a 12-week physical activity, education, and self-management program. Implementation outcomes will be measured at 3-, 6-, 12-months, and six months after the end of the follow-ups. Interview scripts and directed content analysis will be constructed based on the Theoretical Domains Framework and the Neuromatrix Model of Pain, Theoretical Domains Framework. Staff interviews will be constructed and analyzed using the Consolidated Framework for Implementation Research. Participants will also complete pain, disability, quality of life and psychological questionnaires, wear an activity tracker at all time points, and complete weekly pain and activity limitation questions using a mobile application. DISCUSSION: The study results will provide evidence to inform potential future implementation of the program. An effective, appropriately targeted, and well implemented exercise program for the long-term management (i.e., tertiary prevention) of LBP could minimize the burden of the condition on patients, the health care system and society. TRIAL REGISTRATION: ClinicalTrials.gov NCT05929846. This (Registration Date: July 3 2023) study has been approved by the Hamilton Integrated Research Ethics Board Project ID#15,354.

Contexts, behavioural mechanisms and outcomes to optimise therapeutic exercise prescription for persistent low back pain: a realist review.

OBJECTIVE: Therapeutic exercises are a core treatment for low back pain (LBP), but it is uncertain how rehabilitative exercise facilitates change in outcomes. Realist reviews explore how the context (C) of certain settings or populations and underlying mechanisms (M) create intended or unintended outcomes (O). Our objective was to explore and understand the behavioural mechanisms by which therapeutic exercise creates change in outcomes of adherence, engagement and clinical outcomes for patients with LBP. METHODS: This was a realist review reported following the Realist and Meta-narrative Evidence Syntheses: Evolving Standards guidance. We developed initial programme theories, modified with input from a steering group (experts, n=5), stakeholder group (patients and clinicians, n=10) and a scoping search of the published literature (n=37). Subsequently, an information specialist designed and undertook an iterative search strategy, and we refined and tested CMO configurations. RESULTS: Of 522 initial papers identified, 75 papers were included to modify and test CMO configurations. We found that the patient-clinician therapeutic consultation builds a foundation of trust and was associated with improved adherence, engagement and clinical outcomes, and that individualised exercise prescription increases motivation to adhere to exercise and thus also impacts clinical outcomes. Provision of support such as timely follow-up and supervision can further facilitate motivation and confidence to improve adherence to therapeutic exercises for LBP. CONCLUSIONS: Engagement in and adherence to therapeutic exercises for LBP, as well as clinical outcomes, may be optimised using mechanisms of trust, motivation and confidence. These CMO configurations provide a deeper understanding of ways to optimise exercise prescription for patients with LBP.

An online training resource for clinicians to optimise exercise prescription for persistent low back pain: Design, development and usability testing.

BACKGROUND: Low back pain (LBP) is the leading cause of disability worldwide. A recent realist review identified the behavioural mechanisms of trust, motivation, and confidence as key to optimising exercise prescription for persistent LBP. OBJECTIVES: Our objectives were to (1) design and develop an online training programme, and (2) gain end-user feedback on the useability, usefulness, informativeness and confidence in using the online training programme using a mixed-methods, pre-post study design. PARTICIPANTS AND INTERVENTION: The online training programme was designed and developed using the results from a realist review, and input from a multi-disciplinary stakeholder group. A five-module online training programme was piloted by the first 10 respondents who provided feedback on the course. Further modifications were made prior to additional piloting. The satisfaction, usefulness, ease of use, and confidence of clinicians in applying the learned principles were assessed on completion. RESULTS: The online programme was advertised to clinicians using social media. Forty-four respondents expressed initial interest, of which 22 enrolled and 18 completed the course. Of the participants, most were physiotherapists (n = 16/18, 88.9%), aged between 30 and 49 (n = 11/18, 61.1%). All participants were satisfied with the course content, rated the course platform as easy to use and useful, and reported that they were very confident to apply the learning. Most (n = 10/14, 71.4%) reported that their manner of prescribing exercise had changed after completion of the course. CONCLUSIONS: An online training programme to optimise exercise prescription for persistent LBP appears to be easy to use, informative and improves confidence to apply the learning.

Sleep as a prognostic factor in low back pain: a systematic review of prospective cohort studies and secondary analyses of randomized controlled trials.

Sleep problems are common in individuals with low back pain (LBP) and sleep restriction seems to be associated with impaired pain processing. Our objective was to investigate whether sleep is associated with future LBP outcomes (i.e. pain intensity, disability, and recovery) in adults. We conducted a systematic review of prospective cohort studies and secondary analyses of randomized controlled trials (registration-PROSPERO CRD42022370781). In December 2022, we searched the MEDLINE, Embase, CINAHL, and PsycINFO databases. Fourteen studies, totaling 19 170 participants were included. Thirteen studies were rated as having high risk of bias (QUIPS tool). We used vote-counting and meta-analysis approaches to synthesize the data. We found associations between baseline sleep with future pain intensity, recovery, and between changes in sleep with changes in pain intensity, changes in disability, and recovery. We further synthesized outcomes as "overall LBP improvement" outcomes. Baseline poor sleep was moderately associated with non-improvement in LBP in the long-very long term (OR 1.55, 95% CI: 1.39 to 1.73; three studies providing unadjusted effect sizes), and non-improvement in sleep was largely associated with non-improvement in LBP in the short-moderate term (OR 3.45, 95% CI: 2.54 to 4.69; four studies providing unadjusted effect sizes). We found no association between baseline sleep with future disability and overall LBP improvement in the short-moderate term. Therefore, sleep may be a prognostic factor for pain intensity and recovery from LBP. All findings were supported by low to very low-quality evidence. Better-conducted studies are needed to strengthen our certainty about the evidence.

Understanding how therapeutic exercise prescription changes outcomes important to patients with persistent non-specific low back pain: a realist review protocol.

INTRODUCTION: Persistent low back pain (LBP) is the leading cause of disability worldwide, and therapeutic exercise is recommended as a first-line treatment in international guidelines. The effects of exercise on clinical outcomes of pain and physical function are small to moderate, despite broader impacts on cardiovascular systems, biological health, mood, and emotional well-being. Therapeutic exercise prescription is defined as exercise that is prescribed by a clinician for a health-related treatment. It is unknown how therapeutic exercise prescription creates effects on outcomes of importance. Realist reviews explore how underlying mechanisms (M) may be active in the context (C) of certain situations, settings, or populations to create an intended or unintended outcome (O). Our objective is to explore and understand the mechanisms by which therapeutic exercise prescription changes outcomes for people with persistent LBP. METHODS: We will develop initial programme theories based on preliminary data from a previous systematic review and consensus workshop. These theories will be modified with input from a steering group (experts), a stakeholder group (people with lived experience of exercise for persistent LBP and clinicians), and a scoping search of the published literature. An information specialist will design and undertake an iterative search strategy. These will be used to create CMO configurations, which will be refined and tested using the literature. The realist review will be reported following RAMESES guidance. DISCUSSION: Realist reviews are uncommon in LBP research to date, yet those offer an opportunity to contrast with traditional methods of randomised controlled trials and systematic reviews and provide additional information regarding the contexts and mechanisms that may trigger certain outcomes. This can aid our understanding of the contextual features that may influence exercise prescription, such as for whom they are most effective, in what setting, how they are implemented and why. This realist synthesis will enhance our understanding of therapeutic exercise prescription to improve adherence and engagement and ultimately will provide clinically relevant recommendations regarding exercise prescription for those with persistent LBP. SYSTEMATIC REVIEW REGISTRATION: The review has been registered with PROSPERO (CRD42017072023).

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. ETHICS AND DISSEMINATION: The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

A survey of experts to identify methods to detect problematic studies: Stage 1 of the INSPECT-SR Project.

Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INSPECT-SR project is developing a tool to identify problematic RCTs in systematic reviews of healthcare-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion. Methods: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorised these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list. Results: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool. Conclusions: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool.