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).

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.

The Frequency of Symptoms in Patients With a Diagnosis of Degenerative Cervical Myelopathy: Results of a Scoping Review.

STUDY DESIGN: Delayed diagnosis of degenerative cervical myelopathy (DCM) is associated with reduced quality of life and greater disability. Developing diagnostic criteria for DCM has been identified as a top research priority. OBJECTIVES: This scoping review aims to address the following questions: What is the diagnostic accuracy and frequency of clinical symptoms in patients with DCM? METHODS: A scoping review was conducted using a database of all primary DCM studies published between 2005 and 2020. Studies were included if they (i) assessed the diagnostic accuracy of a symptom using an appropriate control group or (ii) reported the frequency of a symptom in a cohort of DCM patients. RESULTS: This review identified three studies that discussed the diagnostic accuracy of various symptoms and included a control group. An additional 58 reported on the frequency of symptoms in a cohort of patients with DCM. The most frequent and sensitive symptoms in DCM include unspecified paresthesias (86%), hand numbness (82%) and hand paresthesias (79%). Neck and/or shoulder pain was present in 51% of patients with DCM, whereas a minority had back (19%) or lower extremity pain (10%). Bladder dysfunction was uncommon (38%) although more frequent than bowel (23%) and sexual impairment (4%). Gait impairment is also commonly seen in patients with DCM (72%). CONCLUSION: Patients with DCM present with many different symptoms, most commonly sensorimotor impairment of the upper extremities, pain, bladder dysfunction and gait disturbance. If patients present with a combination of these symptoms, further neuroimaging is indicated to confirm the diagnosis of DCM.

The value of Clinical signs in the diagnosis of Degenerative Cervical Myelopathy - A Systematic review and Meta-analysis.

STUDY DESIGN: Delayed diagnosis of degenerative cervical myelopathy (DCM) is likely due to a combination of its subtle symptoms, incomplete neurological assessments by clinicians and a lack of public and professional awareness. Diagnostic criteria for DCM will likely facilitate earlier referral for definitive management. OBJECTIVES: This systematic review aims to determine (i) the diagnostic accuracy of various clinical signs and (ii) the association between clinical signs and disease severity in DCM? METHODS: A search was performed to identify studies on adult patients that evaluated the diagnostic accuracy of a clinical sign used for diagnosing DCM. Studies were also included if they assessed the association between the presence of a clinical sign and disease severity. The QUADAS-2 tool was used to evaluate the risk of bias of individual studies. RESULTS: This review identified eleven studies that used a control group to evaluate the diagnostic accuracy of various signs. An additional 61 articles reported on the frequency of clinical signs in a cohort of DCM patients. The most sensitive clinical tests for diagnosing DCM were the Tromner and hyperreflexia, whereas the most specific tests were the Babinski, Tromner, clonus and inverted supinator sign. Five studies evaluated the association between the presence of various clinical signs and disease severity. There was no definite association between Hoffmann sign, Babinski sign or hyperreflexia and disease severity. CONCLUSION: The presence of clinical signs suggesting spinal cord compression should encourage health care professionals to pursue further investigation, such as neuroimaging to either confirm or refute a diagnosis of DCM.

Toward Shared Decision-Making in Degenerative Cervical Myelopathy: Protocol for a Mixed Methods Study.

BACKGROUND: Health care decisions are a critical determinant in the evolution of chronic illness. In shared decision-making (SDM), patients and clinicians work collaboratively to reach evidence-based health decisions that align with individual circumstances, values, and preferences. This personalized approach to clinical care likely has substantial benefits in the oversight of degenerative cervical myelopathy (DCM), a type of nontraumatic spinal cord injury. Its chronicity, heterogeneous clinical presentation, complex management, and variable disease course engenders an imperative for a patient-centric approach that accounts for each patient's unique needs and priorities. Inadequate patient knowledge about the condition and an incomplete understanding of the critical decision points that arise during the course of care currently hinder the fruitful participation of health care providers and patients in SDM. This study protocol presents the rationale for deploying SDM for DCM and delineates the groundwork required to achieve this. OBJECTIVE: The study's primary outcome is the development of a comprehensive checklist to be implemented upon diagnosis that provides patients with essential information necessary to support their informed decision-making. This is known as a core information set (CIS). The secondary outcome is the creation of a detailed process map that provides a diagrammatic representation of the global care workflows and cognitive processes involved in DCM care. Characterizing the critical decision points along a patient's journey will allow for an effective exploration of SDM tools for routine clinical practice to enhance patient-centered care and improve clinical outcomes. METHODS: Both CISs and process maps are coproduced iteratively through a collaborative process involving the input and consensus of key stakeholders. This will be facilitated by Myelopathy.org, a global DCM charity, through its Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy community. To develop the CIS, a 3-round, web-based Delphi process will be used, starting with a baseline list of information items derived from a recent scoping review of educational materials in DCM, patient interviews, and a qualitative survey of professionals. A priori criteria for achieving consensus are specified. The process map will be developed iteratively using semistructured interviews with patients and professionals and validated by key stakeholders. RESULTS: Recruitment for the Delphi consensus study began in April 2023. The pilot-testing of process map interview participants started simultaneously, with the formulation of an initial baseline map underway. CONCLUSIONS: This protocol marks the first attempt to provide a starting point for investigating SDM in DCM. The primary work centers on developing an educational tool for use in diagnosis to enable enhanced onward decision-making. The wider objective is to aid stakeholders in developing SDM tools by identifying critical decision junctures in DCM care. Through these approaches, we aim to provide an exhaustive launchpad for formulating SDM tools in the wider DCM community. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46809.

Pain catastrophising and kinesiophobia mediate pain and physical function improvements with Pilates exercise in chronic low back pain: a mediation analysis of a randomised controlled trial.

QUESTION: How much are the reductions in pain intensity and improvements in physical function from Pilates exercise mediated by changes in pain catastrophising and kinesiophobia? DESIGN: This was a secondary causal mediation analysis of a four-arm randomised controlled trial testing Pilates exercise dosage (once, twice or thrice per week) against a booklet control. PARTICIPANTS: Two hundred and fifty-five people with chronic low back pain. DATA ANALYSIS: All analyses were conducted in R software (version 4.1.2) following a preregistered analysis plan. A directed acyclic graph was constructed to identify potential pre-treatment mediator-outcome confounders. For each mediator model, we estimated the intervention-mediator effect, the mediator-outcome effect, the total natural indirect effect (TNIE), the pure natural direct effect (PNDE), and the total effect (TE). RESULTS: Pain catastrophising mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.21, 95% CI -0.47 to -0.03) and physical function (TNIE MD -0.64, 95% CI -1.20 to -0.18). Kinesiophobia mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.31, 95% CI -0.68 to -0.02) and physical function (TNIE MD -1.06, 95% CI -1.70 to -0.49). The proportion mediated by each mediator was moderate (21 to 55%). CONCLUSION: Reductions in pain catastrophising and kinesiophobia partially mediated the pathway to improved pain intensity and physical function when using Pilates exercise for chronic low back pain. These psychological components may be important treatment targets for clinicians and researchers to consider when prescribing exercise for chronic low back pain.

Matching the Outcomes to Treatment Targets of Exercise for Low Back Pain: Does it Make a Difference? Results of Secondary Analyses From Individual Patient Data of Randomised Controlled Trials and Pooling of Results Across Trials in Comparative Meta-analysis.

OBJECTIVE: To explore whether using a single matched or composite outcome might affect the results of previous randomized controlled trials (RCTs) testing exercise for non-specific low back pain (NSLBP). The first objective was to explore whether a single matched outcome generated greater standardized mean differences (SMDs) when compared with the original unmatched primary outcome SMD. The second objective was to explore whether a composite measure, composed of matched outcomes, generated a greater SMD when compared with the original primary outcome SMD. DESIGN: We conducted exploratory secondary analyses of data. SETTING: Seven RCTs were included, of which 2 were based in the USA (University research clinic, Veterans Affairs medical center) and the UK (primary care clinics, nonmedical centers). One each were based in Norway (clinics), Brazil (primary care), and Japan (outpatient clinics). PARTICIPANTS: The first analysis comprised 1) 5 RCTs (n=1033) that used an unmatched primary outcome but included (some) matched outcomes as secondary outcomes, and the second analysis comprised 2) 4 RCTs (n=864) that included multiple matched outcomes by developing composite outcomes (N=1897). INTERVENTION: Exercise compared with no exercise. MAIN OUTCOME MEASURES: The composite consisted of standardized averaged matched outcomes. All analyses replicated the RCTs' primary outcome analyses. RESULTS: Of 5 RCTs, 3 had greater SMDs with matched outcomes (pooled effect SMD 0.30 [95% confidence interval {CI} 0.04, 0.56], P=.02) compared with an unmatched primary outcome (pooled effect SMD 0.19 [95% CI -0.03, 0.40] P=.09). Of 4 composite outcome analyses, 3 RCTs had greater SMDs in the composite outcome (pooled effect SMD 0.28 [95% CI 0.05, 0.51] P=.02) compared with the primary outcome (pooled effect SMD 0.24 [95% CI -0.04, 0.53] P=.10). CONCLUSIONS: These exploratory analyses suggest that using an outcome matched to exercise treatment targets in NSLBP RCTs may produce greater SMDs than an unmatched primary outcome. Composite outcomes could offer a meaningful way of investigating superiority of exercise than single domain outcomes.

Was the impact of COVID-19 on a spinal triage service as significant as expected? A retrospective service evaluation: Results and evaluation.

OBJECTIVES: The aim of this evaluation was to review service outcomes for a spinal advanced practitioner physiotherapy (APP) triage service during COVID-19. The evaluation compares outcomes gathered against pre-pandemic data and evaluates the impact of the pandemic on service delivery. DESIGN: Service-level data were extracted between 2019 and 2021 including: total referrals, new and follow-up appointments, telehealth consultation rates, discharges at first appointment, magnetic resonance imaging and injection request rates. Multidisciplinary-team (MDT) meeting notes with Spinal Surgeons were reviewed and surgical conversion calculated. Patient satisfaction data were collated using: Friends and Family test, specific questionnaires, individual and formal complaints and compliments, and telephone surveys. Analysis was performed by the lead author and results were compared between years using analysis of variance, as well as with previously reported data. SETTING: 'Nottingham University Hospitals' National Health Services Trust is a secondary care spinal unit, using APPs to triage, assess and manage spinal conditions. RESULTS: In 2020, 407 (22%; p = 0.02) less patients were referred to the service, however, there was a significant increase in the number of telehealth attendances (mean = 50% in 2020 from 2019, p = 0.005). Only 13% (n = 1342) patients were discussed at MDT, of which 8% (n = 808) were discussed for surgical consideration, and 36% (n = 268) were directly listed. High levels of patient satisfaction were reported by 89% (n = 1028 of 1160) patients. CONCLUSION: This service evaluation demonstrates a statistically significant change in numbers of patients referred and telehealth attendances in the year of the pandemic (2020). Surgical conversion declined during the pandemic, and did not recover post-pandemic.

Patient satisfaction with the first contact physiotherapy service: Results from the national evaluation survey.

BACKGROUND: Musculoskeletal (MSK) First Contact Physiotherapists (FCPs) are diagnostic clinicians able to assess and manage undifferentiated and undiagnosed MSK presentations. The FCP role in primary care has been introduced to allow patients with MSK pain to see a FCP directly rather than wait to see a General Practitioner (GP) first, which improves capacity within primary care. A national evaluation was undertaken of the FCP model. This article reports the thematic analysis of the free-text responses of patients who participated in the national evaluation. METHODS: An online platform collected patient-reported experience and outcomes following the FCP consultation and at 1, 2 and 3 months follow-up. Free-text responses to the Friends and Family test, reasons for consulting another health care professional (HCP) and general comments were thematically analysed and grouped according to their responses. RESULTS: Over 13 months, 680 of 2825 registered patients (24%) completed the initial questionnaire and 54% (n = 370) completed the 3-month follow-up. During the course of the evaluation, 785 participants provided free-text responses. Themes identified from free-text responses were: communication and knowledge, clinicians' characteristics, efficiency, treatment provided, assessment skills and service provided in comparison to GP care. Complaints represented 4% (n = 26 comments) of total feedback. The main reasons for consulting other HCPs after seeing a FCP were persistent pain, delays in referrals or already attending NHS physiotherapy. CONCLUSION: Thematic analysis of free-text responses in the national FCP evaluation provides context and detail to the positive outcomes reported by patients after consulting a FCP in primary care.

Treatment targets of exercise for persistent non-specific low back pain: a consensus study.

OBJECTIVES: Despite several hundred previous randomised controlled trials (RCTs), the key treatment targets of exercise for persistent non-specific low back pain (NSLBP) remain unclear. This study aimed to generate consensus about the key treatment targets of exercise interventions for patients with NSLBP. DESIGN: Consensus was generated using modified nominal group technique in two, sequential, workshops. The results of a previous systematic review informed the first, national, workshop idea generation and the results of this workshop informed the second, international, workshop. The authors generated a starting list of 30 treatment targets from the systematic review. A pre-specified consensus threshold of 75% was used in the voting stage. PARTICIPANTS: Workshop participants included people with experience of using exercise to manage their persistent NSLBP, clinicians who prescribe exercise for persistent NSLBP, and researchers who design and evaluate exercise interventions in RCTs. All participants generated, voted and ranked the treatment targets in each workshop using an online platform. RESULTS: A total of 39 participants contributed to the consensus (15 in the national workshop and 24 in the international workshop), comprising two people with NSLBP, six clinicians and 31 researchers/clinicians. A total of 40 exercise treatment targets were generated, and 25 were retained after voting and ranking. The prioritised targets of exercise for persistent NSLBP were: improving function, improving quality of life, reducing pain, meeting patient-specific goals and reducing fear of movement. CONCLUSIONS: Future RCTs of exercise should specify the targets of their exercise intervention and consider assessing these treatment targets as well as including mediation analyses.

Exercise Interventions for Persistent Non-Specific Low Back Pain - Does Matching Outcomes to Treatment Targets Make a Difference? A Systematic Review and Meta-Analysis.

Exercise is a core treatment for persistent non-specific low back pain (NSLBP), but results from randomised controlled trials (RCTs) of exercise typically show only small to moderate standardised mean differences (SMDs) compared to nonexercise controls. The choice of primary outcome, and relationship to the specific targets of exercise may influence this. This systematic review aimed to explore whether primary outcomes match the exercise treatment targets used in NSLBP RCTs and the potential impact of matching on SMDs. Included RCTs were conducted with patients with persistent NSLBP, compared exercise to no exercise, with sample sizes >60 per arm. Screening, data extraction and risk of bias assessment were independently undertaken by paired reviewers. Of 19272 initial titles, 27 RCTs were included with 31 treatment targets and 6 primary outcome domains identified. Only 25% of included RCTs had primary outcomes that matched the treatment targets. SMDs of exercise versus comparison arms were observed to be larger in the matched (SMD .54 (95% Confidence Interval .23 to.85), P =.0006) compared to the unmatched category (SMD 0.22 (95% Confidence Interval .01, .44) P = .04) but this difference was not statistically significant (P = .10). These exploratory findings may have implications for future teams developing RCTs of exercise for NSLBP and warrant further investigation in larger datasets. PERSPECTIVE: This review was an exploratory study that investigated the primary outcome and treatment targets used in RCTs of exercise for NSLBP. The SMDs of the matched group were descriptively larger than those of the unmatched group, but further analysis with larger sample sizes is required to have confidence in these results.

A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability.

BACKGROUND AND OBJECTIVE: Pain neuroscience education (PNE) has shown promising ability in previous reviews to improve pain and disability in chronic low back pain (CLBP). This review aimed to evaluate randomized controlled trials comparing the effectiveness of PNE on pain and disability in CLBP. DATABASES AND DATA TREATMENT: A systematic search was performed using the databases of EBSCO, Medline, Cochrane and Web of Science. Meta-analysis was performed using the RevMan 5.1 software to pool outcomes using the random effects model, weighted mean differences (WMD), standard deviation, 95% confidence intervals and sample size. GRADEpro software was utilized to calculate overall strength of evidence. RESULTS: A total of 6,767 papers were found, eight were included (n = 615). Meta-analysis for short-term pain (n = 428) demonstrated a WMD of 0.73 (95%CI -0.14, 1.61) on a ten-point scale of PNE against no PNE (GRADE analysis low evidence). When PNE alongside physiotherapy interventions were grouped for pain (n = 212), a WMD of 1.32 was demonstrated (95% CI 1.08, 1.56, p < 0.00001; GRADE analysis moderate evidence). Short-term disability (RMDQ) meta-analysis demonstrated a WMD of 0.42 (95%CI 0.28, 0.56; p < 0.00001; n = 362; GRADE analysis moderate evidence); whereas the addition of PNE to physiotherapy interventions demonstrated a WMD of 3.94 (95% CI 3.37, 4.52; p < 0.00001; GRADE analysis moderate evidence. CONCLUSION: This review presents moderate evidence that the addition of PNE to usual physiotherapy intervention in patients with CLBP improves disability in the short term. However, this meta-analysis failed to show evidence of long-term improvement on pain or disability when adding PNE to usual physiotherapy. SIGNIFICANCE: This review demonstrates moderate level evidence that the use of pain neuroscience education alongside physiotherapy interventions probably improves disability and pain in the short term in chronic low back pain. These results provide greater support for the addition of pain neuroscience education in routine physiotherapy practice in chronic low back pain.