Similar improvements in patient-reported outcomes for non-specific low back pain patients with and without lumbar spinal stenosis symptoms following a structured education and exercise therapy program.

BACKGROUND: People with nonspecific low back pain (NSLBP) can also experience overlapping symptoms of lumbar spinal stenosis (LSS), but the impact on treatment outcomes is unknown. This study investigated differences in treatment outcomes for disability, back pain intensity, and leg pain intensity following an education and exercise therapy program for NSLBP patients with and without comorbid LSS symptoms. METHODS: This was a longitudinal analysis of 655 Danish participants in the GLA:D® Back program; an education and exercise therapy program for people with persistent NSLBP. Participants were classified as having comorbid LSS symptoms based on self-report. Linear mixed models were used to assess differences in change in disability (Oswestry Disability Index [0-100]) and back and leg pain intensity (Numeric Rating Scale [0-10]) at 3-, 6-, and 12-months between those with and without LSS symptoms. RESULTS: 28% of participants reported LSS symptoms. No certain differences in change in disability or back pain intensity improvement were observed at any time-point between those with and without LSS symptoms. Participants with LSS symptoms had slightly greater improvement in leg pain intensity at 6- (-0.7, 95% CI -1.2 to -0.2) and 12-months (-0.6, 95% CI -1.2 to -0.1). CONCLUSION: Compared to those without LSS symptoms, patients with persistent NSLBP and LSS symptoms can expect similar improvements in disability and back pain intensity, and slightly greater improvements in leg pain intensity with treatment. Therefore, education and exercise therapy programs designed for NSLBP are likely helpful for those also experiencing LSS symptoms.

The GLA:D BACK self-management adherence and competence checklist (SMAC Checklist)-Development, content validity and feasibility.

OBJECTIVES: To unpack the complexity and impact of self-management interventions targeting musculoskeletal health conditions, we need to learn more about treatment delivery in clinical settings. Fidelity evaluation can illuminate how complex treatments are delivered and help understand the elements that lead to the effect. The objective of this study was to develop a checklist for the evaluation of the clinicians' delivery of structured patient education and exercise intervention for people with persistent back pain, the GLA:D Back intervention. The intent was to provide a checklist adaptable for the general delivery of self-management interventions for musculoskeletal pain. METHODS: We derived items for the treatment delivery fidelity checklist from behaviour change techniques and theory about communication style. We applied a three-step developmental process covering developing a preliminary fidelity intervention framework, validating checklist content and piloting and refining the checklist. RESULTS: We developed the adaptable fidelity checklist, The GLA:D BACK Self-management Adherence and Competence Checklist (SMAC Checklist). Evaluation of clinical practice using the checklist was feasible and acceptable by clinicians. Preliminary results indicate satisfactory observer agreement during pilot testing of the checklist. CONCLUSION: The GLA:D BACK Self-management Adherence and Competence Checklist is a fidelity measurement tool for the assessment of the delivery of a self-management supportive intervention for people with persistent back pain. The intention is that it can be useful as an adaptable tool for use across self-management interventions for musculoskeletal pain.

Self-management at the core of back pain care: 10 key points for clinicians.

BACKGROUND: A paradigm shift away from clinician-led management of people with chronic disorders to people playing a key role in their own care has been advocated. At the same time, good health is recognised as the ability to adapt to changing life circumstances and to self-manage. Under this paradigm, successful management of persistent back pain is not mainly about clinicians diagnosing and curing patients, but rather about a partnership where clinicians help individuals live good lives despite back pain. OBJECTIVE: In this paper, we discuss why there is a need for clinicians to engage in supporting self-management for people with persistent back pain and which actions clinicians can take to integrate self-management support in their care for people with back pain. DISCUSSION: People with low back pain (LBP) self-manage their pain most of the time. Therefore, clinicians and health systems should empower them to do it well and provide knowledge and skills to make good decisions related to LBP and general health. Self-management does not mean that people are alone and without health care, rather it empowers people to know when to consult for diagnostic assessment, symptom relief, or advice. A shift in health care paradigm and clinicians' roles is not only challenging for individual clinicians, it requires organisational support in clinical settings and health systems. Currently, there is no clear evidence showing how exactly LBP self-management is most effectively supported in clinical practice, but core elements have been identified that involve working with cognitions related to pain, behaviour change, and patient autonomy.

GLA:D® Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study.

BACKGROUND: Reassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a hybrid implementation-effectiveness design. The strategy and the evaluation were planned using the framework of the Behaviour Change Wheel. METHODS: The main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management. This comes with ready-to-use patient education materials and exercise programs. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The clinical intervention and potential effect mechanisms will be evaluated at the patient-level using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. The education of clinicians will be evaluated via clinician-level outcomes, including the Pain Attitudes and Beliefs Scale, the Practitioner Confidence Scale, and the Determinants of Implementation Behaviour Questionnaire. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave. DISCUSSION: This implementation-effectiveness study is designed to evaluate the process of implementing an evidence-based intervention for back pain. It will inform the development of strategies for implementing evidence-based care for musculoskeletal pain conditions, it will enhance the understanding of mechanisms for developing patient self-management skills, and it will demonstrate the outcomes that are achievable in everyday clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03570463 . Registered 27 June 2018.

GLA:D® Back group-based patient education integrated with exercises to support self-management of back pain - development, theories and scientific evidence.

BACKGROUND: Clinical guidelines recommend that people with back pain be given information and education about their back pain, advice to remain active and at work, and exercises to improve mobility and physical activity. Guidelines, however, rarely describe how this is best delivered. The aim of this paper is to present the development, theories, and underlying evidence for 'GLA:D Back' - a group education and exercise program that translates guideline recommendations into a clinician-delivered program for the promotion of self-management in people with persistent/recurrent back pain. METHODS: GLA:D Back, which included a rationale and objectives for the program, theory and evidence for the interventions, and program materials, was developed using an iterative process. The content of patient education and exercise programs tested in randomised trials was extracted and a multidisciplinary team of expert researchers and clinicians prioritised common elements hypothesised to improve back pain beliefs and management skills. The program was tested on eight people with persistent back pain in a university clinic and 152 patients from nine primary care physiotherapy and chiropractic clinics. Following feedback from the clinicians and patients involved, the working version of the program was created. RESULTS: Educational components included pain mechanisms, pain modulation, active coping strategies, imaging, physical activity, and exercise that emphasised a balance between the sum of demands and the individual's capacity. These were operationalised in PowerPoint presentations with supporting text to aid clinicians in delivering two one-hour patient education lectures. The exercise program included 16 supervised one-hour sessions over 8 weeks, each comprising a warm-up section and eight types of exercises for general flexibility and strengthening of six different muscle groups at four levels of difficulty. The aims of the exercises were to improve overall back fitness and, at the same time, encourage patients to explore variations in movement by incorporating education content into the exercise sessions. CONCLUSION: From current best evidence about prognostic factors in back pain and effective treatments for back pain, research and clinical experts developed a ready-to-use structured program - GLA:D® Back - to support self-management for people with persistent/recurrent back pain.

What low back pain is and why we need to pay attention.

Low back pain is a very common symptom. It occurs in high-income, middle-income, and low-income countries and all age groups from children to the elderly population. Globally, years lived with disability caused by low back pain increased by 54% between 1990 and 2015, mainly because of population increase and ageing, with the biggest increase seen in low-income and middle-income countries. Low back pain is now the leading cause of disability worldwide. For nearly all people with low back pain, it is not possible to identify a specific nociceptive cause. Only a small proportion of people have a well understood pathological cause-eg, a vertebral fracture, malignancy, or infection. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greatest risk of reporting low back pain. Disabling low back pain is over-represented among people with low socioeconomic status. Most people with new episodes of low back pain recover quickly; however, recurrence is common and in a small proportion of people, low back pain becomes persistent and disabling. Initial high pain intensity, psychological distress, and accompanying pain at multiple body sites increases the risk of persistent disabling low back pain. Increasing evidence shows that central pain-modulating mechanisms and pain cognitions have important roles in the development of persistent disabling low back pain. Cost, health-care use, and disability from low back pain vary substantially between countries and are influenced by local culture and social systems, as well as by beliefs about cause and effect. Disability and costs attributed to low back pain are projected to increase in coming decades, in particular in low-income and middle-income countries, where health and other systems are often fragile and not equipped to cope with this growing burden. Intensified research efforts and global initiatives are clearly needed to address the burden of low back pain as a public health problem.

SpineData - a Danish clinical registry of people with chronic back pain.

BACKGROUND: Large-scale clinical registries are increasingly recognized as important resources for quality assurance and research to inform clinical decision-making and health policy. We established a clinical registry (SpineData) in a conservative care setting where more than 10,000 new cases of spinal pain are assessed each year. This paper describes the SpineData registry, summarizes the characteristics of its clinical population and data, and signals the availability of these data as a resource for collaborative research projects. METHODS: The SpineData registry is an Internet-based system that captures patient data electronically at the point of clinical contact. The setting is the government-funded Medical Department of the Spine Centre of Southern Denmark, Hospital Lillebaelt, where patients receive a multidisciplinary assessment of their chronic spinal pain. RESULTS: Started in 2011, the database by early 2015 contained information on more than 36,300 baseline episodes of patient care, plus the available 6-month and 12-month follow-up data for these episodes. The baseline questionnaire completion rate has been 93%; 79% of people were presenting with low back pain as their main complaint, 6% with mid-back pain, and 15% with neck pain. Collectively, across the body regions and measurement time points, there are approximately 1,980 patient-related variables in the database across a broad range of biopsychosocial factors. To date, 36 research projects have used data from the SpineData registry, including collaborations with researchers from Denmark, Australia, the United Kingdom, and Brazil. CONCLUSION: We described the aims, development, structure, and content of the SpineData registry, and what is known about any attrition bias and cluster effects in the data. For epidemiology research, these data can be linked, at an individual patient level, to the Danish population-based registries and the national spinal surgery registry. SpineData also has potential for the conduct of cohort multiple randomized controlled trials. Collaborations with other researchers are welcome.

The predictive and external validity of the STarT Back Tool in Danish primary care.

PURPOSE: The STarT Back Tool (SBT) was recently translated into Danish and its concurrent validity described. This study tested the predictive validity of the Danish SBT. METHODS: Danish primary care patients (n = 344) were compared to a UK cohort. SBT subgroup validity for predicting high activity limitation at 3 months' follow-up was assessed using descriptive proportions, relative risks, AUC and odds ratios. RESULTS: The SBT had a statistically similar predictive ability in Danish primary care as in UK primary care. Unadjusted relative risks for poor clinical outcome on activity limitation in the Danish cohort were 2.4 (1.7-3.4) for the medium-risk subgroup and 2.8 (1.8-3.8) for the high-risk subgroup versus 3.1 (2.5-3.9) and 4.5 (3.6-5.6) for the UK cohort. Adjusting for confounders appeared to explain the lower predictive ability of the Danish high-risk group. CONCLUSIONS: The Danish SBT distinguished between low- and medium-risk subgroups with a similar predictive ability of the UK SBT. That distinction is useful information for informing patients about their expected prognosis and may help guiding clinicians' choice of treatment. However, cross-cultural differences in the SBT psychosocial subscale may reduce the predictive ability of the high-risk subgroup in Danish primary care.

Deep muscle pain, tender points and recovery in acute whiplash patients: a 1-year follow-up study.

Local sensitization to noxious stimuli has been previously described in acute whiplash injury and has been suggested to be a risk factor for chronic sequelae following acute whiplash injury. In this study, we prospectively examined the development of tender points and mechano-sensitivity in 157 acute whiplash injured patients, who fulfilled criteria for WAD grade 2 (n=153) or grade 3 (n=4) seen about 5 days after injury (4.8+/-2.3) and who subsequently had or had not recovered 1 year after a cervical sprain. Tender point scores and stimulus-response function for mechanical pressure were determined in injured and non-injured body regions at specific time-points after injury. Thirty-six of 157 WAD grade 2 patients (22.9%) had not recovered, defined as reduced work capacity after 1 year. Non-recovered patients had higher total tender point scores after 12 (p<0.05), 107 (p<0.05) and 384 days (p<0.05) relative to those who recovered. Tenderness was found in the neck region and in remote areas in non-recovered patients. The stimulus-response curves for recovered and non-recovered patients were similar after 12 days and 107 days after the injury, but non-recovered patients had steeper stimulus-response curves for the masseter (p<0.02) and trapezius muscles (p<0.04) after 384 days. This study shows early mechano-sensitization after an acute whiplash injury and the development of further sensitization in patients with long-term disability.