The mental health-related barriers and benefits to exercise in adults with and without chronic pain.

Background: Qualitative evidence points to the importance of both mental health-related barriers and benefits to exercise in chronic pain, yet this bidirectional relationship has not been established quantitatively. Methods: 89 adults with chronic pain (75 female, Age: M = 34.7, SD=13.2), and 89 demographically-matched individuals without chronic pain (73 female, Age: M = 32.0, SD=13.3) self-reported demographic and health information, mental health-related barriers and benefits to exercise, and leisure-time exercise activity. Results: Adults with chronic pain had significantly higher scores on mental health-related barriers to exercise, and lower leisure-time exercise participation than adults without chronic pain. The groups did not differ on mental health-related benefits of exercise scores. Benefits scores positively predicted exercise, yet there was a significant negative interaction between pain and benefit scores, indicating a weaker positive relationship between benefits and exercise for adults with chronic pain than for those without chronic pain. Barrier scores significantly negatively predicted exercise engagement, but did not interact significantly with chronic pain. Conclusion: Mental health-related barriers and benefits to exercise are important considerations when prescribing exercise for adults with chronic pain. Adults with chronic pain may require individualised support to address mental health-related barriers to leisure-time exercise.

Evaluating the Use of PROMs in Paediatric Orthopaedic Registries.

Patient-reported outcome measures (PROMs) provide structured information on the patient's health experience and facilitate shared clinical decision-making. Registries that collect PROMs generate essential information about the clinical course and efficacy of interventions. Whilst PROMs are increasingly being used in adult orthopaedic registries, their use in paediatric orthopaedic registries is not well known. The purpose of this systematic review was to identify the frequency and scope of registries that collect PROMs in paediatric orthopaedic patient groups. In July 2023, six databases were systematically searched to identify studies that collected PROMs using a registry amongst patients aged under 18 years with orthopaedic diagnoses. Of 3190 identified articles, 128 unique registries were identified. Three were exclusively paediatric, 27 were majority paediatric, and the remainder included a minority of paediatric patients. One hundred and twenty-eight registries collected 72 different PROMs, and 58% of these PROMs were not validated for a paediatric population. The largest group of orthopaedic registries collected PROMs on knee ligament injuries (21%). There are few reported dedicated orthopaedic registries collecting PROMs in paediatric populations. The majority of PROMs collected amongst paediatric populations by orthopaedic registries are not validated for patients under the age of 18 years. The use of non-validated PROMs by registries greatly impedes their utility and impact. Dedicated orthopaedic registries collecting paediatric-validated PROMs are needed to increase health knowledge, improve decision-making between patients and healthcare providers, and optimise orthopaedic management.

Developing resilient clinical trials: Lessons learned from rolling out the Get Back to Healthy trial during a pandemic.

BACKGROUND: The COVID-19 pandemic has caused wide-spread disruptions to the conduct of randomised controlled trials (RCTs), particularly those involving public health services. Using the Get Back to Healthy trial as an example, this study aimed to contextualise the challenges imposed by the COVID-19 pandemic on implementation of RCTs involving public health services in Australia, summarise the effect of common and novel contingency strategies employed to mitigate these challenges, and describe key lessons learned. METHODS: The main challenges, the effect of contingency strategies employed, and key lessons learned were summarised descriptively. RESULTS: The main COVID-19-related challenge has been slow recruitment due to the suspension of clinical services for the trial target population. This challenge has been addressed through carefully considered adjustments to trial design (i.e., expanding the trial eligibility criteria), which has markedly improved trial recruitment rates. Other challenges have included the rapid transition to remote consent and data collection methods, increased complexity of monitoring participant safety, and future statistical challenges with disentangling the impact of the COVID-19 pandemic from treatment effects. The key lessons learned are: (i) adaptations to trial design may be necessary during a pandemic; (ii) offering remote methods may encourage trial participation from all age groups during a pandemic; (iii) enhanced monitoring of safety is critical during a pandemic; (iv) statistical challenges are likely to occur and should be considered when interpreting trial results. CONCLUSION: Key lessons learned may be useful for informing the conduct of resilient RCTs, particularly those involving public health services, in the present and future.

Implementation Initiatives to Improve Low Back Pain Care in Australia: A Scoping Review.

OBJECTIVE: This scoping review aimed to comprehensively review strategies for implementation of low back pain (LBP) guidelines, policies, and models of care in the Australian health care system. METHODS: A literature search was conducted in MEDLINE, EMBASE, CINAHL, Allied and Complementary Medicine Database, and Web of Science to identify studies that aimed to implement or integrate evidence-based interventions or practices to improve LBP care within Australian settings. RESULTS: Twenty-five studies met the inclusion criteria. Most studies targeted primary care settings (n = 13). Other settings included tertiary care (n = 4), community (n = 4), and pharmacies (n = 3). One study targeted both primary and tertiary care settings (n = 1). Only 40% of the included studies reported an underpinning framework, model, or theory. The implementation strategies most frequently used were evaluative and iterative strategies (n = 14, 56%) and train and educate stakeholders (n = 13, 52%), followed by engage consumers (n = 6, 24%), develop stakeholder relationships (n = 4, 16%), change in infrastructure (n = 4, 16%), and support clinicians (n = 3, 12%). The most common implementation outcomes considered were acceptability (n = 11, 44%) and adoption (n = 10, 40%), followed by appropriateness (n = 7, 28%), cost (n = 3, 12%), feasibility (n = 1, 4%), and fidelity (n = 1, 4%). Barriers included time constraints, funding, and teamwork availability. Facilitators included funding and collaboration between stakeholders. CONCLUSIONS: Implementation research targeting LBP appears to be a young field, mostly focusing on training and educating stakeholders in primary care. Outcomes on sustainability and penetration of evidence-based interventions are lacking. There is a need for implementation research guided by established frameworks that consider interrelationships between organizational and system contexts beyond the clinician-patient dyad.

What makes a great clinical trial in physiotherapy?

OBJECTIVE: To identify common characteristics of landmark physiotherapy clinical trials. METHODS: The Physiotherapy Evidence Database (PEDro) top five trials were compared to 91 physiotherapy trials published in top medical journals and 99 trials randomly selected from PEDro on the following characteristics: PEDro score, sample size, number of trial sites, use of prospective registration, positive or negative trial, citations, citations in guidelines, Altmetric score, impact factor, publications and citations of first and last author, and PEDro codes (sub-discipline, topic, problem, therapy, and body part). Trials were published from 2014 to 2019. One-way independent ANOVA and Chi-squared test evaluated between-group differences. RESULTS: Compared to a random sample of physiotherapy trials, the PEDro top five trials and trials in top medical journals have higher PEDro scores, larger sample sizes, more study sites, more citations (including in guidelines), higher Altmetric scores, more likely to be prospectively registered, less likely to be positive trials, and have first and last authors with more citations and publications. The problem was the only PEDro code was distributed differently across the trial groups. CONCLUSION: The PEDro top five trials and physiotherapy trials published in the top medical journals have characteristics that may inform the design, conduct, and reporting of future physiotherapy trials.

Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial.

BACKGROUND: Although many people with chronic low back pain (LBP) improve following conservative treatment, one in five will experience worsening symptoms after discharge from treatment and seek health care again. The current LBP clinical care pathway in many health services lacks a well-integrated, systematic approach to support patients to remain physically active and self-manage their symptoms following discharge from treatment. Health coaching can support people to improve physical activity levels and may potentially reduce health care utilisation for LBP. The primary aim of this study is to evaluate the effect of introducing a coordinated support system (linking hospital outpatient physiotherapy services to a public health coaching service) at discharge from LBP treatment, on the future use of hospital, medical, and health services for LBP, compared with usual care provided at discharge. METHODS: Three hundred and seventy-four adults with chronic non-specific LBP will be recruited from the outpatient physiotherapy departments of public hospitals in New South Wales, Australia. Participants will be individually randomised to a support system (n = 187) or usual care group (n = 187). All participants will receive usual care provided at discharge from treatment. Participants allocated to the support system will also receive up to 10 telephone-based health coaching sessions, delivered by the Get Healthy Service®, over a 6-month period. Health coaches will monitor and support participants to improve physical activity levels and achieve personal health-related goals. The primary outcome is the total number of encounters with hospital, medical, and health services for LBP, at 12 months from baseline. A within-trial economic evaluation will quantify the incremental costs and benefits of the support system from a health system perspective, to support reimbursement decision making. DISCUSSION: This study will establish the effect of a coordinated support system, introduced at discharge from treatment, on the future use of hospital, medical, and health services for LBP and various health outcomes. CONCLUSION: Innovative community-driven solutions to support people with chronic LBP after discharge from treatment are urgently needed. Study findings will help inform health care policy and clinical practice in Australia. TRIAL REGISTRATION: Prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12620000889954 ) on 10/09/2020.

Parental Multisite Chronic Pain and the Risk of Adult Offspring Developing Additional Chronic Pain Sites: Family-Linkage Data From the Norwegian HUNT Study.

We investigated if parental multisite chronic pain increases the risk of adult offspring developing additional chronic pain sites, and if offspring body mass index (BMI) and leisure time physical activity modify this association. We used longitudinal data on 7,654 offspring linked with their parents who participated in the population-based HUNT Study (Norway) in 1995 to 1997 and 2006 to 2008. Logistic regression was used to estimate odds ratios (ORs) with 95% confidence interval (CI). One-third of offspring (n = 2,573) developed additional chronic pain sites. Having both parents with 1-2 chronic pain sites increased the risk of developing additional pain sites compared to having parents free of chronic pain (OR = 1.33; 95% CI 1.05-1.68), with larger effects observed when both parents had ≥3 chronic pain sites (OR = 1.46; 95% CI 1.17-1.82). These associations were largely driven by maternal pain, that is, there was no association between paternal chronic pain and risk of additional pain sites in offspring. The parent-offspring transfer of additional pain sites (when both parents had ≥3 pain sites) strengthened when offspring were obese (OR = 2.56; 95% CI 1.75-3.75) or physically inactive (OR = 1.73; 95% CI 1.33-2.27). In conclusion, parental multisite chronic pain increases the risk of offspring developing additional chronic pain sites, particularly those with obesity or inactivity. PERSPECTIVE: This longitudinal analysis investigated the parent-offspring transmission of multisite chronic pain, and whether lifestyle behaviors in offspring modify this association. The findings suggest that having parents with multisite chronic pain increases the risk of offspring developing additional chronic pain sites, particularly if offspring are obese or inactive.

Integrating Mobile-health, health coaching, and physical activity to reduce the burden of chronic low back pain trial (IMPACT): a pilot randomised controlled trial.

BACKGROUND: Low back pain is one of the most prevalent musculoskeletal conditions and the highest contributor to disability in the world. It is characterized by frequent relapses leading to additional care-seeking. Engagement in leisure physical activity is associated with lower recurrences and better prognosis and potentially reduced care-seeking. Our aim was to investigate the feasibility and preliminary efficacy of a patient-centred physical activity intervention, supported by health coaching and mobile health, to reduce care-seeking, pain and disability in patients with chronic low back pain after treatment discharge. METHODS: We conducted a pilot randomised controlled trial with blinded outcome assessment. Sixty-eight participants were recruited from four public outpatient physiotherapy departments and the general community in Sydney. The intervention group received a physical activity information booklet, plus one face-to-face and 12 telephone-based health coaching sessions. The intervention was supported by an internet-based application and an activity tracker (Fitbit). Control group (standard care) received the physical activity information booklet and advice to stay active. Feasibility measures included recruitment rate, intervention compliance, data completeness, and participant satisfaction. Primary outcomes were care-seeking, pain levels and activity limitation. Outcomes were assessed at baseline, 6-month follow-up and weekly for 6 months. RESULTS: Ninety potential participants were invited over 15 months, with 68 agreeing to take part (75%). Overall, 903 weekly questionnaires were answered by participants from a total of 1107 sent (89%). Participants were largely satisfied with the intervention (mean = 8.7 out of 10 on satisfaction scale). Intervention group participants had a 38% reduced rate of care-seeking (Incidence Rate Ratio (IRR): 0.62, 95% CI: 0.32 to 1.18, p = 0.14, using multilevel mixed-effects Poisson regression analysis) compared to standard care, although none of the estimates was statistically significant. No between groups differences were found for pain levels or activity limitation. CONCLUSION: The health coaching physical activity approach trialed here is feasible and well accepted by participants and may reduce care-seeking in patients with low back pain after treatment discharge, although further evaluation with an adequately powered trial is needed. TRIAL REGISTRATION: Australian and New Zealand Trial Registry ACTRN12615000189527 . Registered prospectively on 26-02-2015.

Treatment Effect Sizes of Mechanical Diagnosis and Therapy for Pain and Disability in Patients With Low Back Pain: A Systematic Review.

BACKGROUND: Mechanical Diagnosis and Therapy (MDT) is a treatment-based classification system founded on 3 core principles: classification into diagnostic syndromes, classification-based intervention, and appropriate application of force. Many randomized controlled trials have investigated the efficacy of MDT for low back pain; however, results have varied. The inconsistent delivery of MDT across trials may explain the different findings. OBJECTIVES: To compare treatment effect sizes for pain or disability between trials that delivered MDT consistent with the core principles of the approach and trials that met some or none of these principles. METHODS: In this systematic review, databases were searched from inception to June 2018 for studies that delivered MDT compared to nonpharmacological, conservative control interventions in patients with low back pain and reported outcomes of pain or disability. Studies were classified as "adherent" (meeting the core principles of MDT) or "nonadherent" (using some or none of the principles of MDT). Data were extracted by 2 independent reviewers. Meta-regression procedures were used to analyze the effect of delivery mode on clinical outcomes, adjusting for covariates of symptom duration (less than or greater than 3 months) and control intervention (minimal or active). RESULTS: Studies classified as adherent to the MDT approach showed greater reductions in pain and disability of 15.0 (95% confidence interval: 7.3, 22.7) and 11.7 (95% confidence interval: 5.4, 18.0) points, respectively, on a 100-point scale compared to nonadherent trials. CONCLUSION: This review provides preliminary evidence that treatment effects of MDT are greater when the core principles are followed. LEVEL OF EVIDENCE: Therapy, level 1a. J Orthop Sports Phys Ther 2019;49(4):219-229. Epub 13 Feb 2019. doi:10.2519/jospt.2019.8734.

Influence of family history on prognosis of spinal pain and the role of leisure time physical activity and body mass index: a prospective study using family-linkage data from the Norwegian HUNT study.

OBJECTIVES: To investigate the influence of parental chronic spinal pain on prognosis of chronic spinal pain in adult offspring, and whether offspring physical activity level and body mass index (BMI) modified this association. DESIGN: Prospective cohort study. SETTING: We used family-linked longitudinal data from the Norwegian HUNT study collected in HUNT2 (1995-1997) and HUNT3 (2006-2008). PARTICIPANTS: A total of 1529 offspring who reported spinal pain in HUNT2 were linked with parental data and followed up in HUNT3. OUTCOMES: We estimated relative risk (RR) with 95% CI for recovery from chronic spinal pain, and also from activity limiting spinal pain, in offspring related to chronic spinal pain in parents. We also investigated whether offspring leisure time physical activity and BMI modified these intergenerational associations in spinal pain. RESULTS: A total of 540 (35%) offspring were defined as recovered after approximately 11 years of follow-up. Offspring with both parents reporting chronic spinal pain were less likely to recover from chronic spinal pain (RR 0.83, 95% CI 0.69 to 0.99) and activity limiting spinal pain (RR 0.71, 95% CI 0.54 to 0.94), compared with offspring of parents without chronic spinal pain. Analyses stratified by BMI and physical activity showed no strong evidence of effect modification on these associations. However, offspring who were overweight/obese and with both parents reporting chronic spinal pain had particularly low probability of recovery from activity limiting spinal pain, compared with those who were normal weight and had parents without chronic spinal pain (RR 0.57, 95% CI 0.39 to 0.84). CONCLUSION: Offspring with chronic spinal pain are less likely to recover if they have parents with chronic spinal pain, particularly if offspring are overweight/obese.

What is the effect of health coaching on physical activity participation in people aged 60 years and over? A systematic review of randomised controlled trials.

BACKGROUND: Physical inactivity is common in older age, yet increased activity benefits older people in terms of preventing chronic disease and maximising independence. Health coaching is a behaviour change intervention that has been shown to increase physical activity in clinical populations. This systematic review and meta-analysis investigated the effect of health coaching on physical activity, mobility, quality of life and mood in older people. METHODS: MEDLINE, EMBASE, CENTRAL, PsycINFO, PEDro, SPORTDiscus, LILACS and CINAHL databases were used to identify randomised controlled trials which evaluated the effect of health coaching on physical activity (primary outcome) among people aged 60+. Secondary outcomes were mobility, quality of life and mood. We calculated standardised mean differences (SMDs, Hedges' g) with 95% CIs from random effects meta-analyses. RESULTS: 27 eligible trials were included. Health coaching had a small, statistically significant effect on physical activity (27 studies; SMD = 0.27; 95% CI 0.18 to 0.37; p<0.001). There was no evidence of an effect of health coaching on mobility (eight studies; SMD = 0.10; 95% CI -0.03 to 0.23; p=0.13), quality of life (eight studies; SMD = 0.07; 95% CI -0.06 to 0.20; p<0.05) or mood (five studies; SMD = 0.02; 95% CI -0.12 to 0.16; p=0.83). CONCLUSIONS: Health coaching significantly increased physical activity in people aged 60+. There was no evidence of an effect of health coaching on quality of life, mobility and mood, so different approaches may be required to impact on these outcomes.

Does sedentary behavior increase the risk of low back pain? A population-based co-twin study of Spanish twins.

BACKGROUND: The relationship between sedentary lifestyle and low back pain (LBP) remains unclear and previous research has not accounted for genetic and early environmental factors. PURPOSE: Our aim was to investigate if sedentary behavior is associated with the lifetime prevalence of persistent LBP and the risk of developing persistent LBP, care-seeking due to LBP, and activity limiting LBP when genetics and early environmental factors are accounted for. STUDY DESIGN: Both cross-sectional and longitudinal designs with a within-pair twin case-control were implemented. PATIENT SAMPLE: There were 2,148 twins included in the cross-sectional analysis whereas 1,098 twins free of persistent LBP at baseline were included in the longitudinal analysis. OUTCOME MEASURES: Sedentary behavior was the explanatory variable. Lifetime prevalence of LBP was the outcome variable in the cross-sectional analysis. The incidence of persistent LBP, care-seeking due to LBP, and activity limiting LBP were the outcome variables for the longitudinal analysis. METHODS: This observational study was supported by a grant in 2012. No competing interests were declared. RESULTS: In the cross-sectional analysis, sedentary behavior was slightly associated with an increased prevalence of persistent LBP in females but not in males. This association was not apparent when genetics and early environmental factors were accounted for. We acknowledge that the small sample included in the co-twin analyses have yielded wide confidence intervals, and that caution should be exercised when interpreting and an association may not be ruled out. In the longitudinal analysis, sedentary behavior did not significantly increase the risk of persistent LBP, care-seeking due to LBP, or activity limiting LBP. CONCLUSIONS: Sedentary behavior is associated with concurrent LBP. However, this association is weak; it only appears in females and decreases when accounting for genetics. Future studies using a twin design with larger samples should be conducted to further test these findings.

Integrating Mobile health and Physical Activity to reduce the burden of Chronic low back pain Trial (IMPACT): a pilot trial protocol.

BACKGROUND: It is well recognised that low back pain is a significant public health problem and engagement in moderate levels of physical activity is associated with positive outcomes. Conservative active care, such as exercise, is effective in reducing pain and disability associated with chronic low back pain. However, a rapid decline in clinical outcomes is commonly seen after discharge from treatment. METHODS/DESIGN: We will conduct a randomised controlled trial to investigate the effectiveness of a mobile health supported physical activity intervention (compared to standard care) in care-seeking, pain and disability in people with chronic low back pain after discharge from treatment. We will recruit 68 patients with chronic low back pain following discharge from an outpatient hospital program, who will be randomly allocated to the physical activity intervention (n = 34) or the standard care group (n = 34) and monitored for 6 months. The physical activity intervention will involve a physical activity advice booklet, a face-to-face health coaching session and 12 fortnightly follow-up telephone-based health coaching sessions. This intervention will be supported by provision of a specifically designed web app and a physical activity monitoring device (FitBit). The standard care group will receive the physical activity advice booklet only. DISCUSSION: This pilot trial will investigate a new model to prevent clinical decline in people following conservative treatment for chronic low back pain. If proven to be effective, this approach will constitute a major advance in the management of low back pain. Chronic patients who experience recurrent pain and disability after treatment are prone to seek additional care in the form of physiotherapy, medication, emergency department attendance, specialist consultation or spinal surgery. This model aims to maintain functional levels and reduce care-seeking empowering patients to self-manage their low back pain by offering them a contemporary patient-centred physical activity program with the support of mobile health technology. The outcomes of this trial will have immediate implications for clinical practice. TRIAL REGISTRATION: ACTRN12615000189527 (26-02-2015).