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BACKGROUND Scalable knee osteoarthritis programs are needed to deliver recommended education, exercise, and weight loss interventions. OBJECTIVE To evaluate two 6-month, telehealth-delivered exercise programs, 1 with and 1 without dietary intervention. DESIGN 3-group, parallel randomized (5:5:2) trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000930280). SETTING Australian private health insurance members. PARTICIPANTS 415 persons with symptomatic knee osteoarthritis and a body mass index between 28 and 40 kg/m2 who were aged 45 to 80 years. INTERVENTION All groups received access to electronic osteoarthritis information (control). The exercise program comprised 6 physiotherapist consultations via videoconference for exercise, self-management advice, and behavioral counseling, plus exercise equipment and resources. The diet and exercise program included an additional 6 dietitian consultations for a ketogenic very-low-calorie diet (2 formulated meal replacements and a low-carbohydrate meal daily) followed by a transition to healthy eating, as well as nutrition and behavioral resources. MEASUREMENTS Primary outcomes were changes in knee pain (numerical rating scale [NRS] of 0 to 10, higher indicating worse) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]; scale, 0 to 68, higher indicating worse) at 6 months (primary time point) and 12 months. Secondary outcomes were weight, physical activity, quality of life, mental health, global change, satisfaction, willingness to have surgery, orthopedic appointments, and knee surgery. RESULTS A total of 379 participants (91%) provided 6-month primary outcomes, and 372 (90%) provided 12-month primary outcomes. At 6 months, both programs were superior to control for pain (between-group mean difference in change on NRS: diet and exercise, -1.5 [95% CI, -2.1 to -0.8]; exercise, -0.8 [CI, -1.5 to -0.2]) and function (between-group mean difference in change on WOMAC: diet and exercise, -9.8 [CI, -12.5 to -7.0]; exercise, -7.0 [CI, -9.7 to -4.2]). The diet and exercise program was superior to exercise (pain, -0.6 [CI, -1.1 to -0.2]; function, -2.8 [CI, -4.7 to -0.8]). Findings were similar at 12 months. LIMITATION Participants and clinicians were unblinded. CONCLUSION Telehealth-delivered exercise and diet programs improved pain and function in people with knee osteoarthritis and overweight or obesity. A dietary intervention conferred modest additional pain and function benefits over exercise. PRIMARY FUNDING SOURCE Medibank, the Medibank Better Health Foundation Research Fund, and a National Health and Medical Research Council Centre of Research Excellence.

Although risk factors for new low back pain (LBP) episodes and acute-to-chronic transition have been identified, risk factors for flares of LBP remain largely unknown. This case-crossover study aimed to identify: (1) risk factors LBP flares and (2) whether risk factors differed when flare is defined by pain increase (pain-defined flare: PDF) or identified by participants according to a broader flare definition that considered emotions and coping (self-reported flare: SRF). One hundred and twenty-six participants with LBP for > 3 months were included. Candidate risk factors and flares (PDF/SRF) were assessed daily using a smartphone application for 28 days. Data on exposure to risk factors one, two and three days preceding PDF/SRF were compared to control periods. Conditional logistic regression estimated associations between risk factors and PDF/SRF. Odds of PDF and SRF were increased by poor sleep quality and morning pain. Good sleep quality reduced odds of flare. Odds for increased pain (PDF), but not SRF, were increased after days with higher afternoon and evening pain, fatigue, fear of physical activity and leisure physical activity. LBP flare has been largely ignored but is more reflective of the LBP experience than conventional definitions of acute, sub-acute and chronic LBP. This study highlights risk factors for flare and that these differ depending on whether flare is defined by pain alone (PDF) or a broad multidimensional definition (SRF). Potential targets to reduce the intensity/frequency of LBP flares are identified, with strong indication for the potential role of sleep intervention to mitigate LBP flare risk.

Summary Objective Different exercise types may yield different outcomes in osteoarthritis (OA) subgroups. The objective was to directly compare effectiveness of two exercise programs for people with medial knee OA and co-morbid obesity. Design We performed a participant- and assessor-blinded randomized controlled trial. 128 people ≥50 years with medial knee OA and body mass index ≥30 kg/m2 were recruited from the community. Interventions were home-based non-weight bearing (NWB) quadriceps strengthening or weight bearing (WB) functional exercise for 12 weeks. Primary outcomes were change in overall knee pain (numeric rating scale, range 0–10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0–68) over 12 weeks. Secondary outcomes included other pain measures, physical function, quality-of-life, global changes, physical performance, and lower-limb muscle strength. Results 123 (96%) participants were retained. There was no evidence of a between-group difference in change in pain (mean difference 0.73 units (95% confidence intervals (0.05,1.50)) or function (2.80 units (−1.17,6.76)), with both groups reporting improvements. For secondary outcomes, the WB group had greater improvement in quality-of-life (−0.043 units (−0.085,-0.001)) and more participants reporting global improvement (overall: relative risk 1.40 (0.98,2.01); pain 1.47 (0.97,2.24); function 1.43 (1.04,1.98). Although adverse events were minor, more NWB group participants reported ≥1 adverse event (26/66 (39%) vs 14/62 (23%), p = 0.04). Conclusions Both exercise types similarly improved primary outcomes of pain and function and can be recommended for people with knee OA and obesity. WB exercise may be preferred given fewer adverse events and potential additional benefits on some secondary outcomes. Registration Prospectively registered (Australian New Zealand Clinical Trials Registry #12617001013358, 14/7/2017).

Background Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. Methods Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and 2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12 months. Primary outcomes are self-reported knee pain and physical function at 6 months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed. Discussion This pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018).

Background Hand osteoarthritis is a common and disabling problem without effective therapies. Accumulating evidence suggests the role of local inflammation in causing pain and structural progression in hand osteoarthritis, and hand osteoarthritis with synovitis is a commonly encountered clinical phenotype. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether methotrexate reduces pain over 6 months in patients with hand osteoarthritis and synovitis. Methods Ninety-six participants with hand osteoarthritis and synovitis will be recruited through the Osteoarthritis Clinical Trial Network (Melbourne, Hobart, Adelaide, and Perth), and randomly allocated in a 1:1 ratio to receive either methotrexate 20 mg or identical placebo once weekly for 6 months. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 months. The secondary outcomes include changes in physical function and quality of life assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Health Assessment Questionnaire, Michigan Hand Outcomes Questionnaire, Short-Form-36, tender and swollen joint count, and grip strength, and structural progression assessed using progression of synovitis and bone marrow lesions from magnetic resonance imaging and radiographic progression at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to address whether methotrexate has an effect on reducing pain over 6 months in patients with hand osteoarthritis and synovitis, with major clinical and public health importance. While a positive trial will inform international clinical practice guidelines for the management of hand osteoarthritis, a negative trial would be highly topical and change current trends in clinical practice. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000877381. Registered 15 June 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373124

Overstating the impact of interventions through incomplete or inaccurate reporting can lead to inappropriate scale-up of interventions with low impact. Accurate reporting of the impact of interventions is of great importance in global health research to protect scarce resources. In global health, the cluster randomised trial design is commonly used to evaluate complex, multicomponent interventions, and outcomes are often binary. Complete reporting of impact for binary outcomes means reporting both relative and absolute measures. We did a systematic review to assess reporting practices and potential to overstate impact in contemporary cluster randomised trials with binary primary outcome. We included all reports registered in the Cochrane Central Register of Controlled Trials of two-arm parallel cluster randomised trials with at least one binary primary outcome that were published in 2017. Of 73 cluster randomised trials, most (60 [82%]) showed incomplete reporting. Of 64 cluster randomised trials for which it was possible to evaluate, most (40 [63%]) reported results in such a way that impact could be overstated. Care is needed to report complete evidence of impact for the many interventions evaluated using the cluster randomised trial design worldwide.

ObjectiveEvaluate a physiotherapist-led telephone-delivered exercise advice and support intervention for people with knee osteoarthritis.MethodsParticipant-blinded, assessor-blinded randomised controlled trial. 175 people were randomly allocated to (1) existing telephone service (≥1 nurse consultation for self-management advice) or (2) exercise advice and support (5–10 consultations with a physiotherapist trained in behaviour change for a personalised strengthening and physical activity programme) plus the existing service. Primary outcomes were overall knee pain (Numerical Rating Scale, range 0–10) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, range 0–68) at 6 months. Secondary outcomes, cost-effectiveness and 12-month follow-up were included.Results165 (94%) and 158 (90%) participants were retained at 6 and 12 months, respectively. At 6 months, exercise advice and support resulted in greater improvement in function (mean difference 4.7 (95% CI 1.0 to 8.4)), but not overall pain (0.7, 0.0 to 1.4). Eight of 14 secondary outcomes favoured exercise advice and support at 6 months, including pain on daily activities, walking pain, pain self-efficacy, global improvements across multiple domains (overall improvement, improved pain, improved function and improved physical activity) and satisfaction. By 12 months, most outcomes were similar between groups. Exercise advice and support cost $A514/participant and did not save other health service resources.ConclusionTelephone-delivered physiotherapist-led exercise advice and support modestly improved physical function but not the co-primary outcome of knee pain at 6 months. Functional benefits were not sustained at 12 months. The clinical significance of this effect is uncertain.Trial registration numberAustralian New Zealand Clinical Trials Registry (#12616000054415).

Chronic venous leg ulcers are challenging to heal and often recur. This has a significant impact on older individual health and is a financial burden on health care resources. This study aimed to identify factors associated with the healing of venous leg ulcers via secondary examination of data from a previously published prospective randomized controlled trial of elastic and inelastic compression systems. The data from the 45 patients who finished the trial was reanalyzed for a hypothesis generating study. Larger ulcers, higher exudate levels, larger calf circumferences, and longer ulcer duration at baseline were associated with lack of healing at 12 weeks. There was some evidence that NSAID use was associated with an increased likelihood of nonhealing (unadjusted OR for healing, 0.13, 95% CI (0.02, 0.70)). There was no evidence that other variables, including gender and BMI, were associated with healing. The key risk factors for wound healing are largely wound based or inherent to wound development, as these were found to be the factors with the strongest associations in the analysis. Future research should address how and why these factors are associated with wound healing over a longer time frame and explore how NSAIDs may affect wound healing outcomes.

BackgroundKnee osteoarthritis (OA) is a highly prevalent condition. People with knee OA often have other co-morbidities such as obesity. Exercise is advocated in all clinical guidelines for the management of knee OA. It is often undertaken as a home-based program, initially prescribed by a physiotherapist or other qualified health care provider. However, adherence to home-based exercise is often poor, limiting its ability to meaningfully change clinical symptoms of pain and/or physical function. While the efficacy of short message services (SMS) to promote adherence to a range of health behaviours has been demonstrated, its ability to promote home exercise adherence in people with knee OA has not been specifically evaluated. Hence, this trial is investigating whether the addition of an SMS intervention to support adherence to prescribed home-based exercise is more effective than no SMS on self-reported measures of exercise adherence.MethodsWe are conducting a two-arm parallel-design, assessor-and participant-blinded randomised controlled trial (ADHERE) in people with knee OA and obesity. The trial is enrolling participants exiting from another randomised controlled trial, the TARGET trial, where participants are prescribed a 12-week home-based exercise program (either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise) for their knee by a physiotherapist and seen five times over the 12 weeks for monitoring and supervision. Following completion of outcome measures for the TARGET trial, participants are immediately enrolled into the ADHERE trial. Participants are asked to continue their prescribed home exercise program unsupervised three times a week for 24-weeks and are randomly allocated to receive a behaviour change theory-informed SMS intervention to support home exercise adherence or to have no SMS intervention. Outcomes are measured at baseline and 24-weeks. Primary outcomes are self-reported adherence measures. Secondary outcomes include self-reported measures of knee pain, physical function, quality-of-life, physical activity, self-efficacy, kinesiophobia, pain catastrophising, participant-perceived global change and an additional adherence measure.DiscussionFindings will provide new information into the potential of SMS to improve longer-term exercise adherence and ultimately enhance exercise outcomes in knee OA.Trial registrationProspectively registered with the Australian New Zealand Clinical Trials Registry. Reference: ACTRN12617001243303Date/version:August 2019/two

Background Knee osteoarthritis (OA) is a prevalent and chronic condition with no known cure. Exercise is advocated in all clinical guidelines due to its positive effects on symptoms. Despite this, exercise participation is often poor in people with knee OA with access to exercise treatments a known barrier. Internet-delivered exercise interventions have the potential to improve access to evidence-based exercise treatments and can benefit OA outcomes, although non-usage and low adherence potentially limit their effectiveness. Short message services (SMS) show promise in facilitating exercise adherence and may be one solution to improve adherence to internet-delivered exercise interventions. The combination of internet-delivered exercise and SMS adherence support has not been specifically evaluated in people with knee OA. Methods This protocol reports a two-arm parallel-design, assessor- and participant-blinded randomised controlled trial. This trial is recruiting 206 people aged 45 years and older, with a clinical diagnosis of knee OA from the Australian-wide community. Eligible and consenting participants are enrolled and randomised to receive access to either i) ‘My Knee Education’, an education control website containing OA and exercise information only or ii) a combined intervention that includes a website, ‘My Knee Exercise’, containing the same educational information as the control, guidance to increase general physical activity, and the prescription of a 24-week self-directed home-based lower-limb strengthening program in addition to a 24-week behaviour change SMS exercise adherence program. Outcome measures are being collected at baseline and 24-weeks. Primary outcomes are self-reported knee pain and physical function. Secondary outcomes include another self-reported measure of knee pain, function in sport and recreation, quality-of-life, physical activity, self-efficacy, participant satisfaction and perceived global change. Discussion This randomised controlled trial will provide evidence about the effectiveness of a combined intervention of internet-delivered OA and exercise education, physical activity guidance and prescription of a 24-week lower-limb strengthening exercise program supported by a behaviour change SMS program compared to internet delivered OA and exercise education alone. Trial registration ACTRN12618001167257/13th July 2018. Electronic supplementary material The online version of this article (10.1186/s12891-019-2714-x) contains supplementary material, which is available to authorized users.

Objective The aim of the study was to evaluate whether a web-based exercise programming system improves adherence to a home exercise program for people with musculoskeletal conditions. Design Eligible patients with a musculoskeletal condition presenting to a physical therapist in private practice were randomized to the following: (a) control (home exercise prescribed by therapist’s usual methods) or (b) intervention (home exercise prescribed using a web-based exercise programming system). The primary outcome was self-rated exercise adherence measured at week 3 via 11-point Numeric Rating Scales. Secondary outcomes were satisfaction with exercise delivery and confidence in ability to undertake prescribed exercise. Process measures were also included. Results We enrolled 305 participants, with loss to follow-up of 14.5% (22/152) and 13.7% (21/153) in intervention and control groups, respectively. Compared with controls, the intervention group reported higher exercise adherence (mean difference Numeric Rating Scale units (95% confidence intervals): adherence overall −1.0 [−1.6 to −0.3] and regarding number of exercises in session −0.7 [−1.3 to −0.1], number of repetitions −0.8 [−1.4 to −0.2], and number of sessions −1.0 [−1.6 to −0.3]). The intervention group showed greater confidence to exercise than control, with no difference in satisfaction. Conclusions A web-based exercise programming system improved home exercise adherence and confidence in ability to undertake exercise, although the clinical relevance of the results needs to be established.

Objectives The aims of the present study were to determine how well physiotherapists implemented person-centred practice principles and behaviour change techniques after a workshop, and to evaluate whether self-audit of performance differed from audits of an experienced training facilitator. Methods Eight physiotherapists each completed a 2-day workshop followed by two telephone consultations with four patients with knee osteoarthritis. The training facilitator audited audio-recordings of all consultations, and therapists self-audited 50% of consultations using a tool comprising: (a) 10 person-centred practice principles rated on a numerical rating scale of 0 (need to work on this) to 10 (doing really well); and (b) seven behaviour change techniques rated with an ordinal scale (using this technique effectively; need to improve skill level; or need to learn how to apply this technique). Results Physiotherapists showed "moderate" fidelity to person-centred principles, with mean scores between 5 and 7 out of 10. For behaviour change techniques, the training facilitator believed that physiotherapists were using three of seven techniques "effectively" during most consultations and "needed to improve skill levels" with most other techniques. Physiotherapists scored themselves significantly lower than the training facilitator for two of 10 person-centred principles, and tended to rate their skills using behaviour change techniques less favourably. Conclusions Physiotherapists performed moderately well when implementing person-centred practice principles and behaviour change techniques immediately after training, but had room for improvement, particularly for skills relating to providing management options and changing thinking habits. Physiotherapists' self-ratings of performance generally did not differ from expert ratings; however, they underestimated their ability to implement some principles and techniques.

Exercise therapies are advocated in osteoarthritis (OA) clinical guidelines. However, challenges to accessing exercise may be limiting widespread uptake.To evaluate the effects of a self-directed web-based strengthening exercise and physical activity program supported by automated behavior-change text messages on knee pain and function for people with knee OA.The participant-blinded and assessor-blinded randomized clinical trial enrolled 206 people who met clinical criteria for knee OA in communities across Australia from July 2018 to August 2019, with follow-up taking place at 24 weeks.The control group was given access to a custom-built website with information on OA and the importance of exercise and physical activity. The intervention group was given access to the same information plus a prescription for a 24-week self-directed strengthening regimen and guidance to increase physical activity, supported by automated behavior-change text messages encouraging exercise adherence.Primary outcomes were change in overall knee pain (numeric rating scale, 0-10) and difficulty with physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0-68) over 24 weeks. Secondary outcomes were another knee pain measure, sport and recreation function, quality of life, physical activity, self-efficacy, overall improvement, and treatment satisfaction.Of 206 participants, 180 (87%; mean [SD] age, 60 [8.4] years; 109 [61%] women) completed both 24-week primary outcomes. The intervention group showed greater improvements in overall knee pain (mean difference, 1.6 units; 95% CI, 0.9-2.2 units; P .001) and physical function (mean difference, 5.2 units; 95% CI, 1.9-8.5 units; P = .002) compared with the control. There was evidence of differences in the proportion of participants exceeding the minimal clinically important improvement in pain (intervention group, 72.1%, vs control, 42.0%; risk difference, 0.30 [95% CI, 0.16-0.44]; P . 001) and function (intervention group, 68%, vs control, 40.8%; risk difference, 0.27 [95% CI, 0.13-0.41]; P .001) favoring the intervention. Between-group differences for all secondary outcomes favored the intervention except for physical activity, self-efficacy for function, and self-efficacy for exercise, for which there was no evidence of differences.This randomized clinical trial found that a self-directed web-based strengthening exercise regimen and physical activity guidance supported by automated behavior-change text messages to encourage exercise adherence improved knee pain and function at 24 weeks. This unsupervised, free-to-access digital intervention is an effective option to improve patient access to recommended OA exercise and/or to support clinicians in providing exercise management for people with knee OA at scale across the population.Australian New Zealand Clinical Trials Registry Identifier: ACTRN12618001167257.

BACKGROUND: Experts recommend that persons with knee osteoarthritis wear stable supportive shoes; however, evidence suggests that flat flexible shoes may be more beneficial. OBJECTIVE: To compare flat flexible with stable supportive shoes for knee osteoarthritis symptoms. DESIGN: Participant- and assessor-blinded randomized trial. (Prospectively registered with the Australian New Zealand Clinical Trials Registry [ACTRN12617001098325]). SETTING: Community. PARTICIPANTS: 164 patients with moderate to severe symptomatic radiographic medial knee osteoarthritis. INTERVENTION: Flat flexible (n = 82) or stable supportive shoes (n = 82), worn for at least 6 hours a day for 6 months. MEASUREMENTS: Primary outcomes were changes in walking pain (measured by an 11-point numerical rating scale) and physical function (as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale of 0 to 68 points) at 6 months. Secondary outcomes included additional pain and function measures, physical activity, and quality of life. Other measures included adverse events. RESULTS: Of 164 participants recruited, 161 (98%) completed 6-month primary outcomes. No evidence was found that flat flexible shoes were superior to stable supportive shoes in primary outcomes. Evidence did show a between-group difference in change in pain favoring stable supportive shoes (mean difference, 1.1 units [95% CI, 0.5 to 1.8 units]; P = 0.001) but not function (mean difference, 2.3 units [CI, -0.9 to 5.5 units]; P = 0.167). Improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes (mean difference, -5.3 units [CI, -10.0 to -0.5 units] and 0.7 units [CI, 0.0 to 1.4 units], respectively). Flat flexible shoes were not superior to stable supportive shoes for any secondary outcome. Fewer participants reported adverse events with stable supportive shoes (n = 12 [15%]) compared with flat flexible shoes (n = 26 [32%]) (risk difference, -0.17 [CI, -0.30 to -0.05]). LIMITATION: No "usual shoes" control group and a select patient subgroup, which may limit generalizability. CONCLUSION: Flat flexible shoes were not superior to stable supportive shoes. Contrary to our hypothesis, stable supportive shoes improved knee pain on walking more than flat flexible shoes. PRIMARY FUNDING SOURCE: National Health and Medical Research Council.

Background The therapeutic alliance between patients and physical therapists has been shown to influence clinical outcomes in patients with chronic low back pain when consulting in-person. However, no studies have examined whether the therapeutic alliance developed between patients with knee osteoarthritis and physical therapists during telephonic consultations influences clinical outcomes. Objective This study aims to investigate whether the therapeutic alliance between patients with knee osteoarthritis and physical therapists measured after the second consultation is associated with outcomes following telephone-delivered exercise and advice. Methods Secondary analysis of 87 patients in the intervention arm of a randomized controlled trial allocated to receive 5 to 10 telephone consultations with one of 8 physical therapists over a period of 6 months, involving education and prescription of a strengthening and physical activity program. Separate regression models investigated the association between patient and therapist ratings of therapeutic alliance (measured after the second consultation using the Working Alliance Inventory Short Form) and outcomes (pain, function, self-efficacy, quality of life, global change, adherence to prescribed exercise, physical activity) at 6 and 12 months, with relevant covariates included. Results There was some evidence of a weak association between patient ratings of the alliance and some outcomes at 6 months (improvements in average knee pain: regression coefficient −0.10, 95% CI −0.16 to −0.03; self-efficacy: 0.16, 0.04-0.28; global improvement in function: odds ratio 1.26, 95% CI 1.04-1.39, and overall improvement: odds ratio 1.26, 95% CI 1.06-1.51; but also with worsening in fear of movement: regression coefficient −0.13, 95% CI −0.23 to −0.04). In addition, there was some evidence of a weak association between patient ratings of the alliance and some outcomes at 12 months (improvements in self-efficacy: regression coefficient 0.15, 95% CI 0.03-0.27; global improvement in both function, odds ratio 1.19, 95% CI 0.03-1.37; and pain, odds ratio 1.14, 95% CI 1.01-1.30; and overall improvement: odds ratio 1.21, 95% CI 1.02-1.42). The data suggest that associations between therapist ratings of therapeutic alliance and outcomes were not strong, except for improved quality of life at 12 months (regression coefficient 0.01, 95% CI 0.0003-0.01). Conclusions Higher patient ratings, but not higher therapist ratings, of the therapeutic alliance were weakly associated with improvements in some clinical outcomes and with worsening in one outcome. Although the findings suggest that patients who perceive a stronger alliance with their therapist may achieve better clinical outcomes, the observed relationships were generally weak and unlikely to be clinically significant. The limitations include the fact that measures of therapeutic alliance have not been validated for use in musculoskeletal physical therapy settings. There was a risk of type 1 error; however, findings were interpreted on the basis of clinical significance rather than statistical significance alone. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12616000054415; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369204

ObjectivesTo test (i) if greater foot pronation (measured as midfoot width mobility) is associated with better outcomes with foot orthoses treatment, compared with hip exercises and (ii) if hip exercises are superior to foot orthoses, irrespective of midfoot width mobility.MethodsA two-arm parallel, randomised superiority clinical trial was conducted in Australia and Denmark. Participants (18–40 years) were included who reported an insidious onset of knee pain (≥6 weeks duration); ≥3/10 numerical pain rating, that was aggravated by activities (eg, stairs, squatting, running). Participants were stratified by midfoot width mobility (high ≥11 mm change in midfoot width) and site, randomised to foot orthoses or hip exercises and blinded to objectives and stratification. Success was defined a priori as much better or better on a patient-perceived 7-point scale at 12 weeks.ResultsOf 218 stratified and randomised participants, 192 completed 12-week follow-up. This study found no difference in success rates between foot orthoses versus hip exercises in those with high (6/21 vs 9/20; 29% vs 45%, respectively) or low (42/79 vs 37/72; 53% vs 51%) midfoot width mobility. There was no association between midfoot width mobility and treatment outcome (Interaction effect p=0.19). This study found no difference in success rate between foot orthoses versus hip exercises (48/100 vs 46/92; 48% vs 50%).ConclusionMidfoot width mobility should not be used to help clinicians decide which patient with patellofemoral pain might benefit most from foot orthoses. Clinicians and patients may consider either foot orthoses or hip exercises in managing patellofemoral pain.Trial registration numberACTRN12614000260628.

Background Exercise is a core recommended treatment for knee osteoarthritis (OA), yet adherence declines, particularly following cessation of clinician supervision. Objective This study aims to evaluate whether a 24-week SMS intervention improves adherence to unsupervised home exercise in people with knee OA and obesity compared with no SMS. Methods A two-group superiority randomized controlled trial was performed in a community setting. Participants were people aged 50 years with knee OA and BMI ≥30 kg/m2 who had undertaken a 12-week physiotherapist-supervised exercise program as part of a preceding clinical trial. Both groups were asked to continue their home exercise program unsupervised three times per week for 24 weeks and were randomly allocated to a behavior change theory–informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS). Primary outcomes were self-reported home exercise adherence at 24 weeks measured by the Exercise Adherence Rating Scale (EARS) Section B (0-24, higher number indicating greater adherence) and the number of days exercised in the past week (0-3). Secondary outcomes included self-rated adherence (numeric rating scale), knee pain, physical function, quality of life, global change, physical activity, self-efficacy, pain catastrophizing, and kinesiophobia. Results A total of 110 participants (56 SMS group and 54 no SMS) were enrolled and 99 (90.0%) completed both primary outcomes (48/56, 86% SMS group and 51/54, 94% no SMS). At 24 weeks, the SMS group reported higher EARS scores (mean 16.5, SD 6.5 vs mean 13.3, SD 7.0; mean difference 3.1, 95% CI 0.8-5.5; P=.01) and more days exercised in the past week (mean 1.8, SD 1.2 vs mean 1.3, SD 1.2; mean difference 0.6, 95% CI 0.2-1.0; P=.01) than the control group. There was no evidence of between-group differences in secondary outcomes. Conclusions An SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes. Trial Registration Australian New Zealand Clinical Trials Registry 12617001243303; https://tinyurl.com/y2ud7on5 International Registered Report Identifier (IRRID) RR2-10.1186/s12891-019-2801-z

Objective The term flare is commonly used to describe low back pain (LBP) fluctuations, but individuals with LBP consider that it does not always correspond to increased pain. This case cross-over study aimed to: (1) determine the extent to which days with a flare identified according to a multidimensional definition (self-reported flare, SRF) corresponded to days with greater than average pain (pain-defined flare, PDF) and (2) to investigate whether physical and psychosocial features differ between PDF and SRF. Materials and methods Individuals with LBP for ≥3 months (N=126) provided data on flares, physical, and psychosocial features daily for 28 days using a smartphone application. Results Most days with SRF (68%) did not have greater than average pain (ie, PDF), but most days with greater than average pain (64%) were reported as an SRF. On days with SRF-only all physical and psychosocial features were worse than nonflare days. SRF+PDF had lower sleep quality and higher pain intensity, fatigue, disability, pain catastrophizing, and fear avoidance than SRF-only. SRF+PDF had higher pain in the afternoon and evening, disability and pain catastrophizing than PDF-only. Self-efficacy at work and during leisure activities was worse on SRF+PDF days than SRF-only and PDF-only days. Discussion These findings highlight that when individuals with LBP consider they have a flare, they do not always have greater than average pain, but have worse psychosocial features. This emphasizes that flare has broader dimensions than pain alone. Consideration of flare according to broad dimensions is important when investigating symptom fluctuations across different LBP trajectories.

Background Approaches to routine diagnostic testing in the intensive care unit include time-scheduled testing and targeted testing. Blood tests and chest radiographs requested on a routine, time-scheduled basis may reduce the risk of missing important findings. Targeted testing, considering individual patient needs, may reduce unnecessary testing, wasted clinician time, and costs. However, existing evidence of targeted testing interventions is generally of low quality, and the optimal testing approach is uncertain. Objectives The aim of the study was to describe the development of an intervention to reduce unnecessary diagnostic test ordering by clinicians working in intensive care, with the aim of informing the design of a pivotal clinical trial. Methods The Capability, Opportunity, Motivation-Behaviour model was used as a theoretical framework for change. The intervention components were informed by systematically identifying, assessing, and classifying targeted testing interventions in behavioural terms. Feedback from intensive care clinicians and patients was sought using surveys and a consumer reference group. Results The mean percentage of routine tests considered unnecessary by 201 intensive care clinicians was 33 (standard deviation = 16). When presented with a statement of the pros and cons for targeted versus liberal testing (n = 154), 93 (60%) consumer survey respondents preferred a more liberal approach, 33 (21%) preferred a more restrictive approach, and 28 (18%) were unsure. There were 24 behavioural interventions identified and incorporated into the final intervention. This had five major components: (i) a management committee to acquire, disseminate, and coordinate intervention-related information, (ii) a targeted testing guideline for sites, (iii) educational material for sites, (iv) site medical and nursing champions, and (v) site audit and feedback. Conclusions Although surveyed intensive care clinicians report substantial unnecessary routine diagnostic testing, on the basis of currently available evidence, consumers prefer a more liberal approach. This feedback, and a framework to identify behavioural interventions, has been used to inform the design of a proposed targeted testing clinical trial.

Background Knee osteoarthritis (OA) is a global problem that causes significant pain and physical dysfunction, substantially impacting on quality of life and imposing enormous cost to the healthcare system. Exercise is pivotal to OA management, yet uptake by people with knee OA is inadequate. Limited access to appropriately skilled health professionals, such as physiotherapists, for prescription of an exercise program and support with exercise is a major barrier to optimal care. Internet-enabled video consultations permit widespread reach. However, services offering video consultations with physiotherapists for musculoskeletal conditions are scant in Australia where there is typically no Government or private health insurer funding for such services. The paucity of robust evidence demonstrating video consultations with physiotherapists are clinically effective, safe and cost-effective for knee OA is hampering implementation of, and willingness of healthcare policymakers to pay for, these services. Methods This is an assessor- and participant-blinded, two-arm, pragmatic, comparative effectiveness non-inferiority randomised controlled trial (RCT) conducted in Australia. We are recruiting 394 people from the community with chronic knee pain consistent with a clinical diagnosis of knee OA. Participants are randomly allocated to receive physiotherapy care via i) video-conferencing or; ii) face-to-face consultations. Participants are provided five consultations (30–45 min each) with a physiotherapist over 3 months for prescription of a home-based strengthening exercise program (to be conducted independently at home) and physical activity plan, as well as OA education. Participants in both groups are provided with educational booklets and simple exercise equipment via post. The co-primary outcomes are change in self-reported i) knee pain on walking; and ii) physical function, with a primary end-point of 3 months and a secondary end-point of 9 months. Secondary outcomes include changes in other clinical outcomes (health-related quality of life; therapeutic relationship; global ratings of change; satisfaction with care; self-efficacy; physical activity levels), time and financial costs of attending consultations, healthcare usage and convenience. Non-inferiority will be assessed using the per-protocol dataset. Discussion Findings will determine if video consultations with physiotherapists are non-inferior to traditional face-to-face consultations for management of people with knee OA. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12619001240134. http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377672&isReview=true

Objective: To evaluate the effects of financial incentives on physical activity (PA). Data Sources: MEDLINE, Embase, 7 other databases, and 2 trial registries until July 17, 2019. Study Inclusion and Exclusion Criteria: Randomized controlled trials with adults aged ≥18 years assessing the effect of financial incentives on PA. Any comparator was eligible provided the only difference between groups was the incentive strategy. Data Extraction: Two independent reviewers extracted data and assessed study quality. Of 5765 records identified, 57 records (51 unique trials; n = 17 773 participants) were included. Data Synthesis: Random-effects models pooling data for each of the 5 PA domains. Results: Financial incentives increase leisure time PA (gym or class attendance; standardized mean difference [95% CI], 0.46 [0.28-0.63], n = 5057) and walking behavior (steps walked; 0.25 [0.13-0.36], n = 3254). No change in total minutes of PA (0.52 [−0.09 to 1.12], n = 968), kilocalories expended (0.19 [−0.06 to 0.44], n = 247), or the proportion of participants meeting PA guidelines (risk ratio [95% CI] 1.53 [0.53-4.44], n = 650) postintervention was observed. After intervention has ceased, incentives sustain a slight increase in leisure time PA (0.10 [0.02-0.18], n = 2678) and walking behavior (0.11 [0.00-0.22], n = 2425). Conclusions: Incentives probably improve leisure time PA and walking at intervention end, and small improvements may be sustained over time once incentives have ceased. They lead to little or no difference in kilocalories expended or minutes of PA. It is uncertain whether incentives change the likelihood of meeting PA guidelines because the certainty of the evidence is low.

Background The aim of this study was to examine the relationship between psychological characteristics and physical activity levels, measured as the average number of steps per day, in people with knee osteoarthritis (OA). Methods This study analysed baseline data from a randomized controlled trial (Australian New Zealand Clinical Trials Registry reference: ACTRN12612000308897). A total of 167 adults aged over 50 years, with knee pain rated as four or more on an 11-point numeric rating scale, and knee OA diagnosed using American College of Rheumatology clinical criteria, were recruited from the community (62 men and 105 women, mean age, 62.2 ± 7.5 years). The average number of steps per day over seven consecutive days was measured using an accelerometer-based device. Psychological characteristics evaluated were: depressive symptoms (Depression Anxiety Stress Scale), self-efficacy (Arthritis Self-Efficacy Scale for pain and other symptoms), fear of movement (Brief Fear of Movement Scale for Osteoarthritis), and pain catastrophizing (Pain Catastrophizing Scale). The association between the average number of steps per day and psychological characteristics was analyzed using a multiple linear regression analysis, with the average number of steps per day as the dependent variable, adjusting for each psychological characteristic separately, and age, sex, body mass index, and pain entered as covariates. Results There was evidence that the amount of physical activity was associated with fear of movement (coefficient [B]: − 117, 95% confidence interval [95%CI]: − 227 to − 8) and with pain catastrophizing (B: -44, 95%CI: − 86 to − 1). The association with self-efficacy was similar (B:117, 95%CI: − 12 to 246). However, the direction of the association with depressive symptoms was less clear (B: -59, 95%CI: − 138 to 19). Conclusions The results of this study revealed that the relationship was such that lower fear of movement and lower pain catastrophizing may be associated with more steps per day. It may be hypothesized that fear of moving and pain catastrophizing lead to activity avoidance and that strategies to improve these disease-related psychological aspects may be useful in enhancing physical activity participation, although this hypothesis is highly speculative and needs further testing given the cross-sectional design of this study.

Background Structural features of lateral tibiofemoral (TF) joint osteoarthritis (OA) occur in up to half of all people with knee OA, and co-existing lateral TF OA is associated with worse knee pain in people with mixed compartmental knee OA. Clinical guidelines for management of knee OA advocate advice about appropriate footwear, yet there is no research evaluating which types of footwear are best for managing pain associated with lateral TF OA. Biomechanical evidence suggests that “motion-control” footwear, which possess midsoles that are stiffer medially compared to laterally, may shift load away from the lateral compartment of the knee and thus may reduce knee pain associated with lateral TF OA. The primary aim of this study is to compare the effects of motion-control shoes to neutral shoes on knee pain in people with predominantly lateral TF OA. Methods This will be an assessor- and participant-blinded, two-arm, comparative effectiveness randomized controlled trial (RCT) conducted in Melbourne, Australia. We will recruit a minimum of 92 people with painful lateral TF OA from the community. Participants will be randomly allocated to receive either motion-control shoes or neutral shoes and will be instructed to wear their allocated shoes for a minimum of 6 h per day for 6 months. The primary outcome is change in self-reported knee pain on walking, measured using a numerical rating scale, assessed at baseline and 6 months. Secondary outcomes include other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity levels. Discussion This study will compare the efficacy of motion-control shoes to neutral shoes for people with painful lateral TF OA. Findings will be the first to provide evidence of the effects of footwear on knee pain in this important subgroup of people with knee OA and allow clinicians to provide accurate advice about the most appropriate footwear for managing pain associated with lateral TF OA. Trial registration This trial has been prospectively registered by the Australian New Zealand Clinical Trials Registry on 15/11/2018 (reference: ACTRN12618001864213).

Background There is no physiotherapy-specific quality indicator tool available to evaluate physiotherapy care for people with hip and/or knee osteoarthritis (OA). This study aimed to develop a patient-reported quality indicator tool (QUIPA) for physiotherapy management of hip and knee OA and to assess its reliability and validity. Methods To develop the QUIPA tool, quality indicators were initially developed based on clinical guideline recommendations most relevant to physiotherapy practice and those of an existing generic OA quality indicator tool. Draft items were then further refined using patient focus groups. Test-retest reliability, construct validity (hypothesis testing) and criterion validity were then evaluated. Sixty-five people with hip and/or knee OA attended a single physiotherapy consultation and completed the QUIPA tool one, twelve- and thirteen-weeks after. Physiotherapists (n = 9) completed the tool post-consultation. Patient test-retest reliability was assessed between weeks twelve and thirteen. Construct validity was assessed with three predefined hypotheses and criterion validity was based on agreement between physiotherapists and participants at week one. Results A draft list of 23 clinical guideline recommendations most relevant to physiotherapy was developed. Following feedback from three patient focus groups, the final QUIPA tool contained 18 items (three subscales) expressed in lay language. The test-retest reliability estimates (Cohen’s Kappa) for single items ranged from 0.30–0.83 with observed agreement of 64–94%. The intraclass correlation coefficient (ICC) and 95% confidence interval (CI) for the Assessment and Management Planning subscale was 0.70 (0.54, 0.81), Core Recommended Treatments subscale was 0.84 (0.75, 0.90), Adjunctive Treatments subscale was 0.70 (0.39, 0.87) and for the total QUIPA score was 0.80 (0.69, 0.88). All predefined hypotheses regarding construct validity were confirmed. However, agreement between physiotherapists and participants for single items showed large measurement error (Cohen’s Kappa estimates ranged from − 0.04-0.59) with the ICC (95% CI) for the total score being 0.11 (− 0.14, 0.34). Conclusions The QUIPA tool showed acceptable test-retest reliability for subscales and total score but inadequate reliability for individual items. Construct validity was confirmed but criterion validity for individual items, subscales and the total score was inadequate. Further research is needed to refine the QUIPA tool to improve its clinimetric properties before implementation.

Background Attrition due to death and non-attendance are common sources of bias in studies of age-related diseases. A simulation study is presented to compare two methods for estimating the survivor average causal effect (SACE) of a binary exposure (sex-specific dietary iron intake) on a binary outcome (age-related macular degeneration, AMD) in this setting. Methods A dataset of 10,000 participants was simulated 1200 times under each scenario with outcome data missing dependent on measured and unmeasured covariates and survival. Scenarios differed by the magnitude and direction of effect of an unmeasured confounder on both survival and the outcome, and whether participants who died following a protective exposure would also die if they had not received the exposure (validity of the monotonicity assumption). The performance of a marginal structural model (MSM, weighting for exposure, survival and missing data) was compared to a sensitivity approach for estimating the SACE. As an illustrative example, the SACE of iron intake on AMD was estimated using data from 39,918 participants of the Melbourne Collaborative Cohort Study. Results The MSM approach tended to underestimate the true magnitude of effect when the unmeasured confounder had opposing directions of effect on survival and the outcome. Overestimation was observed when the unmeasured confounder had the same direction of effect on survival and the outcome. Violation of the monotonicity assumption did not increase bias. The estimates were similar between the MSM approach and the sensitivity approach assessed at the sensitivity parameter of 1 (assuming no survival bias). In the illustrative example, high iron intake was found to be protective of AMD (adjusted OR 0.57, 95% CI 0.40–0.82) using complete case analysis via traditional logistic regression. The adjusted SACE odds ratio did not differ substantially from the complete case estimate, ranging from 0.54 to 0.58 for each of the SACE methods. Conclusions On average, MSMs with weighting for exposure, missing data and survival produced biased estimates of the SACE in the presence of an unmeasured survival-outcome confounder. The direction and magnitude of effect of unmeasured survival-outcome confounders should be considered when assessing exposure-outcome associations in the presence of attrition due to death.

This assessor-, therapist-, and participant-blinded randomised controlled trial evaluated the effects of an automated internet-based pain coping skills training (PCST) program before home exercise for people with clinically diagnosed hip osteoarthritis. One hundred forty-four people were randomised to either the PCST group or the comparator group. In the first 8 weeks, the PCST group received online education and PCST, whereas the comparison group received online education only. From weeks 8 to 24, both groups visited a physiotherapist 5 times for home exercise prescription. Assessments were performed at baseline, 8, 24, and 52 weeks. Primary outcomes were hip pain on walking (11-point numerical rating scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) at 24 weeks. Secondary outcomes were other measures of pain, quality-of-life, global change, self-efficacy, pain coping, pain catastrophizing, depression, anxiety, stress, physical activity, and adverse events. Primary outcomes were completed by 137 (95%), 131 (91%), and 127 (88%) participants at 8, 24, and 52 weeks, respectively. There were no significant between-group differences in primary outcomes at week 24 (change in: walking pain [mean difference 0.5 units; 95% confidence interval, -0.3 to 1.3] and function [-0.9 units; 95% confidence interval, -4.8 to 2.9]), with both groups showing clinically relevant improvements. At week 8, the PCST group had greater improvements in function, pain coping, and global improvement than comparison. Greater pain coping improvements persisted at 24 and 52 weeks. In summary, online PCST immediately improved pain coping and function but did not confer additional benefits to a subsequent exercise program, despite sustained pain coping improvements.

Summary Objective To determine if an increase in knee extensor strength mediates the effect of a 12-week knee extensor strength training program on pain and physical function improvement in people with knee osteoarthritis (OA). Design Secondary analysis from a randomised controlled trial comparing the effects of a 12-week knee extensor strengthening exercise program to a control group with no intervention. Methods Data from participants with complete data ( n = 97) enrolled in a previous clinical trial were analysed. Baseline and 12-week follow-up assessments included peak isometric knee extensor strength, pain and physical function. Peak knee extensor strength (Nm/kg) was assessed on an isokinetic dynamometer and subscales of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index were used to assess pain and physical function. Twelve-week change in pain and physical function were regressed separately, on 12-week change in knee extensor strength and group allocation. Covariates included baseline pain or physical function as appropriate, and baseline knee extensor strength, age, sex and knee alignment (stratification variable). Results Improved knee extensor strength mediated the effect of the strengthening program on both pain relief (mediated effect size = 0.69, 95% confidence intervals (CI) 0.05–1.33, P = 0.03), and improved physical function (mediated effect size = 1.86, 95% CI 0.08–3.64, P = 0.04), at 12 weeks. Conclusions Increased knee extensor strength partially mediates the effect of a knee extensor strength training program on pain and physical function improvement in people with knee OA.

Objective. Investigate physical therapists' perceptions of, and willingness to use, telephone- and internet-mediated service models for exercise therapy for people with knee and/or hip osteoarthritis. Methods. An internet-based survey of Australian physical therapists comprising three sections: i) demographic information; and 16 positively-framed perception statements about delivering exercise via ii) telephone and; iii) video over the internet, for people with hip and/or knee osteoarthritis. Levels of agreement with each statement were evaluated. Logistic regression models were used to determine therapist characteristics influencing interest in delivering telerehabilitation. Results. 217 therapists spanning metropolitan, regional, rural and remote Australia completed the survey. For telephone-delivered care, there was consensus agreement it would not violate patient privacy (81% agreed/strongly agreed) and would save patient's time (76%), however there was less than majority agreement for 10 statements. There was consensus agreement video-delivered care would save a patient's time (82%), be convenient for patients (80%), and not violate patient privacy (75%). Most agreed with all other perception statements about video-delivered care, except for liking no physical contact (14%). Low confidence using internet video technologies, and inexperience with telerehabilitation, were significantly associated with reduced interest in delivering telephone and/or video-based services. Conclusion. Physical therapists agree telerehabilitation offers time-saving and privacy advantages for people with osteoarthritis, and perceive video-delivered care more favorably than telephone-delivered services. However, most do not like the lack of physical contact with either service model. These findings may inform the implementation of telerehabilitation osteoarthritis services, and the training needs of clinicians involved in delivering care. This article is protected by copyright. All rights reserved.

Importance Most clinical guidelines do not recommend platelet-rich plasma (PRP) for knee osteoarthritis (OA) because of lack of high-quality evidence on efficacy for symptoms and joint structure, but the guidelines emphasize the need for rigorous studies. Despite this, use of PRP in knee OA is increasing. Objective To evaluate the effects of intra-articular PRP injections on symptoms and joint structure in patients with symptomatic mild to moderate radiographic medial knee OA. Design, setting, and participants This randomized, 2-group, placebo-controlled, participant-, injector-, and assessor-blinded clinical trial enrolled community-based participants (n = 288) aged 50 years or older with symptomatic medial knee OA (Kellgren and Lawrence grade 2 or 3) in Sydney and Melbourne, Australia, from August 24, 2017, to July 5, 2019. The 12-month follow-up was completed on July 22, 2020. Interventions Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor PRP using a commercially available product (n = 144 participants) or saline placebo (n = 144 participants). Main outcomes and measures The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in medial tibial cartilage volume as assessed by magnetic resonance imaging (MRI). Thirty-one secondary outcomes (25 symptom related and 6 MRI assessed; minimum clinically important difference not known) evaluated pain, function, quality of life, global change, and joint structures at 2-month and/or 12-month follow-up. Results Among 288 patients who were randomized (mean age, 61.9 [SD, 6.5] years; 169 [59%] women), 269 (93%) completed the trial. In both groups, 140 participants (97%) received all 3 injections. After 12 months, treatment with PRP vs placebo injection resulted in a mean change in knee pain scores of -2.1 vs -1.8 points, respectively (difference, -0.4 [95% CI, -0.9 to 0.2] points; P = .17). The mean change in medial tibial cartilage volume was -1.4% vs -1.2%, respectively (difference, -0.2% [95% CI, -1.9% to 1.5%]; P = .81). Of 31 prespecified secondary outcomes, 29 showed no significant between-group differences. Conclusions and relevance Among patients with symptomatic mild to moderate radiographic knee OA, intra-articular injection of PRP, compared with injection of saline placebo, did not result in a significant difference in symptoms or joint structure at 12 months. These findings do not support use of PRP for the management of knee OA. Trial registration Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617000853347.

Background The internet is used for information related to health conditions, including low back pain (LBP), but most LBP websites provide inaccurate information. Few studies have investigated the effectiveness of internet resources in changing health literacy or treatment choices. Objective This study aims to evaluate the effectiveness of the MyBackPain website compared with unguided internet use on health literacy, choice of treatments, and clinical outcomes in people with LBP. Methods This was a pragmatic, web-based, participant- and assessor-blinded randomized trial of individuals with LBP stratified by duration. Participants were randomly allocated to have access to the evidence-based MyBackPain website, which was designed with input from consumers and expert consensus or unguided internet use. The coprimary outcomes were two dimensions of the Health Literacy Questionnaire (dimension 2: “having sufficient information to manage my health;” dimension 3: “actively managing my health;” converted to scores 1-100) at 3 months. Secondary outcomes included additional Health Literacy Questionnaire dimensions, quality of treatment choices, and clinical outcomes. Results A total of 453 participants were recruited, and 321 (70.9%) completed the primary outcomes. Access to MyBackPain was not superior to unguided internet use on primary outcomes (dimension 2: mean difference −0.87 units, 95% CI −3.56 to 1.82; dimension 3: mean difference −0.41 units, 95% CI −2.78 to 1.96). Between-group differences in other secondary outcomes had inconsistent directions and were unlikely to be clinically important, although a small improvement of unclear importance in the quality of stated treatment choices at 1 month was found (mean difference 0.93 units, 95% CI 0.03 to 1.84). Conclusions MyBackPain was not superior to unguided internet use for health literacy, but data suggest some short-term improvement in treatment choices. Future research should investigate if greater interactivity and engagement with the website may enhance its impact. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12617001292369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372926 International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2018-027516

Objective\ud To assess whether foot and/or ankle symptoms are associated with an increased risk of worsening of knee pain and radiographic change in people with knee osteoarthritis (OA).\ud \ud Methods\ud The presence and laterality of foot/ankle symptoms were recorded at baseline in 1368 participants from the Osteoarthritis Initiative (OAI) with symptomatic radiographic knee OA. Knee pain severity (measured using the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale) and minimum medial tibiofemoral joint space (minJSW) width measured on X-ray were assessed yearly over the subsequent 4 years. Associations between foot/ankle symptoms and worsening of (1) knee pain, and (2) both knee pain and minJSW (i.e., symptomatic radiographic knee OA) were assessed using logistic regression.\ud \ud Results\ud Foot/ankle symptoms in either foot/ankle significantly increased the odds of knee pain worsening (adjusted OR 1.54, 95% CI 1.25 to 1.91). Laterality analysis showed ipsilateral (adjusted OR 1.50, 95% CI 1.07 to 2.10), contralateral (adjusted OR 1.44, 95% CI 1.02 to 2.06) and bilateral foot/ankle symptoms (adjusted OR 1.61, 95% CI 1.22 to 2.13) were all associated with knee pain worsening in the follow up period. There was no association between foot/ankle symptoms and worsening of symptomatic radiographic knee OA.\ud \ud Conclusion\ud The presence of foot/ankle symptoms in people with symptomatic radiographic knee OA was associated with increased risk of knee pain worsening, but not worsening of symptomatic radiographic knee OA, over the subsequent 4 years. Future studies should investigate whether treatment of foot/ankle symptoms reduces the risk of knee pain worsening in people with knee OA.

Objective\ud To investigate whether foot and/or ankle symptoms increase the risk of developing (1) knee symptoms and (2) symptomatic radiographic knee osteoarthritis (OA).\ud \ud Design\ud 1020 Osteoarthritis Initiative (OAI) participants who were at-risk of knee OA, but were without knee symptoms or radiographic knee OA, were investigated. Participants indicated the presence and laterality of foot/ankle symptoms at baseline. The main outcome was development of knee symptoms (pain, aching or stiffness in and around the knee on most days of the month for at least 1 month in the past year). A secondary outcome was development of symptomatic radiographic knee OA (symptoms plus Kellgren and Lawrence [KL] grade ≥2), over the subsequent 4 years. Associations between foot/ankle symptoms and study outcomes were assessed by logistic regression models.\ud \ud Results\ud Foot/ankle symptoms in either or both feet significantly increased the odds of developing knee symptoms (adjusted odds ratio (OR) 1.55, 95% confidence interval (CI) 1.10 to 2.19), and developing symptomatic radiographic knee OA (adjusted OR 3.28, 95% CI 1.69 to 6.37). Based on laterality, contralateral foot/ankle symptoms were associated with developing both knee symptoms (adjusted OR 1.68, 95% CI 1.05 to 2.68) and symptomatic radiographic knee OA (adjusted OR 3.08, 95% CI 1.06 to 8.98), whilst bilateral foot/ankle symptoms were associated with developing symptomatic radiographic knee OA (adjusted OR 4.02, 95% CI 1.76 to 9.17).\ud \ud Conclusion\ud In individuals at-risk of knee OA, the presence of contralateral foot/ankle symptoms in particular increases risk of developing both knee symptoms and symptomatic radiographic knee OA.

The administration of chloride-rich intravenous (IV) fluid and hyperchloraemia have been associated with perioperative renal injury. The aim of this study was to determine whether a comprehensive perioperative protocol for the administration of chloride-limited IV fluid would reduce perioperative renal injury in adults undergoing cardiac surgery. From February 2014 through to December 2015, all adult patients undergoing cardiac surgery within a single academic medical center received IV fluid according to the study protocol. The perioperative protocol governed all fluid administration from commencement of anesthesia through to discharge from the intensive care unit and varied over four sequential periods, each lasting 5 months. In periods 1 and 4 a chloride-rich strategy, consisting of 0.9% saline and 4% albumin, was adopted; in periods 2 and 3, a chloride-limited strategy, consisting of a buffered salt solution and 20% albumin, was used. Co-primary outcomes were peak delta serum creatinine (∆SCr) within 5 days after the operation and KDIGO-defined stage 2 or stage 3 acute kidney injury (AKI) within 5 days after the operation. We enrolled and analysed data from 1136 patients, with 569 patients assigned to a chloride-rich fluid strategy and 567 to a chloride-limited one. Compared with a chloride-limited strategy and adjusted for prespecified covariates, there was no association between a chloride-rich perioperative fluid strategy and either peak ∆S Cr, transformed to satisfy the assumptions of multivariable linear regression [regression coefficient 0.03, 95% confidence interval (CI) −0.03 to 0.08); p = 0.39], or stage 2 or 3 AKI (adjusted odds ratio 0.97, 95% CI 0.65–1.47; p = 0.90]. A perioperative fluid strategy to restrict IV chloride administration was not associated with an altered incidence of AKI or other metrics of renal injury in adult patients undergoing cardiac surgery. Trial Registration: Clinicaltrials.gov Identifier: NCT02020538.

To validate simple criteria that distinguish flat flexible from stable supportive walking shoes by comparing their effects on the knee adduction moment (KAM) in people with medial knee osteoarthritis (OA).This was a cross-sectional biomechanical study. We proposed five criteria to differentiate flat flexible from stable supportive shoes, and selected three pairs of shoes representing each class for biomechanical testing. 28 participants aged ≥50 years with symptomatic medial knee OA underwent gait analysis barefoot and wearing each of the six selected shoes, in random order. Differences in the peak KAM, KAM impulse and peak knee flexion moment (KFM) across test conditions were evaluated with a two-way repeated measures analysis of variance (ANOVA). Immediate changes in walking pain between conditions were also compared.Increases in KAM from barefoot were lower with each of the three flat flexible shoe styles (peak KAM: 6.1-8.9%; KAM impulse: 2.4-5.1%) compared to their stable supportive counterparts (peak KAM: 11.6-15.1%; KAM impulse 10.5-13.2%). There was a significant main effect for footwear class on peak KAM and KAM impulse, whereby stable supportive shoes increased the KAM significantly more than flat flexible shoes (P 0.001). There were no differences in the KFM or immediate walking pain between footwear classes.Our proposed criteria can be used by researchers and clinicians to select flat flexible shoes for people with medial knee OA to minimise knee loading. Future research should evaluate whether wearing shoes based on these criteria translates to improvements in knee OA symptoms and/or slows structural disease progression.

Introduction This study aimed to evaluate associations between strength of selected hip and knee muscles and self-reported physical function, and their clinical relevance, in men and women with hip osteoarthritis (OA). Methods Cross-sectional data from 195 participants with symptomatic hip OA were used. Peak isometric torque of hip extensors, flexors, and abductors, and knee extensors were measured, along with physical function using the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. Separate linear regressions in men and women were used to determine the association between strength and physical function accounting for age, pain, and radiographic disease severity. Subsequently, magnitudes of strength associated with estimates of minimal clinically important improvement (MCII) in physical function were estimated according to severity of difficulty with physical function. Results For men, greater strength of the hip extensors, hip flexors and knee extensors were each associated with better physical function. For women, greater muscle strength of all tested muscles were each associated with better physical function. For men and women, increases in muscle strength between 17–32%, 133–223%, and 151–284% may be associated with estimates of MCII in physical function for those with mild, moderate, and severe physical dysfunction, respectively. Conclusion Greater isometric strength of specific hip and thigh muscle groups may be associated with better self-reported physical function in men and women. In people with mild physical dysfunction, an estimate of MCII in physical function may be associated with attainable increases in strength. However, in patients with more severe dysfunction, greater and perhaps unattainable strength increases may be associated with an estimate of MCII in physical function. Longitudinal studies are required to validate these observations.

Background Service models for gastrointestinal endoscopy sedation must be safe, as endoscopy is the most common procedure performed under sedation in many countries. The aim of this prospective cohort study was to determine the patient risk profile, and incidence of and risk factors for significant unplanned events, in adult patients presenting for gastrointestinal endoscopy in a group of university-affiliated hospitals where most sedation is managed by anaesthetists. Methods Patients aged ≥18 yr presenting for elective and emergency gastrointestinal endoscopy under anaesthetist-managed sedation at nine hospitals affiliated with the University of Melbourne, Australia, were included. Outcomes included significant airway obstruction, hypoxia, hypotension and bradycardia; unplanned tracheal intubation; abandoned procedure; advanced life support; prolonged post-procedure stay; unplanned over-night admission and 30-day mortality. Results 2,132 patients were included. Fifty percent of patients were aged >60 yr, 50% had a BMI >27 kg m −2, 42% were ASA physical status III-V and 17% were emergency patients. The incidence of significant unplanned events was 23.0% (including significant hypotension 11.8%). Significant unplanned intraoperative events were associated with increasing age, BMI Conclusions Patients presenting for gastrointestinal endoscopy at a group of public university-affiliated hospitals where most sedation is managed by anaesthetists, had a high risk profile and a substantial incidence of significant unplanned intraoperative events and 30-day mortality.

Summary Objective To investigate relationships between external knee adduction moment parameters (KAM) and osteoarthritis (OA) symptoms according to disease severity. Design 164 participants with symptomatic medial knee OA were included. Radiographic severity was graded by (1) Kellgren & Lawrence (KL) scale (Grade 2, n = 49; Grade, n = 52; Grade 4, n = 63) and; (2) medial tibiofemoral joint space narrowing (JSN) (Grade 1, n = 47; Grade 2, n = 50; Grade 3, n = 67). KAM-related parameters (peak KAM, KAM impulse and cumulative load) were determined from three-dimensional gait analysis and pedometry. Cumulative load was determined by multiplying KAM impulse by the average number of steps/day recorded over at least 5 days. Symptoms were assessed via numeric rating scale ((NRS), pain) and Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index (pain and physical function). Relationships between KAM parameters (independent variables) and symptoms (dependent variables) were evaluated by radiographic severity using linear models, adjusting for covariates. Results In mild disease (either KL Grade 2 or JSN Grade 1), there were no associations between KAM and symptoms. In moderate disease of KL Grade 3, higher KAM impulse was associated with greater WOMAC pain. In severe disease (KL Grade 4), higher KAM impulse was associated with less WOMAC pain (KL Grade 4), while higher peak KAM was associated with better function (KL Grade 4). Higher cumulative knee adduction load was associated with less pain on both NRS and WOMAC (JSN Grade 3) as well as better function (both JSN Grade 3 and KL Grade 4). Conclusions Relationships between KAM-related parameters and symptoms differ according to underlying radiographic OA severity.

Objective To investigate whether simultaneous telephone coaching improves the clinical effectiveness of a physiotherapist-prescribed home-based physical activity program for knee osteoarthritis (OA). Methods A total of 168 inactive adults ages ≥50 years with knee pain on a numeric rating scale ≥4 (NRS; range 0–10) and knee OA were recruited from the community and randomly assigned to a physiotherapy (PT) and coaching group (n = 84) or PT-only (n = 84) group. All participants received five 30-minute consultations with a physiotherapist over 6 months for education, home exercise, and physical activity advice. PT+coaching participants also received 6–12 telephone coaching sessions by clinicians trained in behavioral-change support for exercise and physical activity. Primary outcomes were pain (NRS) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC; score range 0–68]) at 6 months. Secondary outcomes were these same measures at 12 and 18 months, as well as physical activity, exercise adherence, other pain and function measures, and quality of life. Analyses were intent-to-treat with multiple imputation for missing data. Results A total of 142 (85%), 136 (81%), and 128 (76%) participants completed 6-, 12-, and 18-month measurements, respectively. The change in NRS pain (mean difference 0.4 unit [95% confidence interval (95% CI) −0.4, 1.3]) and in WOMAC function (1.8 [95% CI −1.9, 5.5]) did not differ between groups at 6 months, with both groups showing clinically relevant improvements. Some secondary outcomes related to physical activity and exercise behavior favored PT+coaching at 6 months but generally not at 12 or 18 months. There were no between-group differences in most other outcomes. Conclusion The addition of simultaneous telephone coaching did not augment the pain and function benefits of a physiotherapist-prescribed home-based physical activity program.

IntroductionChronic low back pain (CLBP) is the leading cause of disability worldwide. However, there is no consensus in the literature regarding optimal management. Exercise intervention is the most widely used treatment as it likely influences contributing factors such as physical and psychological. Literature evaluating the effects of exercise on CLBP is often generalised, non-specific and employs inconsistent outcome measures. Moreover, the mechanisms behind exercise-related improvements are poorly understood. Recently, research has emerged identifying associations between neuromuscular-biomechanical impairments and CLBP-related disability. This information can be used as the basis for more specific and, potentially more efficacious exercise interventions for CLBP patients.Methods and analysisNinety-four participants (including both males and females) with CLBP aged 18–65 who present for treatment to a Melbourne-based private physiotherapy practice will be recruited and randomised into one of two treatment groups. Following baseline assessment, participants will be randomly allocated to receive either: (i) strengthening exercises in combination with lumbar force accuracy training exercises or (ii) strengthening exercises alone. Participants will attend exercise sessions twice a week for 12 weeks, with assessments conducted at baseline, midway (ie, 6 weeks into the trial) and at trial completion. All exercise interventions will be supervised by a qualified physiotherapist trained in the intervention protocol. The primary outcome will be functional disability measured using the Oswestry Disability Index. Other psychosocial and mechanistic parameters will also be measured.Ethics and disseminationThis study was given approval by the University of Melbourne Behavioural and Social Sciences Human Ethics Sub-Committee on 8 August 2017, reference number 1 749 845. Results of the randomised controlled trial will be published in peer-reviewed journals.Trial registration numberACTRN12618000894291.