Associations between static foot posture, dynamic in-shoe plantar foot forces and knee pain in people with medial knee osteoarthritis: A cross-sectional exploratory study.

OBJECTIVE: To investigate relationships between static foot posture, dynamic plantar foot forces and knee pain in people with medial knee osteoarthritis (OA). DESIGN: Data from 164 participants with symptomatic, moderate to severe radiographic medial knee OA were analysed. Knee pain was self-reported using a numerical rating scale (NRS; scores 0-10; higher scores worse) and the Knee Injury and Osteoarthritis Outcome Score pain subscale (KOOS; scores 0-100; lower scores worse). Static foot posture was assessed using clinical tests (foot posture index, foot mobility magnitude, navicular drop). Dynamic plantar foot forces (lateral, medial, whole foot, medial-lateral ratio, arch index) were measured using an in-shoe plantar pressure system while walking. Relationships between foot posture and plantar forces (independent variables) and pain (dependent variables) were evaluated using linear regression models, unadjusted and adjusted for sex, walking speed, Kellgren & Lawrence grade, shoe category, and body mass (for dynamic plantar foot forces). RESULTS: No measure of static foot posture was associated with any knee pain measure. Higher medial-lateral foot force ratio at midstance, and a higher arch index during overall stance, were weakly associated with higher knee pain on the NRS (regression coefficient = 0.69, 95% confidence interval (CI) 0.09 to 1.28) and KOOS (coefficient=3.03, 95% CI 0.71 to 5.35) pain scales, respectively. CONCLUSION: Dynamic plantar foot forces, but not static foot posture, were associated with knee pain in people with medial knee OA. However, the amount of pain explained by increases in plantar foot force was small; thus, these associations are unlikely to be clinically meaningful.

Exploring experiences of people with knee osteoarthritis who received a physiotherapist-delivered dietary weight loss and exercise intervention: a mixed methods study.

OBJECTIVE: Explore the experiences of people with knee osteoarthritis who received a very low energy diet (VLED) and exercise program from a physiotherapist. METHODS: Mixed methods study involving questionnaires (n=42) and semi-structured interviews (n=22) with randomized control trial participants with knee osteoarthritis who had received a 6-month physiotherapist-delivered VLED weight loss and exercise intervention. Questionnaires measured participant satisfaction, and perceptions about physiotherapist's skills/knowledge in delivery of the dietary intervention (measured on 5-7 point Likert scales). Interviews explored participant's experiences and were analysed based on the principles of reflexive thematic analysis. RESULTS: Questionnaire response: 90%. Participants were satisfied with the program (95%), confident their physiotherapist had the required skills (84%) and knowledge (79%) to deliver the dietary intervention, felt comfortable talking to the physiotherapist about weight (74%), and would recommend others see a physiotherapist for the intervention they undertook (71%). Four themes were developed from the interviews: 1) one-stop-shop of exercise and diet; 2) physiotherapist-delivered weight loss works (unsure initially; successfully lost weight); 3) physiotherapists knowledge and skills (exercise is forte; most thought physiotherapists had the necessary weight loss skills/knowledge, but some disagreed); 4) physiotherapists have a role in weight loss (physiotherapists are intelligent, credible, and trustworthy; specific training in weight loss necessary). CONCLUSION: This study provides, to our knowledge, the first documented perspectives from people with osteoarthritis who have received a physiotherapist-delivered weight loss intervention. Findings suggest physiotherapists may have a role in delivering a protocolised dietary intervention for some people with knee osteoarthritis with overweight and obesity.

Telerehabilitation consultations with a physiotherapist for chronic knee pain versus in-person consultations in Australia: the PEAK non-inferiority randomised controlled trial.

BACKGROUND: Telerehabilitation whether perceived as less effective than in-person care for musculoskeletal problems. We aimed to determine if physiotherapy video conferencing consultations were non-inferior to in-person consultations for chronic knee pain. METHODS: In this non-inferiority randomised controlled trial, we recruited primary care physiotherapists from 27 Australian clinics. Using computer-generated blocks, participants with chronic knee pain consistent with osteoarthritis were randomly assigned (1:1, stratified by physiotherapist and clinic) in-person or telerehabilitation (ie, video conferencing) physiotherapist consultations. Participants and physiotherapists were unmasked to group assignment. Both groups had five consultations over 3 months for strengthening, physical activity, and education. Primary outcomes were knee pain (on a numerical rating scale of 0-10) and physical function (using the Western Ontario and McMaster Universities osteoarthritis index of 0-68) at 3 months after randomisation. Primary analysis was by modified intention-to-treat using all available data. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12619001240134. FINDINGS: Between Dec 10, 2019, and June 17, 2022, 394 adults were enrolled, with 204 allocated to in-person care and 190 to telerehabilitation. 15 primary care physiotherapists were recruited. At 3 months, 383 (97%) participants provided information for primary outcomes and both groups reported improved pain (mean change 2·98, SD 2·23 for in-person care and 3·14, 1·87 for telerehabilitation) and function (10·20, 11·63 and 10·75, 9·62, respectively). Telerehabilitation was non-inferior for pain (mean difference 0·16, 95% CI -0·26 to 0·57) and function (1·65, -0·23 to 3·53). The number of participants reporting adverse events was similar between groups (40 [21%] for in-person care and 35 [19%] for telerehabilitation) and none were serious. INTERPRETATION: Telerehabilitation with a physiotherapist is non-inferior to in-person care for chronic knee pain. FUNDING: National Health and Medical Research Council.

Lessons learnt from a nationally funded training and mentoring programme for early-mid career musculoskeletal researchers in Australia.

INTRODUCTION: Quality training and mentoring are crucial components of successful career development for early mid career researchers (EMCRs). This paper describes the overarching framework of novel ongoing national Training and Mentoring Programme Melbourne University Sydney Queensland:Impact (MUSQ:Impact) for musculoskeletal researchers, including a description of how it was set up and established, and lessons learned from its implementation. RESULTS: The MUSQ:Impact programme spans four multidisciplinary musculoskeletal research teams across three universities in Australia, comprising 40-60 EMCR members. It was established to provide EMCRs with a unique learning environment and opportunities to gain exposure to, and network with, other national musculoskeletal research teams. Specific goals are to focus on core research competencies (e.g. writing skills, managing grant budgets, public speaking and media engagement, research translation), provide career mentoring, fund development activities (e.g. conference attendance, laboratory visits, skill development courses), and share training resources (e.g. data dictionaries, project summaries). A Steering Committee of 10-12 EMCR members, co-chaired by a senior researcher and one EMCR, is responsible for overseeing MUSQ:Impact and organising regular activities, including a monthly webinar series, a mentor/mentee scheme, annual group research retreats, annual infographic competition, and funding awards. An evaluation survey found that most participants perceived each activity to be beneficial and of value to their research career and development. CONCLUSION: This paper presents the structure of national training and mentoring programme that serves as a potential template for other research teams to adapt within their own contexts.

Technical issues occur but are infrequent and have little impact on physiotherapist-delivered videoconferencing consultations for knee osteoarthritis: A descriptive study.

INTRODUCTION: Clinicians often report technical issues as a barrier to adopting videoconferencing service models. This descriptive study nested within a randomised controlled trial investigated the frequency, nature and impact of technical issues during video consultations. METHODS: Physiotherapists (n = 15) underwent training to deliver knee osteoarthritis care focussed on education, strengthening and physical activity. In the randomised controlled trial, participants received five physiotherapy consultations either in-person or via videoconferencing (via Zoom) over 3-months; consultations were recorded and physiotherapists documented technical difficulties. In this study, available notes were audited (n = 169 initial and n = 147 final consultations) and nature and frequency of technical issues coded. Based on whether the clinician reported technical difficulties, three subgroups were created for analysis 1) in-person, 2) videoconferencing without technical issues, 3) videoconferencing with technical issues. Forty participants were randomly selected for each subgroup (n = 120). Duration of consultation components (set-up and introduction, assessment, exercise, physical activity, education and wrap-up), total consultation duration and duration of technical issues were compared across subgroups using one-way multivariate analyses of variance with mean differences (MD) and 95% confidence intervals (CIs). RESULTS: Technical issues were documented in 37% (initial) and 19% (final) of video consultations. Problems with audio/video were most frequent, occurring in 36-21% (initial) and 18-24% (final) consultations. Audio/video problems were predominantly experienced during set-up, but did not significantly increase videoconferencing consultation duration compared to in-person consultation duration (MD (95% CI) 0.72 (-3.57 to 5.01) minutes). DISCUSSION: While technical issues with videoconferencing consultations frequently occur, they are typically minor, transient and resolved quickly.

Shoes for self-managing chronic hip Pain: the SCHIPP randomized clinical trial protocol.

BACKGROUND: Chronic hip pain is common and disabling and is largely due to osteoarthritis (OA). Self-management is recommended by international OA clinical guidelines yet there are few effective treatment options. Footwear has been suggested as a self-management approach, given that foot motion influences hip forces. Currently, guidelines advocate 'stable supportive' shoes for people with OA, however this is based solely on expert opinion given no research has investigated whether these shoes are effective at reducing symptoms in people with OA-related chronic hip pain. Therefore, this randomized controlled trial (RCT) aims to determine if stable supportive footwear reduces hip pain during walking compared to flat flexible footwear in people with chronic hip pain consistent with OA. METHODS: This trial is a 6-month, participant- and assessor-blinded, pragmatic, comparative effectiveness, superiority RCT conducted in Melbourne, Australia. We are recruiting 120 participants aged over 45 years with chronic hip pain consistent with OA from the community. Following baseline assessment, participants are randomized to receive either i) stable supportive shoes or ii) flat flexible shoes. Participants are permitted to choose two different pairs of shoes in their allocated group from a range of options that match prespecified shoe classification criteria. They are advised to wear either pair of study shoes daily for a minimum of 6 hours each day for 6 months. The primary outcome is the 6-month change in average hip pain on walking in the last week. Secondary outcomes include changes in other measures of hip pain, symptoms, function in daily living and sports and recreation, hip-related quality of life, pain at other sites, adverse events, and physical activity. Other measures include co-intervention use, adherence, shoe comfort, descriptive characteristics, footwear characteristics, and objective foot measures. DISCUSSION: This RCT will determine whether stable supportive shoes reduce hip pain during walking more than flat flexible shoes in people with chronic hip pain. Outcomes will help to inform footwear recommendations in international clinical guidelines for OA-related chronic hip pain, which to date have been based solely on expert opinion because of an absence of RCTs. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12621001532897.

Effect of motion control versus neutral walking footwear on pain associated with lateral tibiofemoral joint osteoarthritis: a comparative effectiveness randomised clinical trial.

OBJECTIVES: To determine if motion control walking shoes are superior to neutral walking shoes in reducing knee pain on walking in people with lateral knee osteoarthritis (OA). DESIGN: Participant-blinded and assessor-blinded, comparative effectiveness, superiority randomised controlled trial. SETTING: Melbourne, Australia. PARTICIPANTS: People with symptomatic radiographic lateral tibiofemoral OA from the community and our volunteer database. INTERVENTION: Participants were randomised to receive either motion control or neutral shoes and advised to wear them >6 hours/day over 6 months. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was change in average knee pain on walking over the previous week (11-point Numeric Rating Scale (NRS), 0-10) at 6 months. The secondary outcomes included other measures of knee pain, physical function, quality of life, participant-perceived change in pain and function, and physical activity. RESULTS: We planned to recruit 110 participants (55 per arm) but ceased recruitment at 40 (n=18 motion control shoes, n=22 neutral shoes) due to COVID-19-related impacts. All 40 participants completed 6-month outcomes. There was no evidence that motion control shoes were superior to neutral shoes for the primary outcome of pain (mean between-group difference 0.4 NRS units, 95% CI -1.0 to 1.7) nor for any secondary outcome. The number of participants experiencing any adverse events was similar between groups (motion control shoes: n=5, 28%; neutral shoes: n=4, 18.2%) and were minor. CONCLUSIONS: Motion control shoes were not superior to neutral shoes in improving knee pain on walking in symptomatic radiographic lateral tibiofemoral joint OA. Further research is needed to identify effective treatments in this important but under-researched knee OA subgroup. TRIAL REGISTRATION NUMBER: ACTRN12618001864213.

Exercise adherence Mobile app for Knee Osteoarthritis: protocol for the MappKO randomised controlled trial.

BACKGROUND: In people with knee osteoarthritis (OA), ongoing exercise participation, particularly with strengthening exercises, is central to management. Patient adherence to prescribed exercise typically declines once consultations with a clinician have ceased. Mobile applications (apps) can incorporate behaviour change techniques that may assist adherence, potentially optimising clinical outcomes. METHODS: This is a two-arm, pragmatic, superiority randomised trial. One hundred and eighty two Australians with chronic knee pain (clinical knee OA) and who have at least a mild level of physical dysfunction are being recruited. Participants are randomly allocated i) exercise (physiotherapist-prescribed exercise) or; ii) exercise plus app (physiotherapist-prescribed exercise plus access to the 'My Exercise Messages' mobile app). Exercise care comprises two videoconferencing consultations with a physiotherapist over two weeks (30 min each) for a strengthening exercise program, which is then conducted independently at home for 24 weeks without any further physiotherapist consultations. Participants are also provided with exercise resources to facilitate home-based exercise. Those randomised to exercise plus app will download the app after completing the two weeks of physiotherapy consultations and will be instructed by research staff to use the app for the 24 weeks of unsupervised home-based exercises. The app works by tracking completion of weekly exercise sessions, providing regular messages to facilitate weekly exercise and providing personalised messages to help overcome individual barriers to exercise participation. The two primary outcomes are i) self-reported physical function; and ii) number of days strengthening exercises were performed (previous fortnight), with a primary endpoint of 26 weeks and a secondary endpoint of 14 weeks. Secondary outcomes include knee pain severity; knee-related quality of life; global change; exercise program satisfaction; exercise self-efficacy; physical activity; sport and recreation function; another measure of exercise adherence; and willingness to undergo joint replacement. Process measures are also included. DISCUSSION: Findings will determine if a theory-informed mobile app improves exercise adherence and physical function in people with knee OA who have received a home-based strengthening program. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12621000724875. Prospectively registered 9/06/2021.

A comparison of psychological characteristics in people with knee osteoarthritis from Japan and Australia: A cross-sectional study.

The aim of this study was to investigate differences in psychological characteristics between people with knee osteoarthritis (OA) from Japan and Australia. Sixty-two adults from Japan and 168 adults from Australia aged over 50 years with knee pain were included. Japanese data were collected from patients with knee OA diagnosed by medical doctors. Australian data were baseline data from a randomized controlled trial. Participants were not exercising regularly or receiving physiotherapy at the time. Psychological characteristics evaluated were depressive symptoms, fear of movement, and pain catastrophizing. These psychological characteristics were compared between the Japanese and Australian cohorts by calculating 95% confidence intervals (CIs) for difference of the mean. To test for equivalence, an equivalence margin was set at 0.5 standard deviations (SD) of the mean, where these SDs were based on the Australian data. When the 95%CI for the difference of the mean value lay entirely within the range of equivalence margin (i.e. between -0.5 and 0.5 times the Australian SD), the outcome was considered equivalent. There were no differences between the groups from Japan and Australia for depressive symptoms and the two groups were considered equivalent. There was no difference between groups for fear of movement, however the criteria for equivalence was not met. People from Japan with knee OA had higher scores for pain catastrophizing than people from Australia. The findings should be confirmed in other samples of people with knee OA from Japan and Australia due to the limitations of the participant recruitment strategy in this study. However, our findings suggest there may be a greater need to consider pain catastrophizing and build pain self-efficacy when managing Japanese people with knee OA. Implementation of international clinical practice guidelines for OA management may require different strategies in different countries due to different psychological profiles.

Expert-Moderated Peer-to-Peer Online Support Group for People With Knee Osteoarthritis: Mixed Methods Randomized Controlled Pilot and Feasibility Study.

BACKGROUND: Osteoarthritis (OA) is a major problem globally. First-line management comprises education and self-management strategies. Online support groups may be a low-cost method of facilitating self-management. OBJECTIVE: The aim of this randomized controlled pilot study is to evaluate the feasibility of the study design and implementation of an evidence-informed, expert-moderated, peer-to-peer online support group (My Knee Community) for people with knee OA. The impacts on psychological determinants of self-management, selected self-management behaviors, and health outcomes were secondary investigations. METHODS: This mixed methods study evaluated study feasibility (participant recruitment, retention, and costs), experimental intervention feasibility (acceptability and fidelity to the proposed design, including perceived benefit, satisfaction, and member engagement), psychological determinants (eg, self-efficacy and social support), behavioral measures, health outcomes, and harms. Of a total of 186, 63 (33.9%) participants (41/63, 65% experimental and 22/63, 35% control) with self-reported knee OA were recruited from 186 volunteers. Experimental group participants were provided membership to My Knee Community, which already had existing nonstudy members, and were recommended a web-based education resource (My Joint Pain). The control group received the My Joint Pain website recommendation only. Participants were not blinded to their group allocation or the study interventions. Participant-reported data were collected remotely using web-based questionnaires. A total of 10 experimental group participants also participated in semistructured interviews. The transcribed interview data and all forum posts by the study participants were thematically analyzed. RESULTS: Study feasibility was supported by acceptable levels of retention; however, there were low levels of engagement with the support group by participants: 15% (6/41) of participants did not log in at all; the median number of times visited was 4 times per participant; only 29% (12/41) of participants posted, and there were relatively low levels of activity overall on the forum. This affected the results for satisfaction (overall mean 5.9/10, SD 2.7) and perceived benefit (17/31, 55%: yes). There were no differences among groups for quantitative outcomes. The themes discussed in the interviews were connections and support, information and advice, and barriers and facilitators. Qualitative data suggest that there is potential for people to derive benefit from connecting with others with knee OA by receiving support and assisting with unmet informational needs. CONCLUSIONS: Although a large-scale study is feasible, the intervention implementation was considered unsatisfactory because of low levels of activity and engagement by members. We recommend that expectations about the support group need to be made clear from the outset. Additionally, the platform design needs to be more engaging and rewarding, and membership should only be offered to people willing to share their personal stories and who are interested in learning from the experiences of others. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001230145; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377958.

An e-Learning Program for Physiotherapists to Manage Knee Osteoarthritis Via Telehealth During the COVID-19 Pandemic: Real-World Evaluation Study Using Registration and Survey Data.

BACKGROUND: The COVID-19 pandemic necessitated clinicians to transition to telehealth, often with little preparation or training. The Physiotherapy Exercise and Physical Activity for Knee Osteoarthritis (PEAK) e-learning modules were developed to upskill physiotherapists in management of knee osteoarthritis (OA) via telehealth and in-person. In the research setting, the e-learning modules are perceived by physiotherapists as effective when they are part of a comprehensive training program for a clinical trial. However, the effectiveness of the modules on their own in a real-world setting is unknown. OBJECTIVE: This study aims to evaluate the reach, effectiveness, adoption, and implementation of PEAK e-learning modules. METHODS: This longitudinal study was informed by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Participants were clinicians, researchers, educators, and health care students who registered for access to the modules between April 1 and November 30, 2020. Reach was evaluated by outcomes (countries, referral sources, and attrition) extracted from registration data and embedded within precourse surveys in the Learning Management System (LMS). Effectiveness was evaluated by outcomes (confidence with videoconferencing; likelihood of using education, strengthening exercise, and physical activity in a treatment plan for knee OA; usefulness of modules) measured using a 10-point numeric rating scale (NRS; score range from 1=not confident or likely or useful at all to 10=extremely confident or likely or useful) in pre- and postcourse (on completion) surveys in the LMS. Adoption and implementation were evaluated by demographic and professional characteristics and outcomes related to the use of learning and usefulness of program elements (measured via a 4-point Likert scale, from not at all useful to extremely useful) in a survey administered 4 months after module completion. RESULTS: Broad reach was achieved, with 6720 people from 97 countries registering for access. Among registrants, there were high levels of attrition, with 36.65% (2463/6720) commencing the program and precourse survey and 19.61% (1318/6720) completing all modules and the postcourse survey. The program was effective. Learners who completed the modules demonstrated increased confidence with videoconferencing (mean change 3.1, 95% CI 3.0-3.3 NRS units) and increased likelihood of using education, strengthening and physical activity in a knee OA treatment plan, compared to precourse. Adoption and implementation of learning (n=149 respondents) occurred at 4 months. More than half of the respondents used their learning to structure in-person consultations with patients (80/142, 56.3%) and patient information booklets in their clinical practice (75/142, 52.8%). CONCLUSIONS: Findings provide evidence of the reach and effectiveness of an asynchronous self-directed e-learning program in a real-world setting among physiotherapists. The e-learning modules offer clinicians an accessible educational course to learn about best-practice knee OA management, including telehealth delivery via videoconferencing. Attrition across the e-learning program highlights the challenges of keeping learners engaged in self-directed web-based learning.

Evaluation of a Novel e-Learning Program for Physiotherapists to Manage Knee Osteoarthritis via Telehealth: Qualitative Study Nested in the PEAK (Physiotherapy Exercise and Physical Activity for Knee Osteoarthritis) Randomized Controlled Trial.

BACKGROUND: The delivery of physiotherapy via telehealth could provide more equitable access to services for patients. Videoconference-based telehealth has been shown to be an effective and acceptable mode of service delivery for exercise-based interventions for chronic knee pain; however, specific training in telehealth is required for physiotherapists to effectively and consistently deliver care using telehealth. The development and evaluation of training programs to upskill health care professionals in the management of osteoarthritis (OA) has also been identified as an important priority to improve OA care delivery. OBJECTIVE: This study aims to explore physiotherapists' experiences with and perceptions of an e-learning program about best practice knee OA management (focused on a structured program of education, exercise, and physical activity) that includes telehealth delivery via videoconferencing. METHODS: We conducted a qualitative study using individual semistructured telephone interviews, nested within the Physiotherapy Exercise and Physical Activity for Knee Osteoarthritis randomized controlled trial, referred to as the PEAK trial. A total of 15 Australian physiotherapists from metropolitan and regional private practices were interviewed following the completion of an e-learning program. The PEAK trial e-learning program involved self-directed learning modules, a mock video consultation with a researcher (simulated patient), and 4 audited practice video consultations with pilot patients with chronic knee pain. Interviews were audio recorded and transcribed verbatim. Data were thematically analyzed. RESULTS: A total of five themes (with associated subthemes) were identified: the experience of self-directed e-learning (physiotherapists were more familiar with in-person learning; however, they valued the comprehensive, self-paced web-based modules. Unwieldy technological features could be frustrating); practice makes perfect (physiotherapists benefited from the mock consultation with the researcher and practice sessions with pilot patients alongside individualized performance feedback, resulting in confidence and preparedness to implement new skills); the telehealth journey (although inexperienced with telehealth before training, physiotherapists were confident and able to deliver remote care following training; however, they still experienced some technological challenges); the whole package (the combination of self-directed learning modules, mock consultation, and practice consultations with pilot patients was felt to be an effective learning approach, and patient information booklets supported the training package); and impact on broader clinical practice (training consolidated and refined existing OA management skills and enabled a switch to telehealth when the COVID-19 pandemic affected in-person clinical care). CONCLUSIONS: Findings provide evidence for the perceived effectiveness and acceptability of an e-learning program to train physiotherapists (in the context of a clinical trial) on best practice knee OA management, including telehealth delivery via videoconferencing. The implementation of e-learning programs to upskill physiotherapists in telehealth appears to be warranted, given the increasing adoption of telehealth service models for the delivery of clinical care.

Association Between Therapeutic Alliance and Outcomes Following Telephone-Delivered Exercise by a Physical Therapist for People With Knee Osteoarthritis: Secondary Analyses From a Randomized Controlled Trial.

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.

The Effect of Flat Flexible Versus Stable Supportive Shoes on Knee Osteoarthritis Symptoms : A Randomized Trial.

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.

Podiatry Intervention Versus Usual General Practitioner Care for Symptomatic Radiographic Osteoarthritis of the First Metatarsophalangeal Joint: A Randomized Clinical Feasibility Study.

OBJECTIVE: To determine the feasibility of a clinical trial comparing a podiatry intervention to usual general practitioner (GP) care for people with first metatarsophalangeal (MTP) joint osteoarthritis (OA). METHODS: A 2-arm, participant- and assessor-blinded, randomized feasibility study was conducted over 12 weeks. Participants were age >40 years and had pain and radiographic OA in the first MTP joint. Participants in the podiatry group had 3 visits and received foot orthoses, exercise, manual therapy, and advice. Participants in the GP group had 1 visit and received medication advice/prescription and the same advice as the podiatry group. Primary outcomes were measures of feasibility (recruitment, attendance, and retention rates; percentage of prescribed exercise sessions completed; orthoses wear hours/day; treatment fidelity). Secondary outcomes included self-reported pain, function, satisfaction, adherence, adverse events, and dropouts. RESULTS: A total of 236 people were screened, and 30 (13%) were included. All except 1 participant in the podiatry group attended the required clinical visits, and retention rates were 93% (podiatry group) and 80% (GP group). Participants completed 66% of the exercise sessions and wore orthoses for an average of 6.3 hours/day. Adherence to medication use was 5.3 on an 11-point numeric rating scale. Both treatment approaches improved pain and function by clinically important differences at 12 weeks. CONCLUSION: A clinical trial comparing a podiatry intervention to usual GP care for people with first MTP joint OA is feasible. Given the improvements in pain and function observed, a larger appropriately powered clinical trial is warranted to evaluate the superiority of one treatment approach over the other.

Technology versus tradition: a non-inferiority trial comparing video to face-to-face consultations with a physiotherapist for people with knee osteoarthritis. Protocol for the PEAK randomised controlled 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.

The association between psychological characteristics and physical activity levels in people with knee osteoarthritis: a cross-sectional analysis.

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.

Footwear for osteoarthritis of the lateral knee: protocol for the FOLK randomised controlled trial.

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).

Therapeutic Alliance Between Physical Therapists and Patients With Knee Osteoarthritis Consulting Via Telephone: A Longitudinal Study.

OBJECTIVE: To explore therapeutic alliance between physical therapists and patients with knee osteoarthritis during telephone consultations. Specifically, to describe and compare physical therapist and patient ratings, to determine whether alliance changes over time, and to evaluate whether individual characteristics are associated with alliance. METHODS: We performed a secondary analysis of 84 patients in the intervention arm of a randomized controlled trial who completed 5-10 consultations with 1 of 8 physical therapists via telephone over 26 weeks, involving education, advice, and prescription of a strengthening and physical activity program. Therapeutic alliance was measured after the second (week 4) and final consultations (week 26), using the Working Alliance Inventory-Short Form. RESULTS: Patient and physical therapist ratings of the alliance were high. At week 4, patients rated the overall alliance, and all 3 subscales, higher than therapists. At 26 weeks, patients rated the Task subscale higher than therapists. Patient ratings for the Goal subscale decreased over time, while physical therapist ratings for total alliance and the Bond subscale increased. For patients, the variables of living with others, consulting with a therapist with no previous experience delivering care remotely, having more telephone consultations, and having a higher self-efficacy were associated with greater alliance ratings. Therapists were more likely to perceive a stronger alliance if they had less clinical experience and when treating patients who were younger and had higher self-efficacy. CONCLUSION: Physical therapist perceptions of the therapeutic alliance tended to be lower than those of patients early in treatment, but differences were small and of unclear clinical significance. Some subgroups of patients rated the alliance more strongly than others.

Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial.

OBJECTIVE: Evaluate a physiotherapist-led telephone-delivered exercise advice and support intervention for people with knee osteoarthritis. METHODS: Participant-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. RESULTS: 165 (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. CONCLUSION: Telephone-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 NUMBER: Australian New Zealand Clinical Trials Registry (#12616000054415).