Effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program for hip osteoarthritis - protocol for the Better Hip randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of chronic pain and disability worldwide. Self-management is vital with education, exercise and weight loss core recommended treatments. However, evidence-practice gaps exist, and service models that increase patient accessibility to clinicians who can support lifestyle management are needed. The primary aim of this study is to determine the effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip) on the primary outcomes of hip pain on walking and physical function at 6 months, compared with an information-only control for people with hip OA. METHODS: A two-arm, parallel-design, superiority pragmatic randomised controlled trial. 212 members from a health insurance fund aged 45 years and over, with painful hip OA will be recruited. Participants will be randomly allocated to receive: i) Better Hip; or ii) web-based information only (control). Participants randomised to the Better Hip program will have six videoconferencing physiotherapist consultations for education about OA, prescription of individualised home-based strengthening and physical activity programs, behaviour change support, and facilitation of other self-management strategies. Those with a body mass index > 27 kg/m2, aged < 80 years and no specific health conditions, will also be offered six videoconferencing dietitian consultations to undertake a weight loss program. Participants in the control group will be provided with similar educational information about managing hip OA via a custom website. All participants will be reassessed at 6 and 12 months. Primary outcomes are hip pain on walking and physical function. Secondary outcomes include measures of pain; hip function; weight; health-related quality of life; physical activity levels; global change in hip problem; willingness to undergo hip replacement surgery; rates of hip replacement; and use of oral pain medications. A health economic evaluation at 12 months will be conducted and reported separately. DISCUSSION: Findings will determine whether a telehealth-delivered clinician-supported lifestyle management program including education, exercise/physical activity and, for those with overweight or obesity, weight loss, is more effective than information only in people with hip OA. Results will inform the implementation of such programs to increase access to core recommended treatments. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN12622000461796).

A self-directed digital exercise program for hip osteoarthritis ("My Hip Exercise"): protocol for a randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading global cause of chronic pain and disability. Given there is no cure for OA, patient self management is vital with education and exercise being core recommended treatments. However, there is under-utilisation of these treatments due to a range of clinician and patient factors. Innovative service models that increase patient accessibility to such treatments and provide support to engage are needed. This study primarily aims to determine the effects of a self-directed digital exercise intervention comprising online education and exercise supported by a mobile app to facilitate adherence on the primary outcomes of changes in hip pain during walking and patient-reported physical function at 24-weeks when compared to online education control for people with hip OA. METHODS: We will conduct a two-arm, superiority parallel-design, randomised controlled trial involving 182 community volunteers aged 45 years and over, with painful hip OA. After completing the baseline assessment, participants will be randomly assigned to either: i) digital exercise intervention; or ii) digital education (control). Participants randomised to the intervention group will have access to a website that provides information about hip OA and its management, advice about increasing their physical activity levels, a 24-week lower limb strength exercise program to be undertaken at home three times per week, and a mobile app to reinforce home exercise program adherence. Participants in the control group will have access to a website containing only information about hip OA and its management. All participants will be reassessed at 24 weeks after randomisation. Primary outcomes are severity of hip pain while walking using an 11-point numeric rating scale and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index subscale. Secondary outcomes are the Hip dysfunction and Osteoarthritis Outcome Score subscales of pain, hip-related quality of life, and function, sports and recreational activities; global change in hip condition; health-related quality of life; measures of physical activity levels; fear of movement; self efficacy for pain and for exercise; and use of oral pain medications. DISCUSSION: Innovative and scalable approaches to OA education, physical activity, and exercise are required in order to improve exercise participation/engagement and mitigate physical inactivity in the hip OA population. This will help minimise the burden of this major public health issue on individuals and society. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN12622001533785).

Effects of Hip Pain Diagnostic Labels and Their Explanations on Beliefs About Hip Pain and How to Manage It: An Online Randomized Controlled Trial.

OBJECTIVES: To compare the effects of diagnostic labels and their explanations on people's beliefs about managing hip pain. DESIGN: Online randomized controlled trial involving 626 participants. METHODS: Participants aged ≥45 years with and without hip pain considered a hypothetical scenario (initial doctor consultation for hip pain). They were randomized to receive a diagnostic label and explanation of (1) hip osteoarthritis, (2) persistent hip pain, or (3) hip degeneration. Primary outcomes were the beliefs (1) exercise would damage the hip and (2) surgery is necessary at some stage (scales, 0 = definitely would not/unnecessary, 10 = definitely would/necessary). Secondary outcomes included beliefs about other treatments and care providers. RESULTS: Compared to hip degeneration, participants who were allocated to hip osteoarthritis and persistent hip pain believed exercise was less damaging (mean difference -1.3 [95% CI: -1.9, -0.7] and -1.8 [-2.3, -1.2], respectively) and surgery less necessary (-1.5 [-2.1, -1.0] and -2.2 [-2.7, -1.6], respectively). Compared to hip osteoarthritis, participants who were allocated to persistent hip pain believed surgery was less necessary (-0.7 [-1.2, -0.1]), but not that exercise was less damaging (-0.5 [-1.1, 0.1]). Compared to hip degeneration, participants who were allocated to hip osteoarthritis and persistent hip pain were less concerned about their hip and believed exercise and care from an exercise and sports physician, rheumatologist, or physiotherapist would be more helpful, and care from an orthopaedic surgeon less helpful. CONCLUSIONS: People who were allocated a diagnostic label and explanation of hip osteoarthritis or persistent hip pain believed exercise was less damaging and surgery less necessary for a hip problem than hip degeneration. J Orthop Sports Phys Ther 2023;53(11):673-684. Epub 5 October 2023. doi:10.2519/jospt.2023.11984.

How Does Exercise, With and Without Diet, Improve Pain and Function in Knee Osteoarthritis? A Secondary Analysis of a Randomized Controlled Trial Exploring Potential Mediators of Effects.

OBJECTIVE: To explore the mediators of effects of two 6-month telehealth-delivered exercise programs, including exercise with and without weight-loss diet, on pain and function improvements in knee osteoarthritis (OA). METHODS: Secondary analysis of 345 participants from a 3-arm randomized controlled trial of exercise (Exercise program) and exercise plus diet (Diet + Exercise program) versus information (Control program) was conducted. Outcomes were changes in pain (11-point numeric rating scale) and function (Western Ontario and McMaster Universities Osteoarthritis Index [score range 0-68]) at 12 months. Potential mediators were change at 6 months in attitudes toward self-management, fear of movement, arthritis self-efficacy, weight, physical activity, and willingness for knee surgery. For the Diet + Exercise program versus the Exercise program, only change in weight was evaluated. RESULTS: Possible mediators of the Exercise program versus the Control program included reduced fear of movement (accounting for -1.11 units [95% confidence interval (95% CI) -2.15, -0.07] improvement in function) and increased arthritis self-efficacy (-0.40 units [95% CI -0.75, -0.06] reduction in pain, -1.66 units [95% CI -3.04, -0.28] improvement in function). The Diet + Exercise program versus the Control program mediators included reduced fear of movement (-1.13 units [95% CI -2.17, -0.08] improvement in function), increased arthritis self-efficacy (-0.77 units [95% CI -1.26, -0.28] reduction in pain, -5.15 units [95% CI -7.34, -2.96] improvement in function), and weight loss (-1.20 units [95% CI -1.73, -0.68] reduction in pain, -5.79 units [95% CI -7.96, -3.63] improvement in function). Weight loss mediated the Diet + Exercise program versus the Exercise program (-0.89 units [95% CI -1.31, -0.47] reduction in pain, -4.02 units [95% CI -5.77, -2.26] improvement in function). CONCLUSION: Increased arthritis self-efficacy, reduced fear of movement, and weight loss may partially mediate telehealth-delivered exercise program effects, with and without diet, on pain and/or function in knee OA. Weight loss may partially mediate the effect of diet and exercise compared to exercise alone.

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.

Removing Pathoanatomical Content From Information Pamphlets About Knee Osteoarthritis Did Not Affect Beliefs About Imaging or Surgery, but Led to Lower Perceptions That Exercise Is Damaging and Better Osteoarthritis Knowledge: An Online Randomised Controlled Trial.

OBJECTIVE: Compare the effects of osteoarthritis information, with or without pathoanatomical content, on people's beliefs about managing osteoarthritis. DESIGN: Online randomized controlled trial involving 556 participants. METHODS: Participants considered a hypothetical scenario where their doctor informed them that they had knee osteoarthritis. Participants were randomized to a control condition, where they received currently available osteoarthritis information with pathoanatomical content or an experimental condition, where they received the same osteoarthritis information but without pathoanatomical content. Primary outcomes were participants' beliefs about the need for x-ray to confirm diagnosis and joint replacement surgery in the future. RESULTS: There were no between-group differences in primary outcomes for x-ray (mean difference [MD], -0.3; 95% confidence interval [CI]: -0.9, 0.4) and surgery (MD, -0.2; 95% CI: -0.7, 0.2), each rated on an 11-point numeric rating scale. Participants in the experimental group had lower perceptions that exercise would damage the knee (MD, -0.4; 95% CI: -0.8, 0.0; rated on an 11-point numeric rating scale) and better osteoarthritis knowledge (MD, 0.9; 95% CI: 0.0, 1.9; rated on a scale ranging from 11 to 55). Among those without tertiary education, participants in the experimental group had lower perceptions that x-ray was necessary than control (MD, -0.8; 95% CI: -1.5, -0.1). Among those who had never sought care for knee pain, participants in the experimental group had lower perceptions about the need for surgery (MD, -0.7; 95% CI: -1.2, -0.2). CONCLUSIONS: Removing pathoanatomical content may not change beliefs about imaging and surgery but may lead to lower perceptions that exercise is damaging and may improve osteoarthritis knowledge. However, effects were small and of unclear clinical relevance. Tertiary education or a history of care seeking for knee pain may moderate effects on primary outcomes. J Orthop Sports Phys Ther 2023;53(4):1-15. Epub: 12 December 2022. doi:10.2519/jospt.2022.11618.

Effect of Information Content and General Practitioner Recommendation to Exercise on Treatment Beliefs and Intentions for Knee Osteoarthritis: An Online Multi-Arm Randomized Controlled Trial.

OBJECTIVE: To evaluate effects of general osteoarthritis (OA) information in addition to a treatment option grid and general practitioner (GP) recommendation to exercise on treatment beliefs and intentions. METHODS: An online randomized trial of 735 people 45 years old or older without OA who were recruited from a consumer survey network. Participants read a hypothetical scenario about visiting their GP for knee problems and were randomized to the following: i) 'general information', ii) 'option grid' (general information plus option grid), or iii) 'option grid plus recommendation' (general information plus option grid plus GP exercise recommendation). The primary outcome was an agreement that exercise is the best management option (0-10 numeric rating scale; higher scores indicating higher agreement that exercise is best). The secondary outcomes were beliefs about other management options and management intentions. Linear regression models estimated the mean (95% confidence interval [CI]) between-group difference in postintervention scores, adjusted for baseline. RESULTS: Option grid plus recommendation led to higher agreement that exercise is the best management by a mean of 0.4 units (95% CI: 0.1-0.6) compared with general information. There were no other between-group differences for the primary outcome. Option grid led to higher agreement that surgery was best, and x-rays were necessary, compared with general information (mean between-group differences: 0.7 [CI: 0.2-1.1] and 0.5 [CI: 0.1-1.0], respectively) and option grid plus recommendation (0.5 [CI: 0.1-0.9] and 0.9 [CI: 0.4-1.3]). CONCLUSION: Addition of an option grid and GP exercise recommendation to general OA information led to more favorable views that exercise was best for the hypothetical knee problem. However, differences were small and of unclear clinical importance.

Clinician-administered performance-based tests via telehealth in people with chronic lower limb musculoskeletal disorders: Test-retest reliability and agreement with in-person assessment.

INTRODUCTION: Uptake of telehealth has surged, yet no previous studies have evaluated the clinimetric properties of clinician-administered performance-based tests of function, strength, and balance via telehealth in people with chronic lower limb musculoskeletal pain. This study investigated the: (i) test-retest reliability of performance-based tests via telehealth, and (ii) agreement between scores obtained via telehealth and in-person. METHODS: Fifty-seven adults aged ≥45 years with chronic lower limb musculoskeletal pain underwent three testing sessions: one in-person and two via videoconferencing. Tests included 30-s chair stand, 5-m fast-paced walk, stair climb, timed up and go, step test, timed single-leg stance, and calf raises. Test-retest reliability and agreement were assessed via intraclass correlation coefficients (ICC; lower limit of 95% confidence interval (CI) ≥0.70 considered acceptable). ICCs were interpreted as poor (<0.5), moderate (0.5-0.75), good (0.75-0.9), or excellent (>0.9). RESULTS: Test-retest reliability was good-excellent with acceptable lower CI for stair climb test, timed up and go, right leg timed single-leg stance, and calf raises (ICC = 0.84-0.91, 95% CI lower limit = 0.71-0.79). Agreement between telehealth and in-person was good-excellent with acceptable lower CI for 30-s chair stand, left leg single-leg stance, and calf raises (ICC = 0.82-0.91, 95% CI lower limit = 0.71-0.85). DISCUSSION: Stair climb, timed up and go, right leg timed single-leg stance, and calf raise tests have acceptable reliability for use via telehealth in research and clinical practice. If re-testing via a different mode (telehealth/in-person), clinicians and researchers should consider using the 30-s chair stand test, left leg timed single-leg stance, and calf raise tests.

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.

Effectiveness of an Unsupervised Online Yoga Program on Pain and Function in People With Knee Osteoarthritis : A Randomized Clinical Trial.

BACKGROUND: Yoga is a mind-body exercise typically done in groups in person, but this delivery method can be inconvenient, inaccessible, and costly. Effective online programs may increase access to exercise for knee osteoarthritis. OBJECTIVE: To evaluate the effectiveness of an unsupervised 12-week online yoga program. DESIGN: Two-group superiority randomized trial. (Australian New Zealand Clinical Trials Registry: ACTRN12620000012976). SETTING: Community. PARTICIPANTS: 212 adults with symptomatic knee osteoarthritis. INTERVENTION: Both groups received online osteoarthritis information (control). The yoga group also received access to an unsupervised online yoga program delivered via prerecorded videos over 12 weeks (1 video per week, with each session to be performed 3 times per week), with optional continuation thereafter. MEASUREMENTS: Primary outcomes were changes in knee pain during walking (0 to 10 on a numerical rating scale) and physical function (0 to 68 on the Western Ontario and McMaster Universities Osteoarthritis Index) at 12 weeks (primary time point) and 24 weeks, analyzed using mixed-effects linear regression models. Secondary outcomes were self-reported overall knee pain, stiffness, depression, anxiety, stress, global change, quality of life, self-efficacy, fear of movement, and balance confidence. Adverse events were also collected. RESULTS: A total of 195 (92%) and 189 (89%) participants provided 12- and 24-week primary outcomes, respectively. Compared with control at 12 weeks, yoga improved function (between-group mean difference in change, -4.0 [95% CI, -6.8 to -1.3]) but not knee pain during walking (between-group mean difference in change, -0.6 [CI, -1.2 to 0.1]), with more yoga participants than control participants achieving the minimal clinically important difference (MCID) for both outcomes. At 12 weeks, knee stiffness, quality of life, and arthritis self-efficacy improved more with yoga than the control intervention. Benefits were not maintained at 24 weeks. Adverse events were minor. LIMITATION: Participants were unblinded. CONCLUSION: Compared with online education, an unsupervised online yoga program improved physical function but not knee pain at 12 weeks in people with knee osteoarthritis, although the improvement did not reach the MCID and was not sustained at 24 weeks. PRIMARY FUNDING SOURCE: National Health and Medical Research Council and Centres of Research Excellence.

Effectiveness of a telehealth physiotherapist-delivered intensive dietary weight loss program combined with exercise in people with knee osteoarthritis and overweight or obesity: study protocol for the POWER randomized controlled trial.

BACKGROUND: Obesity is associated with knee osteoarthritis (OA). Weight loss, alongside exercise, is a recommended treatment for individuals with knee OA and overweight/obesity. However, many patients cannot access weight loss specialists such as dietitians. Innovative care models expanding roles of other clinicians may increase access to weight loss support for people with knee OA. Physiotherapists may be well placed to deliver such support. This two-group parallel, superiority randomized controlled trial aims to compare a physiotherapist-delivered diet and exercise program to an exercise program alone, over 6 months. The primary hypothesis is that the physiotherapist-delivered diet plus exercise program will lead to greater weight loss than the exercise program. METHODS: 88 participants with painful knee OA and body mass index (BMI) > 27 kg/m2 will be recruited from the community. Following baseline assessment, participants will be randomised to either exercise alone or diet plus exercise groups. Participants in the exercise group will have 6 consultations (20-30 min) via videoconference with a physiotherapist over 6 months for a strengthening exercise program, physical activity plan and educational/exercise resources. Participants in the diet plus exercise group will have 6 consultations (50-75 min) via videoconference with a physiotherapist prescribing a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating, plus the intervention of the exercise only group. Outcomes are measured at baseline and 6 months. The primary outcome is percentage change in body weight measured by a blinded assessor. Secondary outcomes include self-reported knee pain, physical function, global change in knee problems, quality of life, physical activity levels, and internalised weight stigma, as well as BMI, waist circumference, waist-to-hip ratio, physical performance measures and quadriceps strength, measured by a blinded assessor. Additional measures include adherence, adverse events, fidelity and process measures. DISCUSSION: This trial will determine whether a physiotherapist-delivered diet plus exercise program is more effective for weight loss than an exercise only program. Findings will inform the development and implementation of innovative health service models addressing weight management and exercise for patients with knee OA and overweight/obesity. TRIAL REGISTRATION: NIH US National Library of Medicine, Clinicaltrials.gov NCT04733053 (Feb 1 2021).

Effects of adding aerobic physical activity to strengthening exercise on hip osteoarthritis symptoms: protocol for the PHOENIX randomised controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Most evidence is based on muscle-strengthening exercise, but aerobic physical activity has potential to enhance clinical benefits. The primary aim of this study is to test the hypothesis that adding aerobic physical activity to a muscle strengthening exercise leads to significantly greater reduction in hip pain and improvements in physical function, compared to a lower-limb muscle strengthening exercise program alone at 3 months. METHODS: This is a superiority, 2-group, parallel randomised controlled trial including 196 people with symptomatic hip OA from the community. Following baseline assessment, participants are randomly allocated to receive either i) aerobic physical activity and muscle strengthening exercise or; ii) muscle strengthening exercise only. Participants in both groups receive 9 consultations with a physiotherapist over 3 months. Both groups receive a progressive muscle strengthening exercise program in addition to advice about OA management. The aerobic physical activity plan includes a prescription of moderate intensity aerobic physical activity with a goal of attaining 150 min per week. Primary outcomes are self-reported hip pain assessed on an 11-point numeric rating scale (0 = 'no pain' and 10 = 'worst pain possible') and self-reported physical function (Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale) at 3 months. Secondary outcomes include other measures of self-reported pain (assessed at 0, 3, 9 months), self-reported physical function (assessed at 0, 3, 9 months), performance-based physical function (assessed at 0, 3 months), joint stiffness (assessed at 0, 3, 9 months), quality of life (assessed at 0, 3, 9 months), muscle strength (assessed at 0, 3 months), and cardiorespiratory fitness (assessed at 0, 3 months). Other measures include adverse events, co-interventions, and adherence. Measures of body composition, serum inflammatory biomarkers, quantitative sensory measures, anxiety, depression, fear of movement and self-efficacy are included to explore causal mechanisms. DISCUSSION: Findings will assist to provide an evidence-based recommendation regarding the additional effect of aerobic physical activity to lower-limb muscle strengthening on hip OA pain and physical function. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN 12619001297112. Registered 20th September 2019.

Effects of adding a diet intervention to exercise on hip osteoarthritis pain: protocol for the ECHO randomized controlled trial.

BACKGROUND: Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Despite some clinical guidelines also recommending weight loss for hip OA, there is no evidence from randomised controlled trials (RCT) to substantiate these recommendations. This superiority, 2-group, parallel RCT will compare a combined diet and exercise program to an exercise only program, over 6 months. METHODS: One hundred people with symptomatic and radiographic hip OA will be recruited from the community. Following baseline assessment, participants will be randomly allocated to either, i) diet and exercise or; ii) exercise only. Participants in the diet and exercise group will have six consultations with a dietitian and five consultations with a physiotherapist via videoconferencing over 6 months. The exercise only group will have five consultations with a physiotherapist via videoconferencing over 6 months. The exercise program for both groups will include prescription of strengthening exercise and a physical activity plan, advice about OA management and additional educational resources. The diet intervention includes prescription of a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating. Primary outcome is self-reported hip pain via an 11-point numeric rating scale (0 = 'no pain' and 10 = 'worst pain possible') at 6 months. Secondary outcomes include self-reported body weight (at 0, 6 and 12 months) and body mass index (at 0, 6 and 12 months), visceral fat (measured using dual energy x-ray absorptiometry at 0 and 6 months), pain, physical function, quality of life (all measured using subscales of the Hip Osteoarthritis Outcome Scale at 0, 6 and 12 months), and change in pain and physical activity (measured using 7-point global rating of change Likert scale at 6 and 12 months). Additional measures include adherence, adverse events and cost-effectiveness. DISCUSSION: This study will determine whether a diet intervention in addition to exercise provides greater hip pain-relief, compared to exercise alone. Findings will assist clinicians in providing evidence-based advice regarding the effect of a dietary intervention on hip OA pain. TRIAL REGISTRATION: ClinicalTrials.gov . Identifier: NCT04825483 . Registered 31st March 2021.

Moderators of the Effect of a Self-directed Digitally Delivered Exercise Program for People With Knee Osteoarthritis: Exploratory Analysis of a Randomized Controlled Trial.

BACKGROUND: A 24-week self-directed digitally delivered intervention was found to improve pain and function in people with knee osteoarthritis (OA). However, it is possible that this intervention may be better suited to certain subgroups of people with knee OA compared to others. OBJECTIVE: The aim of this study was to explore whether certain individual baseline characteristics moderate the effects of a self-directed digitally delivered intervention on changes in pain and function over 24 weeks in people with knee OA. METHODS: An exploratory analysis was conducted on data from a randomized controlled trial involving 206 people with a clinical diagnosis of knee OA. This trial compared a self-directed digitally delivered intervention comprising of web-based education, exercise, and physical activity program supported by automated exercise behavior change mobile phone text messages to web-based education alone (control). The primary outcomes were changes in overall knee pain (assessed on an 11-point numerical rating scale) and physical function (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale [WOMAC]) at 24 weeks. Five baseline patient characteristics were selected as the potential moderators: (1) number of comorbidities, (2) number of other painful joints, (3) pain self-efficacy, (4) exercise self-efficacy, and (5) self-perceived importance of exercise. Separate linear regression models for each primary outcome and each potential moderator were fit, including treatment group, moderator, and interaction between treatment group and moderator, adjusting for the outcome at baseline. RESULTS: There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction P=.02). Posthoc assessment of the mean change in WOMAC function by treatment arm showed that each 1-unit increase in baseline pain self-efficacy was associated with a 1.52 (95% CI 0.27 to 2.78) unit improvement in the control group. In contrast, a reduction of 0.62 (95% CI -1.93 to 0.68) units was observed in the intervention group with each unit increase in pain self-efficacy. There was only weak evidence that pain self-efficacy moderated the effect of the intervention on pain and that number of comorbidities, number of other painful joints, exercise self-efficacy, or exercise importance moderated the effect of the intervention on pain or function. CONCLUSIONS: With the exception of pain self-efficacy, which moderated changes in function but not pain, we found limited evidence that our selected baseline patient characteristics moderated intervention outcomes. This indicates that people with a range of baseline characteristics respond similarly to the unsupervised digitally delivered exercise intervention. As these findings are exploratory in nature, they require confirmation in future studies.

Evidence-based management of patients with vertigo, dizziness, and imbalance at an Australian metropolitan health service: an observational study of clinical practice.

AIM: To determine whether patients presenting to the emergency department (ED) with possible benign paroxysmal positional vertigo (BPPV) are managed in accordance with best practice guidelines, and whether physiotherapists are involved in their care. DESIGN: Retrospective observational study. PARTICIPANTS: Ninety-six consecutive patients presenting to one of three EDs with vertigo, dizziness or imbalance symptoms documented at triage. Individuals with a clear non-vestibular cause of symptoms were excluded. OUTCOME MEASURES: Proportional adherence to clinical practice guidelines by medical and physiotherapy clinicians, primary diagnosis, incidence of falls, admission to hospital, and referral to a physiotherapy service. RESULTS: Adherence to clinical practice guidelines by both professions was low, with only 25 (26%, 95% CI: 18-36%) and 3 (14%, 95% CI: 4-36%) patients assessed by a medical clinician or physiotherapist, respectively, receiving the gold-standard Dix-Hallpike test. Sixty-four (67%) individuals were given a diagnosis of undifferentiated dizziness. Of the 26 (27%) patients with a primary BPPV diagnosis, only three (12%) were treated with a canalith-repositioning technique, and four (15%) reviewed by a physiotherapist. CONCLUSION: Adherence to best-practice guidelines for the management of BPPV in individuals presenting to the ED is low, and physiotherapists are seldom involved in their management.

Effect of physical therapy on pain and function in patients with hip osteoarthritis: a randomized clinical trial.

IMPORTANCE: There is limited evidence supporting use of physical therapy for hip osteoarthritis. OBJECTIVE: To determine efficacy of physical therapy on pain and physical function in patients with hip osteoarthritis. DESIGN, SETTING, AND PARTICIPANTS: Randomized, placebo-controlled, participant- and assessor-blinded trial involving 102 community volunteers with hip pain levels of 40 or higher on a visual analog scale of 100 mm (range, 0-100 mm; 100 indicates worst pain possible) and hip osteoarthritis confirmed by radiograph. Forty-nine patients in the active group and 53 in the sham group underwent 12 weeks of intervention and 24 weeks of follow-up (May 2010-February 2013) INTERVENTIONS: Participants attended 10 treatment sessions over 12 weeks. Active treatment included education and advice, manual therapy, home exercise, and gait aid if appropriate. Sham treatment included inactive ultrasound and inert gel. For 24 weeks after treatment, the active group continued unsupervised home exercise while the sham group self-applied gel 3 times weekly. MAIN OUTCOMES AND MEASURES: Primary outcomes were average pain (0 mm, no pain; 100 mm, worst pain possible) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 no difficulty to 68 extreme difficulty) at week 13. Secondary outcomes were these measures at week 36 and impairments, physical performance, global change, psychological status, and quality of life at weeks 13 and 36. RESULTS: Ninety-six patients (94%) completed week 13 measurements and 83 (81%) completed week 36 measurements. The between-group differences for improvements in pain were not significant. For the active group, the baseline mean (SD) visual analog scale score was 58.8 mm (13.3) and the week-13 score was 40.1 mm (24.6); for the sham group, the baseline score was 58.0 mm (11.6) and the week-13 score was 35.2 mm (21.4). The mean difference was 6.9 mm favoring sham treatment (95% CI, -3.9 to 17.7). The function scores were not significantly different between groups. The baseline mean (SD) physical function score for the active group was 32.3 (9.2) and the week-13 score was 27.5 (12.9) units, whereas the baseline score for the sham treatment group was 32.4 (8.4) units and the week-13 score was 26.4 (11.3) units, for a mean difference of 1.4 units favoring sham (95% CI, -3.8 to 6.5) at week 13. There were no between-group differences in secondary outcomes (except greater week-13 improvement in the balance step test in the active group). Nineteen of 46 patients (41%) in the active group reported 26 mild adverse effects and 7 of 49 (14%) in the sham group reported 9 mild adverse events (P = .003). CONCLUSIONS AND RELEVANCE: Among adults with painful hip osteoarthritis, physical therapy did not result in greater improvement in pain or function compared with sham treatment, raising questions about its value for these patients. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12610000439044.

Efficacy of a multimodal physiotherapy treatment program for hip osteoarthritis: a randomised placebo-controlled trial protocol.

BACKGROUND: Hip osteoarthritis (OA) is a common condition leading to pain, disability and reduced quality of life. There is currently limited evidence to support the use of conservative, non-pharmacological treatments for hip OA. Exercise and manual therapy have both shown promise and are typically used together by physiotherapists to manage painful hip OA. The aim of this randomised controlled trial is to compare the efficacy of a physiotherapy treatment program with placebo treatment in reducing pain and improving physical function. METHODS: The trial will be conducted at the University of Melbourne Centre for Health, Exercise and Sports Medicine. 128 participants with hip pain greater or equal to 40/100 on visual analogue scale (VAS) and evidence of OA on x-ray will be recruited. Treatment will be provided by eight community physiotherapists in the Melbourne metropolitan region. The active physiotherapy treatment will comprise a semi-structured program of manual therapy and exercise plus education and advice. The placebo treatment will consist of sham ultrasound and the application of non-therapeutic gel. The participants and the study assessor will be blinded to the treatment allocation. Primary outcomes will be pain measured by VAS and physical function recorded on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) immediately after the 12 week intervention. Participants will also be followed up at 36 weeks post baseline. CONCLUSIONS: The trial design has important strengths of reproducibility and reflecting contemporary physiotherapy practice. The findings from this randomised trial will provide evidence for the efficacy of a physiotherapy program for painful hip OA.

Hip muscle weakness in individuals with medial knee osteoarthritis.

OBJECTIVE: To compare the strength of the hip musculature in people with symptomatic medial knee osteoarthritis (OA) with asymptomatic controls. METHODS: Eighty-nine people with knee OA and 23 controls age >50 years were recruited from the community. The maximal isometric strength (torque relative to body mass) of the hip abductors, adductors, flexors, extensors, and internal and external rotators was evaluated using hand-held dynamometry or a customized force transducer apparatus. Univariate linear models with age and sex included as covariates were used to compare muscle strength between groups. RESULTS: In people with knee OA, significant strength deficits were evident for all hip muscle groups evaluated (P < 0.05). Compared with controls, strength deficits ranged from 16% (hip extensors) to 27% (hip external rotators) after accounting for differences in sex and age between groups. CONCLUSION: People with knee OA demonstrate significant weakness of the hip musculature compared with asymptomatic controls. It is not clear if hip muscle weakness precedes the onset of knee OA or occurs as a consequence of disease. Findings from this study support the inclusion of hip strengthening exercises in rehabilitation programs.

Predictors of single-leg standing balance in individuals with medial knee osteoarthritis.

OBJECTIVE: To identify factors related to single-leg standing balance in individuals with medial compartment knee osteoarthritis (OA). METHODS: This cross-sectional study assessed clinical, demographic, and biomechanical measures in 57 individuals and their relationships with single-leg standing balance. Differences in age, mass, symptoms, knee pain, radiographic severity, lower extremity alignment, and hip and knee extension as well as hip abduction torques were compared between those who could and could not perform 3 trials of single-leg standing balance. Multiple regression was used to identify predictors of center of pressure (COP) path length in those who could complete the task. RESULTS: Thirty-four individuals (60%) successfully completed all 3 single-leg standing balance trials and were significantly younger (P = 0.003) than those who could not. No other variable was significantly different between the groups. Disease severity, number of painful knees, lower extremity alignment, pain intensity, and quadriceps torque were all significant predictors of COP path length. Specifically, better single-leg standing balance (smaller COP path length) was related to more severe radiographic changes and stronger quadriceps, those with bilateral symptoms, and to less varus malalignment and knee pain. CONCLUSION: Single-leg standing balance in those with medial knee OA is related to the modifiable factors lower extremity alignment, knee pain, and quadriceps strength. Given the reduced balancing ability in this patient population, interventions targeting these factors are necessary.