Physiotherapy - Research Publications

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    A self-directed digital exercise program for hip osteoarthritis ("My Hip Exercise"): protocol for a randomised controlled trial
    Bennell, KL ; Nelligan, RK ; Hall, M ; Stratulate, S ; McManus, F ; Lamb, K ; Marlow, J ; Hinman, RS (BMC, 2023-11-21)
    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).
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    Effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program for hip osteoarthritis - protocol for the Better Hip randomised controlled trial
    Bennell, KL ; Keating, C ; Lawford, B ; Graham, B ; Hall, M ; Simpson, JA ; McManus, F ; Hosking, B ; Sumithran, P ; Harris, A ; Woode, ME ; Francis, JJ ; Marlow, J ; Poh, S ; Hinman, RS (BMC, 2024-02-13)
    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).
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    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
    Lawford, BJ ; Bennell, KL ; Hall, M ; Egerton, T ; Filbay, S ; Mcmanus, F ; Lamb, KE ; Hinman, RS (J O S P T, 2023-04)
    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.
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    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
    Lawford, BJ ; Hinman, RS ; McManus, F ; Lamb, KE ; Egerton, T ; Keating, C ; Brown, C ; Oliver, K ; Bennell, KL (WILEY, 2023-11)
    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.
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    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
    Lawford, BJ ; Bennell, KL ; Hall, M ; Egerton, T ; McManus, F ; Lamb, KE ; Hinman, RS (WILEY, 2023-01-01)
    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.
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    Effectiveness of an Unsupervised Online Yoga Program on Pain and Function in People With Knee Osteoarthritis A Randomized Clinical Trial
    Bennell, KL ; Schwartz, S ; Teo, PL ; Hawkins, S ; Mackenzie, D ; McManus, F ; Lamb, KE ; Kimp, AJ ; Metcalf, B ; Hunter, DJ ; Hinman, RS (AMER COLL PHYSICIANS, 2022-10)
    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.
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    Effect of foot orthoses vs sham insoles on first metatarsophalangeal joint osteoarthritis symptoms: a randomized controlled trial
    Paterson, KL ; Hinman, RS ; Metcalf, BR ; McManus, F ; Jones, SE ; Menz, HB ; Munteanu, SE ; Bennell, KL (ELSEVIER SCI LTD, 2022-06)
    OBJECTIVES: To compare contoured foot orthoses to sham flat insoles for first MTP joint OA walking pain. DESIGN: This was a participant- and assessor-blinded, sham-controlled, multi-centre randomized clinical trial set in community-based private practices. Eighty-eight adults aged ≥45 years with symptomatic radiographic first MTP joint OA were randomized to receive contoured foot orthoses (n = 47) or sham flat insoles (n = 41), worn at all times when wearing shoes for 12 weeks. Primary outcome was change in first MTP joint walking pain (11-point numerical rating scale (NRS), 0-10) over 12 weeks. Secondary outcomes included additional first MTP joint and foot pain measures, physical function, quality of life and physical activity. Separate linear regression models for primary and secondary outcomes on treatment group were fit, adjusting for the outcome at baseline and podiatrist. Other measures included adverse events. RESULTS: 88 participants were randomized and 87 (99%) completed the 12-week primary outcome. There was no evidence foot orthoses were superior to sham insoles for reducing pain (mean difference -0.3 NRS units (95% CI -1.2 to 0.6), p = 0.53). Similarly, foot orthoses were not superior to sham on any secondary outcomes. Sensitivity analyses yielded similar results. Adverse events were generally minor and transient. CONCLUSION: Contoured foot orthoses are no more effective than flat sham insoles for the clinical management of first MTP joint OA. Given the dearth of evidence on treatments for first MTP joint OA, further research is needed to identify effective management approaches for this common and debilitating condition.
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    Comparative effect of two educational videos on self-efficacy and kinesiophobia in people with knee osteoarthritis: an online randomised controlled trial
    Egerton, T ; Bennell, KL ; McManus, F ; Lamb, KE ; Hinman, RS (ELSEVIER SCI LTD, 2022-10)
    OBJECTIVE: To compare change in self-efficacy for managing knee osteoarthritis (OA) pain and kinesiophobia after watching an educational video based on an empowerment and participatory discourse with a video based on a disease and impairment discourse. DESIGN: Two-arm randomised controlled trial with participants aged ≥45 years with knee pain (n = 589). Participants completed both baseline and follow-up outcomes and watched one randomly-allocated video (12-minute duration) during one 30-45-minute session within a single online survey. The experimental video presented evidence-based knee OA information using design and language that aimed to empower people and focus on activity participation to manage OA, while the control video presented similar information but with a disease and impairment focus. Primary outcome measures were Arthritis Self-Efficacy Scale pain subscale (range 0-10) and Brief Fear of Movement Scale for OA (range 6-24). Secondary outcomes were expectations about prognosis and physical activity benefits, perceived importance and motivation to be physically active, knee OA knowledge, hopefulness for the future, level of concern and perceived need for surgery. RESULTS: Compared to control (n = 293), the experimental group (n = 296) showed improved self-efficacy for managing OA pain (mean difference 0.4 [95%CI 0.2, 0.6] units) and reduced kinesiophobia (1.6 [1.1, 2.0] units). The experimental group also demonstrated greater improvements in all secondary outcomes apart from hopefulness, which was high in both groups. CONCLUSION: An educational video based on an empowerment and participatory discourse improved pain self-efficacy and reduced kinesiophobia in people with knee OA more than a video based on a disease and impairment discourse. CLINICALTRIALS: gov registration NCT05156216, Universal trial number U1111-1269-6143.
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    Shoes for self-managing chronic hip Pain: the SCHIPP randomized clinical trial protocol
    Paterson, KLL ; Bennell, KLL ; Metcalf, BRR ; Jones, SEE ; Campbell, PKK ; McManus, F ; Lamb, KEE ; Hinman, RSS (BMC, 2023-02-23)
    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.
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    Exercise adherence Mobile app for Knee Osteoarthritis: protocol for the MappKO randomised controlled trial
    Hinman, RS ; Nelligan, RK ; Campbell, PK ; Kimp, AJ ; Graham, B ; Merolli, M ; McManus, F ; Lamb, KE ; Bennell, KL (BMC, 2022-09-20)
    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.