Alternative models to support weight loss in chronic musculoskeletal conditions: effectiveness of a physiotherapist-delivered intensive diet programme for knee osteoarthritis, the POWER randomised controlled trial.

OBJECTIVES: To determine if physiotherapists can deliver a clinically effective very low energy diet (VLED) supplementary to exercise in people with knee osteoarthritis (OA) and overweight or obesity. METHODS: 88 participants with knee OA and body mass index (BMI) >27 kg/m2 were randomised to either intervention (n=42: VLED including two daily meal replacement products supplementary to control) or control (n=46: exercise). Both interventions were delivered by unblinded physiotherapists via six videoconference sessions over 6 months. The primary outcome was the percentage change in body weight at 6 months, measured by a blinded assessor. Secondary outcomes included BMI, waist circumference, waist-to-hip ratio, self-reported measures of pain, function, satisfaction and perceived global change, and physical performance tests. RESULTS: The intervention group lost a mean (SD) of 8.1% (5.2) body weight compared with 1.0% (3.2) in the control group (mean (95% CI) between-group difference 7.2% (95% CI 5.1 to 9.3), p<0.001), with significantly lower BMI and waist circumference compared with control group at follow-up. 76% of participants in the intervention group achieved ≥5% body weight loss and 37% acheived ≥10%, compared with 12% and 0%, respectively, in the control group. More participants in the intervention group (27/38 (71.1%)) reported global knee improvement than in the control group (20/42 (47.6%)) (p=0.02). There were no between-group differences in any other secondary outcomes. No serious adverse events were reported. CONCLUSION: A VLED delivered by physiotherapists achieved clinically relevant weight loss and was safe for people with knee OA who were overweight or obese. The results have potential implications for future service models of care for OA and obesity. TRIAL REGISTRATION NUMBER: NIH, US National Library of Medicine, Clinicaltrials.gov NCT04733053 (1 February 2021).

Exploring the potential extended role of community pharmacy in the management of osteoarthritis: A multi-methods study with pharmacy staff and other healthcare professionals.

INTRODUCTION: Osteoarthritis is the commonest form of chronic joint pain, which patients often self-manage before seeking healthcare advice. Patients frequently seek advice from community pharmacies, and a recent policy has recommended integrating community pharmacies into long-term condition pathways. This study explored community pharmacy teams' (CPs) and other healthcare professionals' (HCPs) views on community pharmacies providing an extended role for osteoarthritis management, identifying potential barriers and facilitators to this. METHODS: A multi-methods study comprising surveys of CPs and other HCPs, followed by qualitative interviews. Descriptive statistics were used in an exploratory analysis of the survey data. Qualitative data were analysed using reflexive thematic analysis and the identified barriers and facilitators were mapped to the Theoretical Domains Framework. RESULT: CPs and other HCPs in the surveys and interviews reported that an extended role for osteoarthritis management could include: a subjective assessment, explaining the joint problem and its treatment, medication management and support for self-care. There was less consensus on diagnosing the problem as OA and completing an objective assessment. A key facilitator was training to deliver the role, whilst barriers were high workload and lack of access to General Practitioner medical records. DISCUSSION: Acceptable elements of an extended community pharmacy role for osteoarthritis centre around the provision of information, advice on medication and supported self-management. CONCLUSION: CPs are well placed to contribute towards evidenced-based osteoarthritis management. Feasibility testing of delivering the extended role is needed and future implementation requires training for CPs and raising public awareness of the extended role.

Co-development and testing of an extended community pharmacy model of service delivery for managing osteoarthritis: protocol for a sequential, multi-methods study (PharmOA).

BACKGROUND: Osteoarthritis is a common, painful and disabling long-term condition. Delivery of high-quality guideline-informed osteoarthritis care that successfully promotes and maintains supported self-management is imperative. However, osteoarthritis care remains inconsistent, including under use of core non-pharmacological approaches of education, exercise and weight loss. Community pharmacies are an accessible healthcare provider. United Kingdom government initiatives are promoting their involvement in a range of long-term conditions, including musculoskeletal conditions. It is not known what an enhanced community pharmacy role for osteoarthritis care should include, what support is needed to deliver such a role, and whether it would be feasible and acceptable to community pharmacy teams. In this (PharmOA) study, we aim to address these gaps, and co-design and test an evidence-based extended community pharmacy model of service delivery for managing osteoarthritis. METHODS: Informed by the Theoretical Domains Framework, Normalisation Process Theory, and the Medical Research Council (MRC) framework for developing complex interventions, we will undertake a multi-methods study involving five phases: 1. Systematic review to summarise currently available evidence on community pharmacy roles in supporting adults with osteoarthritis and other chronic (non-cancer) pain. 2. Cross-sectional surveys and one-to-one qualitative interviews with patients, healthcare professionals and pharmacy staff to explore experiences of current, and potential extended community pharmacy roles, in delivering osteoarthritis care. 3. Stakeholder co-design to: a) agree on the extended role of community pharmacies in osteoarthritis care; b) develop a model of osteoarthritis care within which the extended roles could be delivered (PharmOA model of service delivery); and c) refine existing tools to support community pharmacies to deliver extended osteoarthritis care roles (PharmOA tools). 4. Feasibility study to explore the acceptability and feasibility of the PharmOA model of service delivery and PharmOA tools to community pharmacy teams. 5. Final stakeholder workshop to: a) finalise the PharmOA model of service delivery and PharmOA tools, and b) if applicable, prioritise recommendations for its wider future implementation. DISCUSSION: This novel study paves the way to improving access to and availability of high-quality guideline-informed, consistent care for people with osteoarthritis from within community pharmacies.

A new measure of exercise adherence: the ATEMPT (Adherence To Exercise for Musculoskeletal Pain Tool).

OBJECTIVES: This study aimed to (1) develop a new measure of adherence to exercise for musculoskeletal (MSK) pain (Adherence To Exercise for Musculoskeletal Pain Tool: ATEMPT) based on previously conceptualised domains of exercise adherence, (2) report the content and structural validity, internal consistency, test-retest reliability, and measurement error for the ATEMPT outcome measure in patients managed with exercise for MSK pain. METHODS: ATEMPT was created using statements describing adherence generated by patients, physiotherapists and researchers, with content validity established. Baseline and retest questionnaires were distributed to patients recommended exercise for MSK pain in 11 National Health Service physiotherapy clinics. Items demonstrating low response variation were removed and the following measurement properties assessed: structural validity, internal consistency, test-retest reliability and measurement error. RESULTS: Baseline and retest data were collected from 382 and 112 patients with MSK pain, respectively. Confirmatory factor analysis established that a single factor solution was the best fit according to Bayesian Information Criterion. The 6-item version of the measure (scored 6-30) demonstrated optimal internal consistency (Cronbach's Alpha 0.86, 95% CI 0.83 to 0.88) with acceptable levels of test-retest reliability (intraclass correlation coefficient 0.84, 95% CI 0.78 to 0.88) and measurement error (smallest detectable change 3.77, 95% CI 3.27 to 4.42) (SE of measurement 2.67, 95% CI 2.31 to 3.16). CONCLUSION: The 6-item ATEMPT was developed from the six domains of exercise adherence. It has adequate content and structural validity, internal consistency, test-retest reliability and measurement error in patients with MSK pain, but should undergo additional testing to establish the construct validity and responsiveness.

The cost-effectiveness of adding an ultrasound corticosteroid and local anaesthetic injection to advice and education for hip osteoarthritis.

OBJECTIVES: Evidence for the comparative cost-effectiveness of intra-articular corticosteroid injection in people with hip osteoarthritis (OA) remains unclear. This study investigated the cost-effectiveness of best current treatment (BCT) comprising advice and education plus a single ultrasound-guided intra-articular hip injection (USGI) of 40 mg triamcinolone acetonide and 4 ml 1% lidocaine hydrochloride (BCT+US-T) versus BCT alone. METHODS: A trial-based cost-utility analysis of BCT+US-T compared with BCT was undertaken over 6 months. Patient-level cost data were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a United Kingdom (UK) National Health Service (NHS) perspective. RESULTS: BCT+US-T was associated with lower mean NHS costs (BCT+US-T minus BCT: £-161.6, 95% CI: £-583.95 to £54.18) and small but significantly higher mean QALYs than BCT alone over 6 months (BCT+US-T minus BCT: 0.0487, 95% CI: 0.0091, 0.0886). In the base case, BCT+US-T was the most cost-effective and dominated BCT alone. Differences in total costs were driven by number of visits to NHS consultants, private physiotherapists, and chiropractors, and hip surgery, which were more common with BCT alone than BCT+US-T. CONCLUSION: Intra-articular corticosteroid injection plus BCT (BCT+US-T) for patients with hip OA results in lower costs and better outcomes, and is highly cost-effective, compared with BCT alone. TRIAL REGISTRATION: EudraCT: 2014-003412-37 (August 8, 2015) and registered with Current Controlled Trials: ISRCTN 50550256 (July 28, 2015). TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-018-2153-0#citeas. DOI: doi.org/10.1186/s12891-018-2153-0.

Mechanisms of action of therapeutic exercise for knee and hip OA remain a black box phenomenon: an individual patient data mediation study with the OA Trial Bank.

OBJECTIVES: To evaluate mediating factors for the effect of therapeutic exercise on pain and physical function in people with knee/hip osteoarthritis (OA). METHODS: For Subgrouping and TargetEd Exercise pRogrammes for knee and hip OsteoArthritis (STEER OA), individual participant data (IPD) were sought from all published randomised controlled trials (RCTs) comparing therapeutic exercise to non-exercise controls in people with knee/hip OA. Using the Counterfactual framework, the effect of the exercise intervention and the percentage mediated through each potential mediator (muscle strength, proprioception and range of motion (ROM)) for knee OA and muscle strength for hip OA were determined. RESULTS: Data from 12 of 31 RCTs of STEER OA (1407 participants) were available. Within the IPD data sets, there were generally statistically significant effects from therapeutic exercise for pain and physical function in comparison to non-exercise controls. Of all potential mediators, only the change in knee extension strength was statistically and significantly associated with the change in pain in knee OA (ß -0.03 (95% CI -0.05 to -0.01), 2.3% mediated) and with physical function in knee OA (ß -0.02 (95% CI -0.04 to -0.00), 2.0% mediated) and hip OA (ß -0.03 (95% CI -0.07 to -0.00), no mediation). CONCLUSIONS: This first IPD mediation analysis of this scale revealed that in people with knee OA, knee extension strength only mediated ±2% of the effect of therapeutic exercise on pain and physical function. ROM and proprioception did not mediate changes in outcomes, nor did knee extension strength in people with hip OA. As 98% of the effectiveness of therapeutic exercise compared with non-exercise controls remains unexplained, more needs to be done to understand the underlying mechanisms of actions.

Improving the Effectiveness of Exercise Therapy for Adults With Knee Osteoarthritis: A Pragmatic Randomized Controlled Trial (BEEP Trial).

Objective: To investigate whether knee osteoarthritis (OA) related pain and function can be improved by offering enhanced physical therapist-led exercise interventions. Design: Three-arm prospectively designed pragmatic randomized controlled trial. Setting: General practices and National Health Service physical therapy services in England. Participants: 514 adults (252 men, 262 women) aged ≥45 years with a clinical diagnosis of knee osteoarthritis (N=514). Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at baseline were 8.4 for pain and 28.1 for function. Interventions: Participants were individually randomized (1:1:1 allocation) to usual physical therapy care (UC control: up to 4 sessions of advice and exercise over 12 weeks), individually tailored exercise (ITE: individualized, supervised, and progressed lower limb exercises, 6-8 sessions over 12 weeks), or targeted exercise adherence (TEA: transitioning from lower limb exercise to general physical activity, 8-10 contacts over 6 months). Main Outcome Measures: Primary outcomes were pain and physical function measured by the WOMAC at 6 months. Secondary outcomes were measured at 3, 6, 9, 18, and 36 months. Results: Participants receiving UC, ITE, and TEA all experienced moderate improvement in pain and function. There were no significant differences between groups at 6 months (adjusted mean differences (95% confidence intervals): pain UC vs ITE, -0.3 (-1.0 to 0.4), UC vs TEA, -0.3 (-1.0 to 0.4); function UC vs ITE, 0.5 (-1.9 to 2.9), UC vs TEA, -0.9 (-3.3 to 1.5)), or any other time-point. Conclusions: Patients receiving UC experienced moderate improvement in pain and function; however, ITE and TEA did not lead to superior outcomes. Other strategies for patients with knee osteoarthritis to enhance the benefits of exercise-based physical therapy are needed.

Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis: study protocol for a feasibility randomised controlled trial.

BACKGROUND: Exercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be generalised to people aged 80 years or older. Rapid loss of muscle occurs after 70 years of age, and older people are more likely to also have other health conditions that contribute to difficulties with daily activities and impact on their response to exercise. To improve care for people aged 80 or older with osteoarthritis, it is thought that a tailored exercise intervention targeting both osteoarthritis and any other health conditions they have, may be needed. The aim of this study will be to test if it is possible to conduct a randomised controlled trial (RCT) for people over 80 years of age with hip/knee osteoarthritis of a tailored exercise intervention. METHODS: A multicentre, parallel, 2-group, feasibility RCT with embedded qualitative study, conducted in ≥ 3 UK NHS physiotherapy outpatient services. Participants (n ≥ 50) with clinical knee and/or hip osteoarthritis and ≥ 1 comorbidity will be recruited by screening referrals to participating NHS physiotherapy outpatient services, via screening of general practice records and via identification of eligible individuals from a cohort study run by our research group. Participants will be randomised (computer-generated: 1:1) to receive either: a 12-week education and tailored exercise intervention (TEMPO); or usual care and written information. The primary feasibility objectives are to estimate: (1) ability to screen and recruit eligible participants; (2) retention of participants, measured by the proportion of participants who provide outcome data at 14-week follow-up. Secondary quantitative objectives are to estimate: (1) participant engagement assessed by physiotherapy session attendance and home exercise adherence; (2) sample size calculation for a definitive RCT. One-to-one semi-structured interviews will explore the experiences of trial participants and physiotherapists delivering the TEMPO programme. DISCUSSION: Progression criteria will be used to determine whether a definitive trial to evaluate the clinical and cost-effectiveness of the TEMPO programme is considered feasible with or without modifications to the intervention or trial design. TRIAL REGISTRATION: ISRCTN75983430. Registered 3/12/2021. https://www.isrctn.com/ISRCTN75983430.

What should a toolkit to aid the delivery of therapeutic exercise for hip and knee osteoarthritis look like? Qualitative analysis of an international survey of 318 researchers, clinicians, and consumers by the OARSI Rehabilitation Discussion Group.

BACKGROUND: We aimed to identify important components of, and practical resources relevant for inclusion in, a toolkit to aid exercise delivery for people with hip/knee osteoarthritis. METHOD: An online international multi-disciplinary survey was conducted across 43 countries (139 clinicians, 44 people with hip/knee osteoarthritis and 135 osteoarthritis researchers). Participants were presented with the seeding statement 'Practical resources to aid the implementation of exercise for people with hip/knee osteoarthritis should…' and asked to provide up to 10 open text responses. Responses underwent refinement and qualitative content analysis to create domains and categories. RESULTS: Refinement of 551 open text responses yielded 72 unique statements relevant for analysis. Statements were organised into nine broad domains, suggesting that resources to aid exercise delivery should: (1) be easily accessible; (2) be of high quality; (3) be developed by, and for, stakeholders; (4) include different ways of delivering information; (5) include different types of resources to support exercise and non-exercise components of self-management; (6) include resources on recommended exercises and how to perform/progress them; (7) include tools to support motivation and track progress; (8) include resources to enable tailoring of the programme to the individual and; (9) facilitate access to professional and peer support. CONCLUSION: Our findings identified important components of, and practical resources to include within, a toolkit to aid delivery of exercise for people with hip/knee osteoarthritis. These findings have implications for exercise providers and lay the foundation for the development of a toolkit to help ensure exercise provision aligns with current international recommendations.

Conceptualising adherence to exercise for musculoskeletal pain: A concept mapping study.

BACKGROUND: The concept of adherence to exercise for musculoskeletal (MSK) pain is poorly defined and inadequately measured. This study aimed to, (1) conceptualise adherence to exercise therapy for MSK pain, and (2) identify statements most representative of the new conceptualisation that could be developed into items for a new measurement tool. METHODS: Concept mapping methodology was used, which is an integrated mixed methods approach. Focus groups with stakeholders generated statements describing adherence to exercise for MSK pain. Statements were grouped according to themes and rated for importance. Data analysis via multidimensional scaling and hierarchical cluster analysis produced a series of concept maps, which were refined during a further stakeholder workshop to produce the final conceptualisation of exercise adherence. Mean importance ratings established statements most suitable for future development. RESULTS: Twenty-eight participants produced 100 unique statements concerning adherence, which were sorted and rated. Analysis of the sort data with further participant refinement concluded that adherence to exercise consists of six domains: communication with experts; targets; how exercise is prescribed; patient knowledge and understanding; motivation and support; and psychological approach and attitudes. Fifty-six statements were rated with above average importance for inclusion in a new measure of adherence to exercise for MSK pain. CONCLUSION: Adherence to exercise for MSK pain is a complex and multi-dimensional construct represented by six distinct domains. Statements that best represent these domains have been identified by key stakeholders and will inform the development of a new measure of adherence to exercise for MSK pain.

Moderators of the effect of therapeutic exercise for knee and hip osteoarthritis: a systematic review and individual participant data meta-analysis.

BACKGROUND: Many international clinical guidelines recommend therapeutic exercise as a core treatment for knee and hip osteoarthritis. We aimed to identify individual patient-level moderators of the effect of therapeutic exercise for reducing pain and improving physical function in people with knee osteoarthritis, hip osteoarthritis, or both. METHODS: We did a systematic review and individual participant data (IPD) meta-analysis of randomised controlled trials comparing therapeutic exercise with non-exercise controls in people with knee osteoathritis, hip osteoarthritis, or both. We searched ten databases from March 1, 2012, to Feb 25, 2019, for randomised controlled trials comparing the effects of exercise with non-exercise or other exercise controls on pain and physical function outcomes among people with knee osteoarthritis, hip osteoarthritis, or both. IPD were requested from leads of all eligible randomised controlled trials. 12 potential moderators of interest were explored to ascertain whether they were associated with short-term (12 weeks), medium-term (6 months), and long-term (12 months) effects of exercise on self-reported pain and physical function, in comparison with non-exercise controls. Overall intervention effects were also summarised. This study is prospectively registered on PROSPERO (CRD42017054049). FINDINGS: Of 91 eligible randomised controlled trials that compared exercise with non-exercise controls, IPD from 31 randomised controlled trials (n=4241 participants) were included in the meta-analysis. Randomised controlled trials included participants with knee osteoarthritis (18 [58%] of 31 trials), hip osteoarthritis (six [19%]), or both (seven [23%]) and tested heterogeneous exercise interventions versus heterogeneous non-exercise controls, with variable risk of bias. Summary meta-analysis results showed that, on average, compared with non-exercise controls, therapeutic exercise reduced pain on a standardised 0-100 scale (with 100 corresponding to worst pain), with a difference of -6·36 points (95% CI -8·45 to -4·27, borrowing of strength [BoS] 10·3%, between-study variance [τ2] 21·6) in the short term, -3·77 points (-5·97 to -1·57, BoS 30·0%, τ2 14·4) in the medium term, and -3·43 points (-5·18 to -1·69, BoS 31·7%, τ2 4·5) in the long term. Therapeutic exercise also improved physical function on a standardised 0-100 scale (with 100 corresponding to worst physical function), with a difference of -4·46 points in the short term (95% CI -5·95 to -2·98, BoS 10·5%, τ2 10·1), -2·71 points in the medium term (-4·63 to -0·78, BoS 33·6%, τ2 11·9), and -3·39 points in the long term (-4·97 to -1·81, BoS 34·1%, τ2 6·4). Baseline pain and physical function moderated the effect of exercise on pain and physical function outcomes. Those with higher self-reported pain and physical function scores at baseline (ie, poorer physical function) generally benefited more than those with lower self-reported pain and physical function scores at baseline, with the evidence most certain in the short term (12 weeks). INTERPRETATION: There was evidence of a small, positive overall effect of therapeutic exercise on pain and physical function compared with non-exercise controls. However, this effect is of questionable clinical importance, particularly in the medium and long term. As individuals with higher pain severity and poorer physical function at baseline benefited more than those with lower pain severity and better physical function at baseline, targeting individuals with higher levels of osteoarthritis-related pain and disability for therapeutic exercise might be of merit. FUNDING: Chartered Society of Physiotherapy Charitable Trust and the National Institute for Health and Care Research.

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).

Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial.

OBJECTIVE: To compare the clinical effectiveness of adding a single ultrasound guided intra-articular hip injection of corticosteroid and local anaesthetic to advice and education in adults with hip osteoarthritis. DESIGN: Pragmatic, three arm, parallel group, single blind, randomised controlled trial. SETTING: Two community musculoskeletal services in England. PARTICIPANTS: 199 adults aged ≥40 years with hip osteoarthritis and at least moderate pain: 67 were randomly assigned to receive advice and education (best current treatment (BCT)), 66 to BCT plus ultrasound guided injection of triamcinolone and lidocaine, and 66 to BCT plus ultrasound guided injection of lidocaine. INTERVENTIONS: BCT alone, BCT plus ultrasound guided intra-articular hip injection of 40 mg triamcinolone acetonide and 4 mL 1% lidocaine hydrochloride, or BCT plus ultrasound guided intra-articular hip injection of 5 mL 1% lidocaine. Participants in the ultrasound guided arms were masked to the injection they received. MAIN OUTCOME MEASURES: The primary outcome was self-reported current intensity of hip pain (0-10 Numerical Rating Scale) over six months. Outcomes were self-reported at two weeks and at two, four, and six months. RESULTS: Mean age of the study sample was 62.8 years (standard deviation 10.0) and 113 (57%) were women. Average weighted follow-up rate across time points was 93%. Greater mean improvement in hip pain intensity over six months was reported with BCT plus ultrasound-triamcinolone-lidocaine compared with BCT: mean difference -1.43 (95% confidence interval -2.15 to -0.72), P<0.001; standardised mean difference -0.55 (-0.82 to -0.27). No difference in hip pain intensity over six months was reported between BCT plus ultrasound-triamcinolone-lidocaine compared with BCT plus ultrasound-lidocaine (-0.52 (-1.21 to 0.18)). The presence of ultrasound confirmed synovitis or effusion was associated with a significant interaction effect favouring BCT plus ultrasound-triamcinolone-lidocaine (-1.70 (-3.10 to -0.30)). One participant in the BCT plus ultrasound-triamcinolone-lidocaine group with a bioprosthetic aortic valve died from subacute bacterial endocarditis four months after the intervention, deemed possibly related to the trial treatment. CONCLUSIONS: Ultrasound guided intra-articular hip injection of triamcinolone is a treatment option to add to BCT for people with hip osteoarthritis. TRIAL REGISTRATION: EudraCT 2014-003412-37; ISRCTN50550256.

Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial.

BACKGROUND: Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients' clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists. METHODS AND ANALYSIS: A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions. ETHICS AND DISSEMINATION: North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN28555470.

Guidance for Implementing Best Practice Therapeutic Exercise for Patients With Knee and Hip Osteoarthritis: What Does the Current Evidence Base Tell Us?

Therapeutic exercise is a recommended first-line treatment for patients with knee and hip osteoarthritis (OA); however, there is little specific advice or practical resources to guide clinicians in its implementation. As the first in a series of projects by the Osteoarthritis Research Society International Rehabilitation Discussion Group to address this gap, we aim in this narrative review to synthesize current literature informing the implementation of therapeutic exercise for patients with knee and hip OA, focusing on evidence from systematic reviews and randomized controlled trials. Therapeutic exercise is safe for patients with knee and hip OA. Numerous types of therapeutic exercise (including aerobic, strengthening, neuromuscular, mind-body exercise) may be utilized at varying doses and in different settings to improve pain and function. Benefits from therapeutic exercise appear greater when dosage recommendations from general exercise guidelines for healthy adults are met. However, interim therapeutic exercise goals may also be useful, given that many barriers to achieving these dosages exist among this patient group. Theoretically-informed strategies to improve adherence to therapeutic exercise, such as patient education, goal-setting, monitoring, and feedback, may help maintain participation and optimize clinical benefits over the longer term. Sedentary behavior is also a risk factor for disability and lower quality of life in patients with knee and hip OA, although limited evidence exists regarding how best to reduce this behavior. Current evidence can be used to inform how to implement best practice therapeutic exercise at a sufficient and appropriate dose for patients with knee and hip OA.

Use of the nominal group technique to identify UK stakeholder views of the measures and domains used in the assessment of therapeutic exercise adherence for patients with musculoskeletal disorders.

OBJECTIVES: The objective was to the undertake nominal group technique (NGT) to evaluate current exercise adherence measures and isolated domains to develop stakeholder consensus on the domains to include in the measurement of therapeutic exercise adherence for patients with musculoskeletal disorders. DESIGN: A 1-day NGT workshop was convened. Six exercise adherence measures were presented to the group that were identified in our recent systematic review. Discussions considered these measures and isolated domains of exercise adherence. Following discussions, consensus voting identified stakeholder agreement on the suitability of the six offered adherence measures and the inclusion of isolated domains of exercise adherence in future measurement. SETTING: One stakeholder NGT workshop held in Sheffield, UK. PARTICIPANTS: Key stakeholders from the UK were invited to participate from four identified populations. 14 participants represented patients, clinicians, researchers and service managers. RESULTS: All six exercise adherence measures were deemed not appropriate for use in clinical research or routine practice with no measure reaching 70% group agreement for suitability, relevance, acceptability or appropriateness. Three measures were deemed feasible to use in clinical practice. 25 constructs of exercise adherence did reach consensus threshold and were supported to be included as domains in the future measurement of exercise adherence. CONCLUSION: A mixed UK-based stakeholder group felt these six measures of exercise adherence were unacceptable. Differences in opinion within the stakeholder group highlighted the lack of consensus as to what should be measured, the type of assessment that is required and whose perspective should be sought when assessing exercise adherence. Previously unused domains may be needed alongside current ones, from both a clinician's and patient's perspective, to gain understanding and to inform future measurement development. Further conceptualisation of exercise adherence is required from similar mixed stakeholder groups in various socioeconomic and cultural populations.

Defining adherence to therapeutic exercise for musculoskeletal pain: a systematic review.

OBJECTIVE: To establish the meaning of the term 'adherence' (including conceptual and measurement definitions) in the context of therapeutic exercise (TE) for musculoskeletal (MSK) pain. DESIGN: Systematic review using a search strategy including terms for: adherence, TE and MSK pain. Identified studies were independently screened for inclusion by two researchers. Two independent researchers extracted data on: study type; MSK pain population; type of TE used; definitions, parameters, measurement methods and values of adherence. DATA SOURCES: Seven electronic databases were searched from inception to December 2016. ELIGIBILITY CRITERIA: Any study type featuring TE for adults with MSK pain and containing a definition of adherence, or a description of how adherence was measured. RESULTS: 459 studies were identified and 86 were included in the review. Most were prospective cohort studies and featured back and/or neck pain. Strengthening and stretching were the most common types of TE. A clearly identifiable definition of adherence was provided in 40% of the studies, with 12% using the same definition. Exercise frequency was the most commonly measured parameter of adherence, with self-report logs the most common measurement method. The most common value range used to determine satisfactory adherence was 80%-99% of the recommended exercise dose. CONCLUSION: No single definition of adherence to TE was apparent. We found no definition of adherence that specifically related to TE for MSK pain or described the dimensions of TE that should be measured. We recommend conceptualising adherence to TE for MSK pain from the perspective of all relevant stakeholders.

Do comorbidities predict pain and function in knee osteoarthritis following an exercise intervention, and do they moderate the effect of exercise? Analyses of data from three randomized controlled trials.

BACKGROUND: Although exercise is a core treatment for people with knee osteoarthritis (OA), it is currently unknown whether those with additional comorbidities respond differently to exercise than those without. We explored whether comorbidities predict pain and function following an exercise intervention in people with knee OA, and whether they moderate response to: exercise versus no exercise; and enhanced exercise versus usual exercise-based care. METHODS: We undertook analyses of existing data from three randomized controlled trials (RCTs): TOPIK (n = 217), APEX (n = 352) and Benefits of Effective Exercise for knee Pain (BEEP) (n = 514). All three RCTs included: adults with knee pain attributable to OA; physiotherapy-led exercise; data on six comorbidities (overweight/obesity, pain elsewhere, anxiety/depression, cardiac problems, diabetes mellitus and respiratory conditions); the outcomes of interest (six-month Western Ontario and McMaster Universities Arthritis Index knee pain and function). Adjusted mixed models were fitted where data was available; otherwise linear regression models were used. RESULTS: Obesity compared with underweight/normal body mass index was significantly associated with knee pain following exercise, as was the presence compared with absence of anxiety/depression. The presence of cardiac problems was significantly associated with the effect of enhanced versus usual exercise-based care for knee function, indicating that enhanced exercise may be less effective for improving knee function in people with cardiac problems. Associations for all other potential prognostic factors and moderators were weak and not statistically significant. CONCLUSIONS: Obesity and anxiety/depression predicted pain and function outcomes in people offered an exercise intervention, but only the presence of cardiac problems might moderate the effect of exercise for knee OA. Further confirmatory investigations are required.