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Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial.

ABSTRACT: INTRODUCTION:Knee osteoarthritis (KOA) is a common, disabling and costly medical condition. The patellofemoral joint is a critical source of pain in individuals with KOA, and coexistence of patellofemoral osteoarthritis (PFOA) and tibiofemoral osteoarthritis (TFOA) is sometimes observed. The identification of subgroups with PFOA and customised interventions to correct underlying pathomechanics is beneficial for individuals with KOA. This study aims to evaluate whether a clinic-based patella mobilisation therapy (PMT) leads to significant improvement in pain, physical function and quality of life of individuals with KOA. METHODS AND ANALYSIS:A total of 208 participants with coexistence of PFOA and TFOA will be recruited. A pragmatic randomised clinical trial will be conducted, and participants will be randomised into the PMT and waiting list groups. For the PMT group, three manual mobilisation sessions, along with home-based vastus medialis oblique muscle exercise, will be conducted at 2-month intervals. The waiting list group will continue to receive their usual care, and as an incentive the waiting list group will be offered PMT after the study period is over. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and secondary outcomes include the WOMAC function and stiffness subscales, scores for objective physical function tests (the 30?s chair stand, 40-metre fast-paced walk test, the Timed Up and Go Test), and the EuroQol-5D scores. All outcomes will be evaluated at baseline and 6 months using intention-to-treat and incorporating covariate analysis. ETHICS AND DISSEMINATION:Ethics approval has been obtained (CREC no: 2014.379). Results of the trial will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:ChiCTR-IPC-15006618; Pre-results.

SUBMITTER: Sit RWS

PROVIDER: S-EPMC5857690 | biostudies-other | 2018 Mar

REPOSITORIES: biostudies-other

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Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial.

Sit Regina Wing Shan RWS Chan Keith Kwok Wai KKW Yip Benjamin Hon Kei BHK Zhang Daisy Dexing DD Reeves Kenneth Dean KD Chan Ying Ho YH Chung Vincent Chi Ho VCH Wong Samuel Yeung Shan SYS

BMJ open 20180314 3

<h4>Introduction</h4>Knee osteoarthritis (KOA) is a common, disabling and costly medical condition. The patellofemoral joint is a critical source of pain in individuals with KOA, and coexistence of patellofemoral osteoarthritis (PFOA) and tibiofemoral osteoarthritis (TFOA) is sometimes observed. The identification of subgroups with PFOA and customised interventions to correct underlying pathomechanics is beneficial for individuals with KOA. This study aims to evaluate whether a clinic-based pate ...[more]

PMID: 29540410

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Project description:BackgroundBrace 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 analysisA 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 disseminationNorth 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 numberISRCTN28555470.

Project description:BACKGROUND:Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients' short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care. METHODS/DESIGN:Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically. DISCUSSION:This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care. The findings will have important implications for healthcare commissioners, general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners. It may also serve to delay or prevent some individuals from becoming surgical candidates. TRIAL REGISTRATION ISRCTN:ISRCTN93634563.

Project description:BackgroundDelays in starting physical therapy after hospital discharge worsen deconditioning in older adults. Intervening quickly can minimize the negative effects of deconditioning. Telerehabilitation is a strategy that increases access to rehabilitation, improves clinical outcomes, and reduces costs. This paper presents the protocol for a pragmatic clinical trial that aims to determine the effectiveness and cost-effectiveness of a multi-component intervention offered by telerehabilitation for discharged older adults awaiting physical therapy for any specific medical condition.MethodsThis is a pragmatic randomized controlled clinical trial with two groups: telerehabilitation and control. Participants (n=230) will be recruited among individuals discharged from hospitals who are in the public healthcare system physical therapy waiting lists. The telerehabilitation group will receive a smartphone app with a personalized program (based on individual's functional ability) of resistance, balance, and daily activity training exercises. The intervention will be implemented at the individuals' homes. This group will be monitored weekly by phone and monthly through a face-to-face meeting until they start physical therapy. The control group will adhere to the public healthcare system's usual flow and will be monitored weekly by telephone until they start physical therapy. The primary outcome will be a physical function (Timed Up and Go and 30-s Chair Stand Test). The measurements will take place in baseline, start, and discharge of outpatient physical therapy. The economic evaluations will be performed from the perspective of society and the Brazilian public healthcare system.DiscussionThe study will produce evidence on the effectiveness and cost-effectiveness of multi-component telerehabilitation intervention for discharged older adult patients awaiting physical therapy, providing input that can aid the implementation of similar proposals in other patient groups.Trial registrationBrazilian Registry of Clinical Trials (ReBEC), RBR-9243v7 . Registered on 24 August 2020.

Project description:IntroductionRobotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems.Methods and analysisThe Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems.Ethics and disseminationThe trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate.Trial registration numberISRCTN27624068.

Project description:IntroductionChronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.Methods and analysisThe eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45-85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.Ethics and disseminationThe study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.Trial registration numberACTRN12622000440729.

Project description:BackgroundDespite well-established benefits of physical activity for knee osteoarthritis (OA), nine of ten people with knee OA are inactive. People with knee OA who are inactive often believe that physical activity is dangerous, fearing that it will further damage their joint(s). Such unhelpful beliefs can negatively influence physical activity levels. We aim to evaluate the clinical- and cost-effectiveness of integrating physiotherapist-delivered pain science education (PSE), an evidence-based conceptual change intervention targeting unhelpful pain beliefs by increasing pain knowledge, with an individualised walking, strengthening, and general education program.MethodsTwo-arm, parallel-design, multicentre randomised controlled trial involving 198 people aged ≥50 years with painful knee OA who do not meet physical activity guideline recommendations or walk regularly for exercise. Both groups receive an individualised physiotherapist-led walking, strengthening, and OA/activity education program via 4x weekly in-person treatment sessions, followed by 4 weeks of at-home activities (weekly check-in via telehealth), with follow-up sessions at 3 months (telehealth) and 5 and 9 months (in-person). The EPIPHA-KNEE group also receives contemporary PSE about OA/pain and activity, embedded into all aspects of the intervention. Outcomes are assessed at baseline, 12 weeks, 6 and 12 months. Primary outcomes are physical activity level (step count; wrist-based accelerometry) and self-reported knee symptoms (WOMAC Total score) at 12 months. Secondary outcomes are quality of life, pain intensity, global rating of change, self-efficacy, pain catastrophising, depression, anxiety, stress, fear of movement, knee awareness, OA/activity conceptualisation, and self-regulated learning ability. Additional measures include adherence, adverse events, blinding success, COVID-19 impact on activity, intention to exercise, treatment expectancy/perceived credibility, implicit movement/environmental bias, implicit motor imagery, two-point discrimination, and pain sensitivity to activity. Cost-utility analysis of the EPIPHA-KNEE intervention will be undertaken, in addition to evaluation of cost-effectiveness in the context of primary trial outcomes.DiscussionWe will determine whether the integration of PSE into an individualised OA education, walking, and strengthening program is more effective than receiving the individualised program alone. Findings will inform the development and implementation of future delivery of PSE as part of best practice for people with knee OA.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12620001041943 (13/10/2020).

Dataset Information

Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial.

Publications

Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial.

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