Prefabricated contoured foot orthoses to reduce pain and increase physical activity in people with hip osteoarthritis: A randomised feasibility trial.

BACKGROUND: Hip osteoarthritis (OA) is a prevalent and burdensome condition that leads to impaired quality of life and a substantial economic burden. Encouraging physical activity, particularly walking, is crucial for OA management, but many individuals with hip OA fail to meet recommended activity levels. Prefabricated contoured foot orthoses have shown promise in improving hip muscle efficiency during walking in laboratory settings, but their real-world feasibility and efficacy remain uncertain. OBJECTIVE: The aim of this study was to assess the feasibility of conducting a fully powered randomised controlled trial (RCT) to evaluate the effectiveness of prefabricated contoured foot orthoses, prescribed via telehealth, in people with hip OA. METHODS: This feasibility trial randomised 27 participants with hip OA into two groups: prefabricated contoured foot orthoses or flat shoe inserts. Feasibility outcomes were assessed, including recruitment rate, adherence, logbook completion, and dropout rate. Patient-reported outcomes and accelerometer-measured physical activity were collected as secondary outcomes. RESULTS: While the recruitment rate was low (0.88 people/week), adherence to the intervention (59%), logbook completion (93%), and dropout rates (7%) met or exceeded our predefined feasibility parameters. Participants found the intervention acceptable, and practicality was demonstrated with minor adverse events. Preliminary efficacy testing indicated that prefabricated contoured foot orthoses positively affected physical activity (adjusted mean difference = 2590 [260 to 4920] steps/day), with comparable outcomes for hip-related quality of life and pain. CONCLUSION: This trial supports proceeding to a fully powered RCT to assess the effect of teleheath prescribed prefabricated contoured foot orthoses on physical activity in people with hip OA. STUDY REGISTRATION NUMBER: National Institutes of Health Trial Registry (NCT05138380).

The Posterior Shoulder Instability Questionnaire: internal consistency, content and criterion validity, responsiveness, and reliability of a new tool for the assessment of posterior shoulder instability.

BACKGROUND: Posterior shoulder instability (PSI) is an increasingly recognized cause of shoulder dysfunction particularly in young active patients and certain athlete populations. When evaluating the efficacy of treatment for PSI, specific outcome measures for this population are essential. The aim of the current research was to describe the development and evaluation of a patient reported outcome measure specific for PSI. METHODS: A retrospective cohort study design of patients with PSI was used to develop and evaluate the "Posterior Shoulder Instability Questionnaire (PSI-Q)". Items for PSI-Q were generated through an expert focus group and existing questionnaires. Preliminary data analysis identified redundancy of items and resulted in the PSI-Q being refined. The final PSI-Q was evaluated on 128 patients with PSI with a structural lesion requiring surgical intervention. Participants were excluded in the absence of a posterior glenohumeral joint lesion. Internal consistency (Cronbach α and corrected item-total correlation), content validity, criterion validity, responsiveness, and test-retest reliability (intraclass correlation coefficient) were examined. Content validity, criterion validity and responsiveness were compared with the Melbourne Instability Shoulder Scale (MISS) and the Western Ontario Shoulder Instability Index (WOSI). The minimum detectable change score (MDC) was calculated. RESULTS: The Cronbach α for the total scale preintervention and postintervention was high (α = 0.97). All five domains (pain, instability/weakness/stiffness, function, occupation and sport, and quality of life and satisfaction) demonstrated acceptable internal consistency for each subsection and the overall score of the scale (α > 0.70). The corrected-item total correlation for each domain was within an acceptable range. The responsiveness of the PSI-Q questionnaire was excellent (effect size, 2.06; standard response mean, 1.34) and was higher than the MISS and WOSI. There were no relevant floor effects and 1 ceiling effect. Reliability was excellent (intraclass correlation coefficient(1,1) = 0.93) and the calculated MDC was 10.9 points. DISCUSSION: This study designed and validated a questionnaire specific for measuring symptoms and function in people with structural PSI requiring surgery. The PSI-Q demonstrates good measurement properties and provides an MDC that is useful for researchers and clinicians. In structural PSI, the PSI-Q has a higher responsiveness and more accurately reflects a patient's overall perceived shoulder status compared to current patient reported outcomes for shoulder instability. The psychometric properties of the PSI-Q are still to be determined in a nonsurgical population.

Effect of a physiotherapy-directed rehabilitation programme on patients with multidirectional instability of the glenohumeral joint: a multimodal interventional MRI study protocol.

INTRODUCTION: Altered neuromuscular control of the scapula and humeral head is a typical feature of multidirectional instability (MDI) of the glenohumeral joint, suggesting a central component to this condition. A previous randomised controlled trial showed MDI patients participating in the Watson Instability Program 1 (WIP1) had significantly improved clinical outcomes compared with a general shoulder strength programme. The aim of this paper is to outline a multimodal MRI protocol to identify potential ameliorative effects of the WIP1 on the brain. METHODS AND ANALYSIS: Thirty female participants aged 18-35 years with right-sided atraumatic MDI and 30 matched controls will be recruited. MDI patients will participate in 24 weeks of the WIP1, involving prescription and progression of a home exercise programme. Multimodal MRI scans will be collected from both groups at baseline and in MDI patients at follow-up. Potential brain changes (primary outcome 1) in MDI patients will be probed using region-of-interest (ROI) and whole-brain approaches. ROIs will depict areas of functional alteration in MDI patients during executed and imagined shoulder movements (MDI vs controls at baseline), then examining the effects of the 24-week WIP1 intervention (baseline vs follow-up in MDI patients only). Whole-brain analyses will examine baseline versus follow-up voxel-wise measures in MDI patients only. Outcome measures used to assess WIP1 efficacy will include the Western Ontario Shoulder Index and the Melbourne Instability Shoulder Score (primary outcomes 2 and 3). Secondary outcomes will include the Tampa Scale for Kinesiophobia, Short Form Orebro, Global Rating of Change Score, muscle strength, scapular upward rotation, programme compliance and adverse events. DISCUSSION: This trial will establish if the WIP1 is associated with brain changes in MDI. ETHICS AND DISSEMINATION: Participant confidentiality will be maintained with publication of results. Swinburne Human Research Ethics Committee (Ref: 20202806-5692). TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trial Registry (ACTRN12621001207808).