Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.
Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.
The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.
CTRI/2024/06/068838.
To estimate the direction and magnitude of socioeconomic inequalities in outcome, experience and care among adults consulting for a musculoskeletal pain condition.
Multicentre, prospective observational cohort with repeated measures at three waves (baseline, 3 months and 6 months after index consultation).
30 general practices in North Staffordshire and Stoke-on-Trent, England.
1875 consecutive, eligible, consenting patients, aged 18 years and over, presenting with a relevant SNOMED CT-coded musculoskeletal pain condition between September 2021 and July 2022.
Standard care.
Primary outcome was patient-reported pain and function using the Musculoskeletal Health Questionnaire (MSK-HQ score, 0–56). Secondary outcomes were patient experience (overall dissatisfaction with consultation experience, dichotomised) and an indicator of care received (opioid prescription within 14 days of index consultation). Using multilevel models, we examined inequalities in primary and secondary outcomes by area deprivation (Index of Multiple Deprivation derived from patient residential postcode), before and after adjusting for sociodemographic and survey administration variables, clinical case-mix and selected practice-level covariates.
Compared with patients from the least deprived neighbourhoods, patients from the most deprived neighbourhoods had significantly poorer MSK-HQ scores at baseline (mean 22.6 (SD 10.4) vs 27.6 (10.1)). At 6 months, the inequality gap in MSK-HQ score widened (difference in mean score after adjustment for all covariates: 1.94; 95% CI: –0.70 to 4.58). Opioid prescription was more common for patients living in the most deprived neighbourhoods (30% vs 19%; fully adjusted OR: 0.69; 95% CI: 0.44 to 1.08). Only 6% of patients overall reported being dissatisfied with their consultation. Analysis of multiply imputed data produced a similar pattern of findings to complete-case analysis.
Substantial inequalities in the chronicity, severity and complexity of musculoskeletal pain problems are already present at the time of accessing care. Inequalities in pain and function do not reduce after accessing care and may even widen slightly.
ISRCTN18132064; Results.