The role of early orthotic intervention in the management of post-traumatic elbow contractures: Study protocol for phase II double-blinded randomised controlled trial.

Background: Restoration of full elbow extension following trauma is difficult and influenced by the injury profile, surgeon preference, patient and environmental factors. The literature suggests that orthotic interventions are effective in improving contractures when movement plateaus despite normal therapeutic interventions. It is not known if extension orthotic intervention is more superior to standard treatment regardless of when it is commenced. The literature lacks patient-reported considerations to contracture management using elbow orthoses. Methods and analysis: This protocol describes a Phase II double blinded randomised controlled feasibility trial (RCT) and mixed methods study, aimed to examine outcome with extension in an orthotic intervention group (OG) versus control (CG). All participants will undergo six weekly therapy sessions, which include a standardised therapeutic program. OG participants will be provided with an additional extension orthosis and the outcome is assessed according to the change in elbow extension motion after 6 weeks of intervention. Data will be collected via questionnaires, logbooks, feedback forms, and semi-structured interviews at baseline and final assessments for descriptive statistical analysis. Under the guidance of a statistician, all quantitative data will be evaluated using the appropriate parametric or non-parametric analyses to evaluate for systematic differences between groups. Preliminary extension gains are used to determine the final sample size required to achieve adequate power for a full-scaled RCT. Interview data on OG participants will be qualitatively analysed using the "five-factorial dimensions of adherence" framework to identify key differences in the influencers between adherent or non-adherent groups. Trial registration number: ANZCTR ACTRN12619001402134p.