Clinical Trial Adherence to Focal Muscle Spasticity Guidelines: A Systematic Review

Abstract

<h3>Objective(s)</h3> To determine the extent to which current randomised controlled trials (RCT) adhere to a synthesis of guideline recommendations to improve functional outcomes amongst adults with focal spasticity. <h3>Data Sources</h3> Seven electronic databases were searched for papers published from 2010. <h3>Study Selection</h3> Randomised trials were included if they (1) targeted focal spasticity (2) included botulinum toxin-A (3) randomised a physical intervention to the upper or lower limb OR (4) the primary aim related to the activity/participation domains of the International Classification of Functioning. <h3>Data Extraction</h3> Two independent reviewers performed data extraction, as well as quality appraisal according to the Modified PEDro and Modified McMasters Qualitative Review. General research principles were also extracted such as study registration, use of CONSORT guidelines, use of clinical guidelines, TIDieR checklist and protocol publication. <h3>Data Synthesis</h3> Twenty-nine RCTs met the inclusion criteria. SMART goal setting was rarely included (n=5). Not all studies included a measure of focal spasticity, nor a measure of active function despite it being a study aim. One (3%) RCT included patient education. Despite the long-term nature of spasticity management, only 2 studies measured outcomes beyond 6 months. Eight RCTs (28%) incorporated a focal spasticity guideline in their methodology. One RCT used the CERT/TIDIER guidelines. The average Modified PEDro score was 9.9. The average Modified McMasters score was 12.5. <h3>Conclusions</h3> Adherence to focal spasticity guidelines in RCTs was generally low, in addition to low adherence to general research principles. Improving these two key areas may lead to a greater understanding of the relationship between improvements in focal spasticity and its translation to greater functional outcomes. <h3>Author(s) Disclosures</h3> None to declare.