Exercise handout and one-on-one hand therapy for management of stiffness after plaster cast immobilization of simple phalangeal and metacarpal fractures in children: A randomized, noninferiority trial

Study Design This is a noninferior, single-blind, randomized controlled trial. Introduction Joint stiffness is common after plaster cast immobilization for simple phalanx and metacarpal fractures in children. The limited literature suggests this joint stiffness in children resolves without one-on-one therapy; however, without robust studies confirming that there is no detrimental effect from withdrawing treatment, many children are still referred. Purpose of the Study The purpose of this study was to determine if an educational handout for self-management of stiffness is noninferior to one-on-one hand therapy for achieving full range of motion (ROM). Methods Participants were randomly assigned to group one who received the handout or group two who received hand therapy in addition to the handout. The ROM was measured by composite flexion and total active motion (TAM). The noninferiority margin was 10% difference between the two groups in the proportion of participants who achieved full ROM at two weeks after cast removal. Results Sixty participants in each group completed the study. Group difference for composite flexion was 1.7% (95% CI: −3.9% to 7.2%), demonstrating noninferiority. Group difference for TAM was inconclusive at 8.3% (95% CI: −2.1% to 18.7%). Sensitivity analysis adjusting for participants with full composite flexion at the baseline resulted in the group difference for composite flexion of 3.1% (95% CI: −3.6% to 9.8%), maintaining noninferiority, but group difference for TAM at 10.4% (95% CI: 0.0% to 20.9%), was inconclusive with the handout group significantly worse. Conclusion An educational handout is noninferior to hand therapy for achieving full ROM in composite flexion but not TAM. This needs to be taken into consideration for changing clinical practise.