Context: Athletic pelvic/groin pain is a common yet often challenging problem to both diagnose and manage. A new tool has been developed based on the clinical effects of applied force on the pelvis. Early findings indicate that this customized compression orthosis may have a positive effect on pelvic/groin pain and performance measures.
Objectives: To inform the design and test the practicality of procedures for a future definitively powered randomized controlled trial and to provide an estimate of the effect size of this orthosis on selected clinical and performance measures.
Design: Pilot randomized controlled trial with participants randomly allocated to an intervention or waiting-list control group.
Setting: The training location of each athlete.
Participants: 24 athletes with subacute and chronic pelvic conditions were proposed to be recruited.
Intervention: A customized compression orthosis, delivering targeted compression to the pelvic girdle.
Outcome measures: Measures were the active straight leg raise (ASLR) test, squeeze test, broad jump, and the multiple single-leg hop-stabilization test.
Results: A total of 16 athletes completed the study. The invention group demonstrated moderate to large estimated effect sizes on the squeeze test and active straight leg raise tests (d = 0.6-1.1) while wearing the orthosis. Small effect sizes (d = 0.2) were seen on jump distance and the dominant leg balance score. Compared with the control group, the intervention group also showed moderate to large estimated effect sizes on the active straight leg raise measures (d = 0.5-0.9) when wearing sports shorts.
Conclusions: The protocol was feasible. Effect sizes and recruitment/attrition rates suggest that the intervention holds promise and that a future definitively powered randomized controlled trial appears feasible and is indicated.
Keywords: customized orthosis; shorts; sports; trial.