Effectiveness of the Fixtoe Device® in plantar pressure reduction: a preliminary study

BACKGROUND: Metatarsalgia is a common foot condition. The metatarsophalangeal stabilizing taping technique described by Yu et al. has shown good clinical results as a provisional treatment in propulsive metatarsalgia. (35) The Fixtoe Device®, a novel orthopedic device, intends to simulate stabilizing tape. However, to date, there is no evidence of its effectiveness. The aim of this study was to assess plantar pressure changes using the Fixtoe Device®, in comparison with the traditional method (stabilizing tape) in a young, healthy sample thorough a cross-sectional study. METHODS: Maximal pressure (Kpa) and pressure–time integral (Kpa/s) in the second metatarsal head were measured in twenty-four healthy volunteers. Registers were taken in four different conditions: barefoot, traditional stabilizing tape, Fixtoe Device® without metatarsal pad, and Fixtoe Device® with metatarsal pad. RESULTS: Mean second metatarsal head maximal pressure and mean pressure–time integral showed statistical difference among the four analyzed conditions (p < 0.0001 in both cases). The improvement in maximal pressure and pressure–time integral obtained in each intervention also showed significance (p < 0.0001 in both cases). Comparing the improvement of the Fixtoe Device® with and without metatarsal pad with that of tape condition showed a moderate to high and moderate effect size for both peak pressure and pressure–time integral reduction. CONCLUSIONS: The Fixtoe Device® reduces median maximal pressure and median pressure–time integral under the second metatarsal head in healthy young individuals. The Fixtoe Device® shows higher effectiveness than the traditional second metatarsophalangeal joint stabilizing taping technique. To our knowledge, this is the first investigation proving the effectiveness of the recently developed Fixtoe Device® in terms of plantar pressure modification, which leads the way to its use in clinics.