Efeitos de palmilhas adaptadas em chinelos para dor persistente no retropé: um ensaio controlado e aleatorizado

Abstract

Background: Persistent heel pain is a common condition in the middle-aged adult population, and is often disabling because it affects the individual's functionality and social aspects. The treatment with insoles is widely investigated, although there is disagreement between the evidences. Because it is a practical and comfortable resource, insoles adapted in flip-flops sandals have recently been investigated in clinical studies with plantar fasciopathy. However, the effects on individuals with persistent heel pain are not yet known. Objective: To evaluate the effects of using insoles adapted for flip-flops sandals in the short and medium term on the intensity of morning pain, pain when walking, foot function and functional walking capacity of individuals with persistent heel pain. Methods: Randomized, double-blind, sham-controlled clinical trial registered prospectively in Clinical Trials (NCT04784598). The participants were randomized into two groups: the experimental group (n=40) who used insoles adapted to flipflop sandals, delivered according to the assessment of the type of foot, and the control group (n=40), who used flip-flop sandals with sham insoles, that is, flat sandals. All participants were instructed to wear flip-flops sandals daily, for at least four hours a day, for a period of 12 weeks. Assessments were performed at baseline (T0), after six (T6) and 12 (T12) weeks and after a 4- week follow-up (T16). The primary outcome was morning pain intensity, according to the Numerical Rating Pain Scale. Secondary outcomes were foot function, by the Foot Function Index, and functional walking ability, by the Six-Minute Walk Test. Analysis of variance with amixed design was used and the interaction between time and group was considered for all variables. Results: There were no differences between groups for morning pain intensity and when walking throughout the day in short (at morning → mean difference [MD] = -0.7 [95% CI -1.9 to 0.6]; at walking → MD= -0.4 [CI 95% -0.6 to 0.8]) and in the middle (at morning → MD = 0.01 [CI 95% -1.4 to 1.4]; walking → MD = -0.5 [95% CI -1.8 to 0.8]) timeframes. There were also no differences between groups for secondary outcomes for both time points. No clinically important changes were seen for any of the primary and secondary outcomes. Conclusion: Insoles adapted in flip-flop sandals were not superior to flip-flop sandals with sham insoles for pain, function, and functional capacity outcomes in individuals with persistent heel pain.