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Effects of insoles adapted in flip-flop sandals in people with plantar fasciopathy: a randomized, double-blind clinical, controlled study [with consumer summary]
Costa ARA, de Almeida Silva HJ, Mendes AAMT, Scattone Silva R, de Almeida Lins CA, de Souza MC
Clinical Rehabilitation 2020 Mar;34(3):119-158
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate the effects of insoles adapted into flip-flop sandals on pain and function in individuals with plantar fasciopathy (PF). DESIGN: Randomized, double-blind controlled study. SETTING: Physiotherapy clinic of the Faculty of Health Sciences of Trairi, Federal University of Rio Grande do Norte, Santa Cruz, Brazil. SUBJECTS: Sixty-six patients of both genders with PF were randomized into two groups: sandal insole group (SI; n = 34), which received a pair of custom flip-flop sandals with insoles covered with smooth synthetic leather; and plain sandal group (PS; n = 32), which received an identical pair of flip-flop sandals, but without the insoles. INTERVENTIONS: Patients were instructed to wear the flip-flops for 12 weeks for at least 4 hours/day. MAIN MEASURES: Pain (visual analogue scale-VAS) in the morning and at the end of the day were considered primary outcomes. Function (Foot Function Index-FFI and Foot and Ankle Ability Measure-FAAM) and functional capacity (6-minute walk test-6MWT) were considered secondary outcomes. The outcomes were evaluated at baseline and immediately after the intervention by a blind assessor. RESULTS: Between-group differences were observed in terms of morning pain (mean difference (MD) -1.82 cm; 95% confidence interval (CI) -3.3 to -0.3; p = 0.016) and function (MD -0.10; 95% CI -0.19 to -0.01; p = 0.023) after the interventions with the SI group showing superior improvements in comparison to the PS group. CONCLUSION: The use of insoles adapted in flip-flop sandals for 12 weeks was effective at improving pain and function in individuals with PF. LEVEL OF EVIDENCE: 1b.

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