Effects of custom insoles for symptomatic hallux valgus: protocol for a sham-controlled randomised trial.

INTRODUCTION: Hallux valgus (HV) is one of the most prevalent forefoot deformities, and its frequency increases with age, reaching nearly 23% in adulthood (females are usually more affected). Studies on customised insoles and orthoses for HV showed inconclusive results. There is no consensus in literature regarding the ideal insole or length of use for pain relief or functional improvement in individuals with HV. This study will assess the effects of a customised insole with retrocapital bar associated with an infracapital bar of the first metatarsal on pain and function of individuals with symptomatic HV. METHODS: This is the protocol for a blinded, sham-controlled randomised clinical trial. Eighty participants with symptomatic HV will be randomised into two groups (40 per group): customised insole or sham insole. Assessments will be performed at baseline (T0), six (T6) and 12 weeks (T12) of intervention. A follow-up will occur after 4 weeks of intervention (T16). The primary and secondary outcomes will be pain (Numerical Pain Scale) and function (Foot Function Index), respectively. STATISTICAL ANALYSIS: Analysis of variance with a mixed design or Friedman's test will be considered according to data distribution; post-hoc analyses will be performed using Bonferroni test. Time × group interaction and within-group and between-group differences will also be assessed. The intent-to-treat analysis will be used. A significance level of 5% and 95% s will be adopted for all statistical analyses. ETHICS AND DISSEMINATION: This protocol was approved by the research ethics committee of the Faculty of Health Sciences of Trairi/Federal University of Rio Grande do Norte (UFRN/FACISA; opinion number 5411306). The study results will be disseminated to participants, submitted to a peer-reviewed journal and presented in scientific meetings. TRIAL REGISTRATIONS NUMBER: NCT05408156.

Main types of insoles described in the literature and their applicability for musculoskeletal disorders of the lower limbs: A systematic review of clinical studies.

The objective of this review was to identify the main types of insoles described in the literature that are used to treat musculoskeletal alterations of lower limbs and to analyze the existence of previous evaluation for the prescription of these insoles. To this end, two researchers, independently and blindly, searched the PubMed, SciELO, Bireme, MEDLINE, Lilacs, PEDro, Cochrane Library and Web of Science databases between June and July of 2018, from the free combination of the following descriptors: insoles, foot orthoses, foot, orthoses, musculoskeletal diseases and clinical trial. We included randomized or non-randomized clinical trials in which at least one intervention group used insoles and individuals with some type of musculoskeletal disorder had been sampled. Of the 227 documents identified in date bases, 20 were included in this review. In general, it is suggested to carry out more studies with more precise methods and that include evaluation before the prescription. This is a systematic review of clinical trials registered in PROSPERO (International Prospective Register of Systematic Reviews) under the protocol no. CRD42018099534e.

Effects of insoles adapted in flip-flop sandals in people with plantar fasciopathy: a randomized, double-blind clinical, controlled study.

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.