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Effectiveness of Postural Insoles Adapted in Slippers for People With Persistent Heel Pain

NCT03482518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-01-08

No results posted yet for this study

Summary

Introduction: Persistent heel pain from plantar fasciitis and calcaneal spurs, as well as metatarsalgia, are very common and prevalent complaints in the Brazilian population. One of the recommended treatments for these conditions in the literature is the use of insoles. However, the use of this feature requires the individual to wear closed shoes and this is an obstacle to treatment in cities with hot weather. Thinking about an alternative treatment, the customized slippers with the corrective elements of the insoles can be an alternative to increase the adhesion to this type of treatment. Objective: To evaluate the effectiveness of the insoles adapted in slippers in the improvement of the pain and the function in individuals with persistent pains in the backfoot of the city of Santa Cruz, RN. Methodology: This is a double-blind, randomized, controlled clinical study in which 66 patients diagnosed with persistent back pain and metatarsalgias will be divided into two groups. The intervention group will receive a customized slipper with foot pieces and synthetic leather cover, and the control group will receive a slipper without customization, only with a synthetic leather cover as used by the intervention group. The evaluator and the patient will be considered blind. Evaluations will be performed at baseline (T0), after 12 weeks of wearing the slippers (T12) and a reassessment at week 16 (T16) for pain monitoring. The evaluation instruments used will be the EVA (visual pain scale) and the algometer in the painful region of the foot; FFI - Foot Function Index questionnaire and FAAM questionnaire - Foot and Ankle Ability Measure for functional evaluation, and finally the 6 - minute walking test for walking performance. Statistical analysis: Data will be analyzed by t-test, Mann-Whitney test, repeated-measures ANOVA and intention-to-treat analysis.

Conditions

  • Heel Pain Syndrome
  • Metatarsalgia

Interventions

OTHER

custom slippers with perforated synthetic leather cover.

the intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover.

Sponsors & Collaborators

  • Universidade Federal do Rio Grande do Norte

    lead OTHER

Principal Investigators

  • Marcelo Cardoso de Souza, PT,PhD · Universidade Federal do Rio Grande do Norte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2019-01-01
Completion
2019-01-07

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482518 on ClinicalTrials.gov