NCT03482518

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

Completed NA Last updated 8 January 2019

What this trial tests

NA trial testing custom slippers with perforated synthetic leather cover. in Heel Pain Syndrome in 66 participants. Completed in 7 January 2019.

Timeline

17 April 2018

Primary endpoint
1 January 2019

7 January 2019

Quick facts

Lead sponsor	Universidade Federal do Rio Grande do Norte
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	66
Start date	17 April 2018
Primary completion	1 January 2019
Estimated completion	7 January 2019
Sites	1 location across Brazil

Drugs / interventions tested

• custom slippers with perforated synthetic leather cover.

Conditions studied

• Heel Pain Syndrome — all drugs for Heel Pain Syndrome →
• Metatarsalgia — all drugs for Metatarsalgia →

Sponsor

Universidade Federal do Rio Grande do Norte — full company profile →

Who can join

Adults 18 to 60, any sex, with Heel Pain Syndrome or Metatarsalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of microcurrent therapy for treatment of acute knee pain: A randomized double-blinded controlled clinical trial.
   Lawson D, Lee KH, Kang HB, Yang N, et al · · 2021 · cited 5× · PMID 33095658 · DOI 10.1177/0269215520965320