CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 110 enrolled
Drug / intervention
Custom-made foot orthoses Versus a flat insoledevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03996980
NCT03996980N/ACompleted
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Effect Mechanism of Custom-made Foot Orthoses on Foot Pronation Subjects and Chronic Low Back Pain: a Randomized Controlled Trial

University of Seville·interventional·Posted Jun 25, 2019·Updated Sep 12, 2025

In Brief

A clinical study evaluating Custom-made foot orthoses Versus a flat insole for Chronic Low Back Pain and Foot Pronation. Completed, enrolled 110 participants across 2 sites.

Detailed Summary

Excessive foot pronation has been recognized as being linked to chronic low back pain (CLBP). The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP Objective: to investigate the effects of wearing custom made foot orthoses compared to placebo orthoses in patients with pronated feet and chronic low back pain (CLBP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low Back Pain, Foot Pronation
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 25, 2019
Enrollment StartJan 15, 2013
Primary CompletionJun 1, 2019
Study CompletionJul 15, 2019
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 7.0 years ago

Interventions

Custom-made foot orthoses Versus a flat insoledevice

Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)