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Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain

NCT03996980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-09-12

Study results available
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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).

Conditions

  • Chronic Low Back Pain
  • Foot Pronation

Interventions

DEVICE

Custom-made foot orthoses Versus a flat insole

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

Sponsors & Collaborators

  • University of Seville

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-15
Primary Completion
2019-06-01
Completion
2019-07-15

Countries

  • Spain

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 NCT03996980 on ClinicalTrials.gov