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

NCT ID: NCT03996980

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-15
• Study Completion Date: 2019-07-15

Brief 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).

Detailed Description

Excessive foot pronation has been recognized as being linked to CLBP. Foot hyperpronation may cause malalignment of the lower extremity.There is a wide variety of treatments for CLBP, and it is suggested that excessive pronation of the foot has been linked to CLBP.The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP.

Customized foot orthoses alter the position of the foot during weight-bearing. The goal is to eliminate compensation of the foot due to structural deformity or misalignment and redistribute abnormal plantar pressures.Custom-made foot orthoses may contribute to improving chronic low back pain. This question represents an important benefit for patients and for the public health system by reducing expensive treatments, such as surgery or long periods of rehabilitation

Conditions

Chronic Low Back Pain; Foot Pronation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Custom-made foot orthoses

treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks

Group Type: EXPERIMENTAL

Custom-made foot orthoses Versus a flat insole

Intervention Type: DEVICE

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

Placebo

a flat insole for a period of 4 weeks

Group Type: PLACEBO_COMPARATOR

Custom-made foot orthoses Versus a flat insole

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Males and females between 18 and 65 years old
• Presence of CLBP
• Foot Posture Index pronated in one or both feet (henceforth, FPI) ≥ +6

Exclusion Criteria

• Serious illness
• Current participation in another research study
• Pregnancy
• Previous back or foot surgery
• Current treatment of foot pathology or back, and leg length discrepancy > 5 mm

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

MANUEL PABON CARRASCO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

university. Departament of Podiatry

Seville, , Spain

Manuel Pabón Carrasco

Seville, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRESEUE-Foot

Identifier Type: -

Identifier Source: org_study_id