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

University of Seville

Status: Completed

Conditions: Chronic Low Back Pain; Foot Pronation

Treatments: Device: Custom-made foot orthoses Versus a flat insole

Study type: Interventional

Funder types: Other

Identifiers

NCT03996980

CRESEUE-Foot

Details and patient eligibility

About

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).

Full 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

Enrollment: 110 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Custom-made foot orthoses

Experimental group

Description:

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

Treatment:

Device: Custom-made foot orthoses Versus a flat insole

Placebo

Placebo Comparator group

Description:

a flat insole for a period of 4 weeks

Treatment:

Device: Custom-made foot orthoses Versus a flat insole