NCT03996980

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2013-01-15
• Primary completion: 2019-06-01
• Completion: 2019-07-15
• First posted: 2019-06-25
• Last updated: 2025-09-12
• Results posted: 2025-09-12

Locations

2 sites across 1 country: Spain