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

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 Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Foot Pronation
• Intervention / Treatment: Device: Custom-made foot orthoses Versus a flat insole

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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41009
    • university. Departament of Podiatry
  • Seville, Spain
    • Manuel Pabón Carrasco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Custom-made foot orthoses; treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks	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)
Placebo Comparator: Placebo; a flat insole for a period of 4 weeks	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain	This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.The test is considered the 'gold standard' of low back functional outcome tools 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.	Baseline
VAS for Chronic Low Back Pain	10 visual analogue scale (VAS).The findings suggested that 10 VAS ratings of no pain (0-2), mild pain(2-4), moderate pain (4-7), and severe pain (7-10)	Baseline
Foot Posture Index	Foot posture was assessed by a podiatrist during the biomechanical assessment based on the six-item foot posture index (FPI≥+6). The FPI consists of six validated items that are measured in a relaxed standing position of the subject. Each item is assessed on a -2 to +2 scale, where -2 indicates a supinated position, 0 indicates a neutral position and +2 indicates a pronated position, depending on the specific item. The sum of the scores of the six items provides a total score ranging from -12 to +12.	At the moment of inclusion in the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index Questionnaire (ODI)	Oswestry Disability Index Questionnaire (ODI) for chronic low back pain	at the end of the study, approximately 4 weeks
VAS	VAS scale for CLBP Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity.	At 4 weeks after baseline

Collaborators and Investigators

• Sponsor: University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2013
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): July 15, 2019

Study Registration Dates

• First Submitted: June 9, 2019
• First Submitted That Met QC Criteria: June 22, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Low back pain; posture; Foot; pronation; custom-made foot orthoses
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: CRESEUE-Foot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No