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

Not Applicable

• Conditions: Foot Pronation; Chronic Low Back Pain
• Interventions: Device: Custom-made foot orthoses Versus a flat insole

• Registration Number: NCT03996980
• Lead Sponsor: University of Seville

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

Study Timeline

• Study Start: 2019-01-15
• Status Verified: 2019-06
• Primary Completion: 2019-06-01
• Study First Submitted: 2019-06-09
• Study First Submitted QC: 2019-06-22
• Last Update Submitted: 2019-06-22
• Study First Posted: 2019-06-25
• Last Update Posted: 2019-06-25
• Study Completion: 2019-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custom-made foot orthoses	Custom-made foot orthoses Versus a flat insole	treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks
Placebo	Custom-made foot orthoses Versus a flat insole	a flat insole for a period of 4 weeks

Primary Outcome Measures

Name	Time	Method
Assess chronic low back pain	After four weeks of use of the orthose treatment.	100 mm visual analogue scale (VAS).The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain
Assess the position of the foot	After four weeks of use of the orthose treatment.	A podiatrist assessed the foot posture during the biomechanical assessment based on the six-item foot posture index (FPI≥+6) 16. The FPI consists of six validated items measured in a standing relaxed position of the subject; The categories are: Supinated foot: -1 a -12. Neutral foot posture: 0 to +5 (neutral). Pronated foot posture: +6 to +12.

Trial Locations

Locations (1)

Manuel Pabón Carrasco; 🇪🇸 Seville, Spain