NCT03996980

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

Completed NA Results posted Last updated 12 September 2025

What this trial tests

NA trial testing Custom-made foot orthoses Versus a flat insole in Chronic Low Back Pain in 110 participants. Completed in 15 July 2019.

Timeline

15 January 2013

Primary endpoint
1 June 2019

15 July 2019

Quick facts

Lead sponsor	University of Seville
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	110
Start date	15 January 2013
Primary completion	1 June 2019
Estimated completion	15 July 2019
Sites	2 locations across Spain

Drugs / interventions tested

• Custom-made foot orthoses Versus a flat insole

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →
• Foot Pronation — all drugs for Foot Pronation →

Sponsor

University of Seville

Who can join

Adults 18 to 65, any sex, with Chronic Low Back Pain or Foot Pronation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain Primary · Baseline

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

Group	Value	95% CI
Custom-made Foot Orthoses	20.45	± 12.51
Placebo	19.02	± 9.5

VAS for Chronic Low Back Pain Primary · Baseline

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)

Group	Value	95% CI
Custom-made Foot Orthoses	6.36	± 0.23
Placebo	6.56	± 0.24

Foot Posture Index Primary · At the moment of inclusion in the study

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.

Group	Value	95% CI
Custom-made Foot Orthoses	5.98	± 1.62
Placebo	6.42	± 1.33

Oswestry Disability Index Questionnaire (ODI) Secondary · at the end of the study, approximately 4 weeks

Oswestry Disability Index Questionnaire (ODI) for chronic low back pain

Group	Value	95% CI
Custom-made Foot Orthoses	7.21	± 6.20
Placebo	21.17	± 8.1

VAS Secondary · At 4 weeks after baseline

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.

Group	Value	95% CI
Custom-made Foot Orthoses	3.02	± 1.80
Placebo	6.54	± 1.51

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Custom-Made Foot Orthoses as Non-Specific Chronic Low Back Pain and Pronated Foot Treatment.
   Castro-Méndez A, Palomo-Toucedo IC, Pabón-Carrasco M, Ramos-Ortega J, et al · · 2021 · cited 6× · PMID 34201981 · DOI 10.3390/ijerph18136816