N/A
N=110
Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain
Chronic Low Back Pain · Foot Pronation
Bottom Line
View on ClinicalTrials.gov: NCT03996980 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain — 20.45; 19.02 Score on 0-100% scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Custom-made foot orthoses Versus a flat insole (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Seville
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain |
20.45; 19.02 | — |
| PRIMARY VAS for Chronic Low Back Pain |
6.36; 6.56 | — |
| PRIMARY Foot Posture Index |
5.98; 6.42 | — |
| SECONDARY Oswestry Disability Index Questionnaire (ODI) |
7.21; 21.17 | — |
| SECONDARY VAS |
3.02; 6.54 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03996980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.