Disability and Pain in Chronic Low Back Pain and Pronated Foot Treated

Disability and Pain in Men and Women With Chronic Low Back Pain and Pronated Foot Treated With Custom-made Foot Orthoses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07171177

Enrollment

100

Registered

2025-09-12

Start date

2021-04-13

Completion date

2021-08-01

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Orthoses, Low Back Pain, Pronation

Brief summary

Purpose: excessive foot pronation has been reported as being related to chronic low back symptoms. Compensating custom-made foot orthotics treatment has not been entirely explored as an effective therapy for chronic low back pain (CLBP). This study aims to observe the effects of custom made foot orthoses, in subjects with foot pronation suffering from CLBP.

Interventions

DEVICEFoot Orthoses

To compare the use of handmade plantar orthoses versus the use of splints in the management of low back pain.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Women and men adults up to 65 years old, * presence of Chronic Low Back Pain * 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 a foot or back pathology * Leg length discrepancy \> 5 mm

Design outcomes

Primary

Measure	Time frame	Description
Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ)	Baseline and 4 weeks after intervention	The RMDQ is a 24-item self-reported questionnaire designed to assess physical disability due to low back pain. Scores range from 0 to 24, with higher scores indicating greater disability.

Secondary

Measure	Time frame	Description
Change in pain intensity measured by the Numerical Rating Scale (NRS, 0-10)	Baseline and 4 weeks	The NRS is a 0-10 scale where 0 = no pain and 10 = worst imaginable pain.
Change in foot posture measured by the Foot Posture Index (FPI)	Baseline and 4 weeks	The FPI is a 6-item clinical tool for quantifying foot posture. Total scores range from -12 (highly supinated) to +12 (highly pronated).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026