Skip to main content
OpenTrials
Completed

NCT Number: NCT07171177

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Foot Orthoses Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pronation Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Sevilla

Seville, sevilla, 41008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foot Orthoses

Device

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

Primary outcomes

  1. Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: 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 outcomes

  1. Change in pain intensity measured by the Numerical Rating Scale (NRS, 0-10)

    Time frame: Baseline and 4 weeks

    The NRS is a 0-10 scale where 0 = no pain and 10 = worst imaginable pain.

  2. Change in foot posture measured by the Foot Posture Index (FPI)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.