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

Not Applicable

Completed

• Conditions: Low Back Pain; Foot Orthoses; Pronation

• Registration Number: NCT07171177
• Lead Sponsor: University of Seville

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-13
• Study First Submitted: 2021-04-26
• Primary Completion: 2021-07-15
• Study Completion: 2021-08-01
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Universidad de Sevilla; 🇪🇸 Seville, sevilla, Spain