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

NCT07171177 | Completed DMC

• 1 other identifier: USev-Foot 2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Foot Orthoses; Pronation

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 4 weeks after intervention

Secondary Outcomes (2)

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

  Baseline and 4 weeks

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

  Baseline and 4 weeks

Study Arms (2)

Custom-made plantar orthosis (3 mm polyurethane foam + 3 mm polypropylene)

EXPERIMENTAL

Individually manufactured plantar orthosis, moulded to each patient's pronated foot using 3 mm polyurethane foam laminated with 3 mm polypropylene, designed to control excessive pronation and thus potentially alleviate non-specific chronic low back pain.

Device: Foot Orthoses

Arm/Group Title: Placebo Comparator: Flat insole (placebo orthosis) (3 mm polyurethane foam)

PLACEBO COMPARATOR

Flat insole made of 3 mm polyurethane foam without corrective elements, used as a placebo comparator to the custom-made orthosis in the management of non-specific chronic low back pain.

Device: Foot Orthoses

Interventions

Foot Orthoses DEVICE

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

Arm/Group Title: Placebo Comparator: Flat insole (placebo orthosis) (3 mm polyurethane foam); Custom-made plantar orthosis (3 mm polyurethane foam + 3 mm polypropylene)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Universidad de Sevilla

Seville, sevilla, 41008, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: September 12, 2025
• Study Start: April 13, 2021
• Primary Completion: July 15, 2021
• Study Completion: August 1, 2021
• Last Updated: September 12, 2025

Record last verified: 2021-04

Locations

ES (1)