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

NCT ID: NCT07171177

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2021-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Foot Orthoses

Intervention Type: 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)

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.

Group Type: PLACEBO_COMPARATOR

Foot Orthoses

Intervention Type: DEVICE

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

Interventions

Foot Orthoses

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

MANUEL PABON CARRASCO

Principal Investigator, Assistant Professor, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Sevilla

Seville, sevilla, Spain

Countries

Spain

Other Identifiers

USev-Foot 2

Identifier Type: -

Identifier Source: org_study_id