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

University of Seville

Status: Completed

Conditions: Foot Orthoses; Pronation; Low Back Pain

Treatments: Device: Foot Orthoses

Study type: Interventional

Funder types: Other

Identifiers

NCT07171177

USev-Foot 2

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Device: Foot Orthoses

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

Placebo Comparator group

Description:

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.

Treatment:

Device: Foot Orthoses