Effect of Insoles in Patients With Systemic Lupus Erythematosus

University of Seville40 enrolled

Overview

Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Lupus Erythematosus, Systemic Foot Orthoses Musculoskeletal Pain

Interventions

Custom-Made Foot OrthosesDEVICE

The foot orthoses were custom made using phenolic foam molds of the feet. They consisted of a polypropylene layer of 2 mm from heel to just proximal to the metatarsal heads, an upper sheet of 30 Shore A polyethylene foam.

PlaceboDEVICE

The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or more. * Medical diagnosis of LES. * Foot involvement. Exclusion Criteria: * Treatment with foot orthoses. * LES with acute symptomatic flare. * Ulcers. * Skin involvement. * Neurological problems. * Cognitive deterioration. * Need for walking assistance. * Refused to change footwear to use the foot orthoses.

Locations (1)

Department of Podiatry

Seville, Spain

Outcomes

Primary Outcomes

11-point Numeric Pain Rating Scale

With a range of 0 = no pain to 10 = pain as bad as it can be.

Time frame: 1 minute

SF- 12 Quality of Life

To describe the relationships among functional health status measures. This has values between 0 and 100, with higher values corresponding to lower quality of life.

Time frame: 10 minutes

Foot Function

Foot Function Index

Time frame: 5 minutes

Foot Disability

Manchester Foot Pain and Disability Index

Time frame: 5 minutes

Data from ClinicalTrials.gov

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