Effect of Insoles in Patients With Systemic Lupus Erythematosus (EISLE)

University of Seville

Status: Completed

Conditions: Musculoskeletal Pain; Foot Orthoses; Lupus Erythematosus, Systemic

Treatments: Device: Custom-Made Foot Orthoses; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04098055

SLE

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Custom-made foot orthoses

Experimental group

Treatment:

Device: Custom-Made Foot Orthoses

Control Group

Placebo Comparator group

Treatment:

Device: Placebo