Effect of Insoles in Patients With Systemic Lupus Erythematosus

Not Applicable

Completed

• Conditions: Lupus Erythematosus, Systemic; Foot Orthoses; Musculoskeletal Pain
• Interventions: Device: Placebo; Device: Custom-Made Foot Orthoses

• Registration Number: NCT04098055
• Lead Sponsor: University of Seville

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2019-11-02
• Primary Completion: 2021-02-02
• Study Completion: 2022-02-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	-
Custom-made foot orthoses	Custom-Made Foot Orthoses	-

Primary Outcome Measures

Name	Time	Method
11-point Numeric Pain Rating Scale	1 minute	With a range of 0 = no pain to 10 = pain as bad as it can be.
SF- 12 Quality of Life	10 minutes	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.
Foot Function	5 minutes	Foot Function Index
Foot Disability	5 minutes	Manchester Foot Pain and Disability Index

Trial Locations

Locations (1)

Department of Podiatry; 🇪🇸 Seville, Spain