Effect of Insoles in Patients With Systemic Lupus Erythematosus
NCT ID: NCT04098055
Last Updated: 2022-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-11-02
2022-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Custom-made foot orthoses
Custom-Made Foot Orthoses
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.
Control Group
Placebo
The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
Interventions
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Custom-Made Foot Orthoses
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.
Placebo
The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
Eligibility Criteria
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Inclusion Criteria
* Medical diagnosis of LES.
* Foot involvement.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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University of Seville
OTHER
Responsible Party
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Pedro V. Munuera-Martínez
Director
Locations
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Department of Podiatry
Seville, , Spain
Countries
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References
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Pipili C, Sfritzeri A, Cholongitas E. Deforming arthropathy in systemic lupus erythematosus. Eur J Intern Med. 2008 Nov;19(7):482-7. doi: 10.1016/j.ejim.2008.01.017. Epub 2008 Apr 1.
Otter SJ, Kumar S, Gow P, Dalbeth N, Corkill M, Rohan M, Davies KA, Pankathelam S, Rome K. Patterns of foot complaints in systemic lupus erythematosus: a cross sectional survey. J Foot Ankle Res. 2016 Mar 22;9:10. doi: 10.1186/s13047-016-0143-8. eCollection 2016.
Reina-Bueno M, Vazquez-Bautista MDC, Perez-Garcia S, Rosende-Bautista C, Saez-Diaz A, Munuera-Martinez PV. Effectiveness of custom-made foot orthoses in patients with rheumatoid arthritis: a randomized controlled trial. Clin Rehabil. 2019 Apr;33(4):661-669. doi: 10.1177/0269215518819118. Epub 2018 Dec 17.
Reina-Bueno M, Vazquez-Bautista MDC, Palomo-Toucedo IC, Dominguez-Maldonado G, Castillo-Lopez JM, Ramos-Ortega J, Munuera-Martinez PV. Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 1;11(3):e042627. doi: 10.1136/bmjopen-2020-042627.
Other Identifiers
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SLE
Identifier Type: -
Identifier Source: org_study_id
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