Effect of Insoles in Patients With Systemic Lupus Erythematosus

Musculoskeletal Pain Clinical Trial

— EISLE  

Official title:

Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098055
• Other study ID #: SLE
• Status: Completed
• Phase: N/A
• Start date: November 2, 2019
• Est. completion date: February 2, 2022

Study information

• Verified date: May 2022
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2, 2022
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foot Orthoses
• Lupus Erythematosus, Systemic
• Musculoskeletal Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Department of Podiatry	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. eCollecti — View Citation

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. Review. — View Citation

Reina-Bueno M, Vázquez-Bautista MDC, Pérez-García S, Rosende-Bautista C, Sáez-Díaz A, Munuera-Martínez PV. Effectiveness of custom-made foot orthoses in patients with rheumatoid arthritis: a randomized controlled trial. Clin Rehabil. 2019 Apr;33(4):661-66 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11-point Numeric Pain Rating Scale	With a range of 0 = no pain to 10 = pain as bad as it can be.	1 minute
Primary	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.	10 minutes
Primary	Foot Function	Foot Function Index	5 minutes
Primary	Foot Disability	Manchester Foot Pain and Disability Index	5 minutes