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

Primary Purpose

Lupus Erythematosus, Systemic, Foot Orthoses, Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Custom-Made Foot Orthoses
Placebo
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lupus Erythematosus, Systemic focused on measuring Lupus Erythematosus, Systemic, Foot Orthoses, Foot, Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Podiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Custom-made foot orthoses

Control Group

Arm Description

Outcomes

Primary Outcome Measures

11-point Numeric Pain Rating Scale
With a range of 0 = no pain to 10 = pain as bad as it can be.
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.
Foot Function
Foot Function Index
Foot Disability
Manchester Foot Pain and Disability Index

Secondary Outcome Measures

Full Information

First Posted
September 18, 2019
Last Updated
May 18, 2022
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04098055
Brief Title
Effect of Insoles in Patients With Systemic Lupus Erythematosus
Acronym
EISLE
Official Title
Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic, Foot Orthoses, Musculoskeletal Pain
Keywords
Lupus Erythematosus, Systemic, Foot Orthoses, Foot, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Custom-made foot orthoses
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Custom-Made Foot Orthoses
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
Primary Outcome Measure Information:
Title
11-point Numeric Pain Rating Scale
Description
With a range of 0 = no pain to 10 = pain as bad as it can be.
Time Frame
1 minute
Title
SF- 12 Quality of Life
Description
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
Title
Foot Function
Description
Foot Function Index
Time Frame
5 minutes
Title
Foot Disability
Description
Manchester Foot Pain and Disability Index
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Podiatry
City
Seville
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19013374
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.
Results Reference
result
PubMed Identifier
27006702
Citation
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.
Results Reference
result
PubMed Identifier
30556429
Citation
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.
Results Reference
result
PubMed Identifier
33649056
Citation
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.
Results Reference
derived

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Effect of Insoles in Patients With Systemic Lupus Erythematosus

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