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Clinical Trials/NCT04098055
NCT04098055
Completed
N/A

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

University of Seville1 site in 1 country40 target enrollmentNovember 2, 2019
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ConditionsLupus Erythematosus, SystemicFoot OrthosesMusculoskeletal Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lupus Erythematosus, Systemic
Sponsor
University of Seville
Enrollment
40
Locations
1
Primary Endpoint
11-point Numeric Pain Rating Scale
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 2, 2019
End Date
February 2, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pedro V. Munuera-Martínez

Director

University of Seville

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.
  • •Skin involvement.
  • •Neurological problems.
  • •Cognitive deterioration.
  • •Need for walking assistance.
  • •Refused to change footwear to use the foot orthoses.

Outcomes

Primary Outcomes

11-point Numeric Pain Rating Scale

Time Frame: 1 minute

With a range of 0 = no pain to 10 = pain as bad as it can be.

Foot Function

Time Frame: 5 minutes

Foot Function Index

Foot Disability

Time Frame: 5 minutes

Manchester Foot Pain and Disability Index

SF- 12 Quality of Life

Time Frame: 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.

Study Sites (1)

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