Effect of Insoles in Patients With Systemic Lupus Erythematosus (EISLE)
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|ClinicalTrials.gov Identifier: NCT04098055|
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic Foot Orthoses Musculoskeletal Pain||Device: Custom-Made Foot Orthoses Device: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous|
|Estimated Study Start Date :||November 2, 2019|
|Estimated Primary Completion Date :||February 2, 2021|
|Estimated Study Completion Date :||November 2, 2021|
|Experimental: Custom-made foot orthoses||
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 Comparator: Control Group||
The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
- 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.
- 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.
- Foot Function [ Time Frame: 5 minutes ]Foot Function Index
- Foot Disability [ Time Frame: 5 minutes ]Manchester Foot Pain and Disability Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098055
|Contact: Pedro V. Munuera-Martínez, PhD.||+email@example.com|