Effect of Insoles in Patients With Systemic Lupus Erythematosus (EISLE)
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098055
|Contact: Pedro V. Munuera-Martínez, PhD.||+email@example.com|