An interventional study of Custom-Made Foot Orthoses and Placebo in Lupus Erythematosus, Systemic, Foot Orthoses and Musculoskeletal Pain, sponsored by University of Seville. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-19.
Sponsored by University of Seville · Not applicable, Interventional, and Other
Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 40 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →University of Seville is the lead sponsor of 127 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Custom-Made Foot Orthoses
Device: Placebo
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.
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
With a range of 0 = no pain to 10 = pain as bad as it can be.
Time frame: 1 minute
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.
Time frame: 10 minutes
Foot Function
Foot Function Index
Time frame: 5 minutes
Foot Disability
Manchester Foot Pain and Disability Index
Time frame: 5 minutes
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Seville