Foot Orthoses, Lupus Erythematosus, Systemic, Musculoskeletal Pain
Conditions
Keywords
Lupus Erythematosus, Systemic, Foot Orthoses, Foot, Pain
Brief summary
Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.
Interventions
DEVICECustom-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.
DEVICEPlacebo
The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 11-point Numeric Pain Rating Scale | 1 minute | With a range of 0 = no pain to 10 = pain as bad as it can be. |
| SF- 12 Quality of Life | 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 | 5 minutes | Foot Function Index |
| Foot Disability | 5 minutes | Manchester Foot Pain and Disability Index |
Countries
Spain
Outcome results
None listed