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Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom-made foot orthoses | Experimental |
| |
| Control Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom-Made Foot Orthoses | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 11-point Numeric Pain Rating Scale | With a range of 0 = no pain to 10 = pain as bad as it can be. | 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. | 10 minutes |
| Foot Function | Foot Function Index | 5 minutes |
| Foot Disability | Manchester Foot Pain and Disability Index | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Podiatry | Seville | 41009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19013374 | Result | Pipili C, Sfritzeri A, Cholongitas E. Deforming arthropathy in systemic lupus erythematosus. Eur J Intern Med. 2008 Nov;19(7):482-7. doi: 10.1016/j.ejim.2008.01.017. Epub 2008 Apr 1. | |
| 27006702 | Result | Otter SJ, Kumar S, Gow P, Dalbeth N, Corkill M, Rohan M, Davies KA, Pankathelam S, Rome K. Patterns of foot complaints in systemic lupus erythematosus: a cross sectional survey. J Foot Ankle Res. 2016 Mar 22;9:10. doi: 10.1186/s13047-016-0143-8. eCollection 2016. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo | Device | The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam. |
|
| 30556429 | Result | Reina-Bueno M, Vazquez-Bautista MDC, Perez-Garcia S, Rosende-Bautista C, Saez-Diaz A, Munuera-Martinez PV. Effectiveness of custom-made foot orthoses in patients with rheumatoid arthritis: a randomized controlled trial. Clin Rehabil. 2019 Apr;33(4):661-669. doi: 10.1177/0269215518819118. Epub 2018 Dec 17. |
| 33649056 | Derived | Reina-Bueno M, Vazquez-Bautista MDC, Palomo-Toucedo IC, Dominguez-Maldonado G, Castillo-Lopez JM, Ramos-Ortega J, Munuera-Martinez PV. Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 1;11(3):e042627. doi: 10.1136/bmjopen-2020-042627. |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |