Effect of Insoles in Patients With Systemic Lupus Erythematosus
NCT04098055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2022-05-19
Summary
Demonstrate that custom-made insoles improve painful symptomatology, health and foot function in subjects with SLE and podiatric involvement.
Conditions
- Lupus Erythematosus, Systemic
- Foot Orthoses
- Musculoskeletal Pain
Interventions
- 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.
- DEVICE
-
Placebo
The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
Sponsors & Collaborators
-
University of Seville
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-02
- Primary Completion
- 2021-02-02
- Completion
- 2022-02-02
Countries
- Spain
Study Locations
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