N/A
N=67
Comparison of Two Different Insole Types in Painful Flexible Flatfoot
Flatfoot
Bottom Line
View on ClinicalTrials.gov: NCT02706327 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Change in Pain Intensity Measured by 100 mm Visual Analog Scale — -31.40; -34.54; -12.08 milimiters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CAD/CAM Insole (Device); Semi-custom Insole (Device); Control (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Mediterranean University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity Measured by 100 mm Visual Analog Scale |
-31.40; -34.54; -12.08 | <0.001 sig |
| SECONDARY Change in Quality of Life Assessed With Short Form-36 Scale |
7.76; 6.68; 2.12 | 0.547 |
Summary
The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.
Eligibility Criteria
Inclusion Criteria
- minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer),
- minimum of + 6 points on the foot posture index,
Exclusion Criteria
- treatment of the foot for at least six months,
- leg length discrepancy of more than 1 cm,
- history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.
Data sourced from ClinicalTrials.gov (NCT02706327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.