Comparison of Two Different Insole Types in Painful Flexible Flatfoot

Eastern Mediterranean University67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Flatfoot

Interventions

CAD/CAM InsoleDEVICE

A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.

Semi-custom InsoleDEVICE

Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Pain Intensity Measured by 100 mm Visual Analog Scale

The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels. Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week. Changes were calculated as the difference between 8-week follow-up and baseline results.

Time frame: Baseline and week 8

Secondary Outcomes

Change in Quality of Life Assessed With Short Form-36 Scale

The scale scores the health related quality of life with 0 and 100, minimum and maximum levels. Each question is scored between 0-100 and the total score is found by dividing to number of question. Higher score or positive change mean better quality of life in the scale. We used physical health part of it. Changes were calculated as the difference between 8-week follow-up and baseline results.

Time frame: Baseline and week 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.