Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis

NCT ID: NCT03960086

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2020-02-14

Brief Summary

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The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis.

It was hypothesized that the primary outcome, pain relief, would be significantly improved with the custom-made orthosis compared to the heel lift.

Detailed Description

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Conditions

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Calcaneal Apophysitis Sever's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Custom-made foot orthoses

Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity.

Treatment period of 12 weeks

Group Type EXPERIMENTAL

Podoactiva cutom-made foot orthoses

Intervention Type OTHER

Children had to use the orthotics daily during the intervention period

Heel Lifts

Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity.

Treatment period of 12 weeks

Group Type ACTIVE_COMPARATOR

Podoactiva heel lifts

Intervention Type OTHER

Children had to use the orthotics daily during the intervention period

Interventions

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Podoactiva cutom-made foot orthoses

Children had to use the orthotics daily during the intervention period

Intervention Type OTHER

Podoactiva heel lifts

Children had to use the orthotics daily during the intervention period

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosed radiologically with calcaneal osteochondritis
* diagnosed radiologically with calcaneal osteochondritis
* have signed informed consent

Exclusion Criteria

* had suffered some trauma on the heel in the past 2 months
* had received anti-inflammatory drugs and/or physical treatment for pain in the past 3 months
* had presented physical or neurological impairment
* were not interested
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Podoactiva

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alejandro Jesús Almenar Arasanz

Zaragoza, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Sever insoles-heel lifts

Identifier Type: -

Identifier Source: org_study_id

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