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

Study Overview
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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.

Official Title
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Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial

Conditions
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Calcaneal Apophysitis, Sever's Disease

Intervention / Treatment
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* Other: Podoactiva cutom-made foot orthoses
* Other: Podoactiva heel lifts


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Custom-made foot orthoses<br>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 | Other: Podoactiva cutom-made foot orthoses<br>* Children had to use the orthotics daily during the intervention period<br>|
| Active Comparator: Heel Lifts<br>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 | Other: Podoactiva heel lifts<br>* Children had to use the orthotics daily during the intervention period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogical scale (VAS) | Subjective Sever´s disease pain perception before and after the intervention measured by the Visual analogical scale (VAS) | At baseine and after the intervention period | 
| Algometry | Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention | At baseine and after the intervention period | 
| Sport activity pain perception | Sever´s disease pain perception measured asking the following question: Do you have pain at sport activity?, before and after intervention | At baseine and after the intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Posture Index (FPI) | values of Foot Posture Index (FPI) test in children with calcaneal apophysistis | At baseline | 
| lunge test values | values of lunge test in children with calcaneal apophysistis | At baseline |