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

Not Applicable

Completed

• Conditions: Calcaneal Apophysitis; Sever's Disease
• Interventions: Other: Podoactiva cutom-made foot orthoses; Other: Podoactiva heel lifts

• Registration Number: NCT03960086
• Lead Sponsor: Fundacion Podoactiva

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Study Start: 2019-06-12
• Primary Completion: 2019-12-10
• Study Completion: 2020-02-14
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custom-made foot orthoses	Podoactiva cutom-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
Heel Lifts	Podoactiva 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Foot Posture Index (FPI)	At baseline	values of Foot Posture Index (FPI) test in children with calcaneal apophysistis
lunge test values	At baseline	values of lunge test in children with calcaneal apophysistis

Trial Locations

Locations (1)

Alejandro Jesús Almenar Arasanz; 🇪🇸 Zaragoza, Spain