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

Sever's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960086
• Other study ID #: Sever insoles-heel lifts
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: February 14, 2020

Study information

• Verified date: October 2020
• Source: Fundacion Podoactiva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: February 14, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcaneal Apophysitis
• Osteitis
• Sever's Disease

Intervention

Other:
• Podoactiva cutom-made foot orthoses
Children had to use the orthotics daily during the intervention period
• Podoactiva heel lifts
Children had to use the orthotics daily during the intervention period

Locations

Country	Name	City	State
Spain	Alejandro Jesús Almenar Arasanz	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Podoactiva

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Algometry	Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention	At baseine and after the intervention period
Primary	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	Foot Posture Index (FPI)	values of Foot Posture Index (FPI) test in children with calcaneal apophysistis	At baseline
Secondary	lunge test values	values of lunge test in children with calcaneal apophysistis	At baseline