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

Fundacion Podoactiva

Status: Completed

Conditions: Sever's Disease; Calcaneal Apophysitis

Treatments: Other: Podoactiva heel lifts; Other: Podoactiva cutom-made foot orthoses

Study type: Interventional

Funder types: Other

Identifiers

NCT03960086

Sever insoles-heel lifts

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 2 patient groups

Custom-made foot orthoses

Experimental group

Description:

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

Treatment:

Other: Podoactiva cutom-made foot orthoses

Heel Lifts

Active Comparator group

Description:

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

Treatment:

Other: Podoactiva heel lifts