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

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

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.

Study Overview

• Status: Completed
• Conditions: Sever's Disease; Calcaneal Apophysitis
• Intervention / Treatment: Other: Podoactiva cutom-made foot orthoses; Other: Podoactiva heel lifts

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50001
    • Alejandro Jesús Almenar Arasanz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: Podoactiva cutom-made foot orthoses; Children had to use the orthotics daily during the intervention period
ACTIVE_COMPARATOR: 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	Other: Podoactiva heel lifts; Children had to use the orthotics daily during the intervention period

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacion Podoactiva

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2019
• Primary Completion (ACTUAL): December 10, 2019
• Study Completion (ACTUAL): February 14, 2020

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (ACTUAL): May 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteitis
• Other Study ID Numbers: Sever insoles-heel lifts

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, participants in this study were not adults and in the informed consent signed there was not indiated this statment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No