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

NCT03960086 | Completed

• 1 other identifier: Sever insoles-heel lifts
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcaneal Apophysitis; Sever's Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Foot Posture Index (FPI)

  At baseline

• lunge test values

  At baseline

Study Arms (2)

Custom-made foot orthoses

EXPERIMENTAL

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

Heel Lifts

ACTIVE COMPARATOR

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

Interventions

Podoactiva cutom-made foot orthoses OTHER

Children had to use the orthotics daily during the intervention period

Custom-made foot orthoses

Podoactiva heel lifts OTHER

Children had to use the orthotics daily during the intervention period

Heel Lifts

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed radiologically with calcaneal osteochondritis
• diagnosed radiologically with calcaneal osteochondritis
• have signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Podoactiva: lead

Study Sites (1)

Alejandro Jesús Almenar Arasanz

Zaragoza, 50001, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 22, 2019
• Study Start: June 12, 2019
• Primary Completion: December 10, 2019
• Study Completion: February 14, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)