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Completed

NCT Number: NCT03960086

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

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.

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Key information

Conditions

Calcaneal Apophysitis Sever's Disease

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alejandro Jesús Almenar Arasanz

Zaragoza, 50001, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Podoactiva cutom-made foot orthoses

Other

Children had to use the orthotics daily during the intervention period

Podoactiva heel lifts

Other

Children had to use the orthotics daily during the intervention period

Primary outcomes

  1. Visual analogical scale (VAS)

    Time frame: 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)

  2. Algometry

    Time frame: At baseine and after the intervention period

    Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention

  3. Sport activity pain perception

    Time frame: 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 outcomes

  1. Foot Posture Index (FPI)

    Time frame: At baseline

    values of Foot Posture Index (FPI) test in children with calcaneal apophysistis

  2. lunge test values

    Time frame: At baseline

    values of lunge test in children with calcaneal apophysistis

Sponsors and collaborators

Lead sponsor

Fundacion Podoactiva

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 22, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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