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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960086
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Fundacion Podoactiva

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.


Condition or disease Intervention/treatment Phase
Calcaneal Apophysitis Sever's Disease Other: Podoactiva cutom-made foot orthoses Other: Podoactiva heel lifts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial
Actual Study Start Date : June 12, 2019
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : February 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960086


Locations
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Spain
Alejandro Jesús Almenar Arasanz
Zaragoza, Spain, 50001
Sponsors and Collaborators
Fundacion Podoactiva
  Study Documents (Full-Text)

Documents provided by Fundacion Podoactiva:
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Responsible Party: Fundacion Podoactiva
ClinicalTrials.gov Identifier: NCT03960086    
Other Study ID Numbers: Sever insoles-heel lifts
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No, participants in this study were not adults and in the informed consent signed there was not indiated this statment

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteitis
Bone Diseases
Musculoskeletal Diseases