Calcaneal Apophysitis, Sever's Disease
Conditions
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.
Interventions
OTHERPodoactiva cutom-made foot orthoses
Children had to use the orthotics daily during the intervention period
OTHERPodoactiva heel lifts
Children had to use the orthotics daily during the intervention period
Sponsors
Fundacion Podoactiva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogical scale (VAS) | 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) |
| Algometry | At baseine and after the intervention period | Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention |
| Sport activity pain perception | 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
| Measure | Time frame | Description |
|---|---|---|
| Foot Posture Index (FPI) | At baseline | values of Foot Posture Index (FPI) test in children with calcaneal apophysistis |
| lunge test values | At baseline | values of lunge test in children with calcaneal apophysistis |
Countries
Spain
Outcome results
None listed