Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Calcaneal Apophysitis
- Sponsor
- Fundacion Podoactiva
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Algometry
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
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)
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
- Foot Posture Index (FPI)(At baseline)
- lunge test values(At baseline)