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A randomised controlled trial assessing the impact of footwear, heel raises and orthoses on pain relief in children with calcaneal aphophysitis ("Sever's")

For children in pain with Calcaneal Apophysitis, how do footwear, heel raises or pre-fabricated orthoses impact pain relief.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000696291
Enrollment
124
Registered
2009-08-12
Start date
2010-05-08
Completion date
2013-01-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study seeks to establish a clinically evidenced base treatment options for the relief of pain associated with calcaneal apophysitis in children between the ages of eight and fourteen years of age. The heel bone is located at the most posterior plantar aspect of the foot. The Achilles tendon attaches into the posterior, lower aspect of the calcaneus and near this attachment is the calcaneus secondary growth centre. This is the site of pain experienced during Calcaneal apophysitsis. Treatment within this study includes two levels of shoe orthoses. A heel raise or prefabricated orthoses. Both of these interventions are widely available, mutually exclusive treatment approaches that are relatively low in cost. The footwear prescription/replacement intervention involves a shoe with a firm heel counter, dual density EVA midsole, and rear foot control. The alternate condition in this factor is “no footwear prescription/replacement” with the participant wearing their own footwear.

Interventions

Shoe and heel raises - Heel raise with new footwear - Heel raise with current footwear Heel raises are made from high density ethylene vinyl acetate (EVA). Heel raises are to be worn for the period of the trial/pain. Removal of the device at a point of pain free. The children are to continue with their every day activities whilst wearing the treatment device. The footwear prescription/replacement intervention involves a shoe with a firm heel counter, dual density EVA midsole, rear foot control a

Shoe and heel raises - Heel raise with new footwear - Heel raise with current footwear Heel raises are made from high density ethylene vinyl acetate (EVA). Heel raises are to be worn for the period of the trial/pain. Removal of the device at a point of pain free. The children are to continue with their every day activities whilst wearing the treatment device. The footwear prescription/replacement intervention involves a shoe with a firm heel counter, dual density EVA midsole, rear foot control and an arch support. The intervention period for thi interventions is 2 months with followup period of 12 months.

Sponsors

Dr Terry Haines
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
8 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

- Children between the ages of eight to twelve years. - Subjective report of pain located on the calcaneal apophysis (ie. posterior aspect of heel) with pain on palpation

Exclusion criteria

- Recently (last 12 months) diagnosed fracture or tumour of the foot or leg - Diagnosed infective, reactive or rheumatoid arthritis

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 1, 2026