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Effectiveness of footwear and foot orthoses for calcaneal apophysitis: a 12-month factorial randomised trial [with consumer summary]
James AM, Williams CM, Haines TP
British Journal of Sports Medicine 2016 Oct;50(20):1268-1275
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: Calcaneal apophysitis, is a relatively common cause of heel pain in children. Very few randomised studies have evaluated treatment options. This trial compared the effectiveness of currently employed treatment options for the relief of pain and disability associated with calcaneal apophysitis. DESIGN: Factorial 2x2 randomised comparative effectiveness trial with 1, 2, 6 and 12-month follow-up. SETTING: Participants were recruited from the caseload of podiatrists at Monash Health and Peninsula Health. PARTICIPANTS: Children aged 8 to 14 years with clinically diagnosed calcaneal apophysitis. INTERVENTIONS: Treatment factor 1: two different types of in-shoe orthoses: a heel raise or prefabricated orthoses. Treatment factor 2: footwear replacement or no footwear replacement. OUTCOMES: Our primary outcome was functional disability, the secondary outcomes were pain and ankle dorsiflexion range. RESULTS: A total of 133 children and their parents responded to the recruitment advertisement, 124 participated in the trial. At the 1 and 2-month follow-up points, there was a main effect of the shoe insert (heel raise) in only the physical domain for the Oxford ankle foot questionnaire (p = 0.04). At the 6 and 12-month follow-up points, there was no main effect or interaction effect for any outcome measure. CONCLUSION: This trial indicates at the 2-month time point there is a relative advantage in the use of heel raises over prefabricated orthoses for the treatment for calcaneal apophysitis. At 12 months there was no relative advantage to any one of the investigated treatment choices over another. Therefore, if a physical impact is experienced for greater than 2 months, the selection of treatment choice may defer to clinical judgement, cost-minimisation and or patient preference. TRIAL REGISTRATION NUMBER: ACTRN12609000696291.
Reproduced with permission from the BMJ Publishing Group.

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