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Effectiveness of customised foot orthoses for Achilles tendinopathy: a randomised controlled trial [with consumer summary]
Munteanu SE, Scott LA, Bonanno DR, Landorf KB, Pizzari T, Cook JL, Menz HB
British Journal of Sports Medicine 2015 Aug;49(15):989-994
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIM: To evaluate the effectiveness of customised foot orthoses in chronic mid-portion Achilles tendinopathy. METHODS: This was a participant-blinded, parallel-group randomised controlled trial at a single centre (La Trobe University, Melbourne, Australia). One hundred and forty participants aged 18 to 55 years with mid-portion Achilles tendinopathy were randomised to receive eccentric calf muscle exercises with either customised foot orthoses (intervention group) or sham foot orthoses (control group). Allocation to intervention was concealed. The Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire was completed at baseline, then at 1, 3, 6 and 12 months, with 3 months being the primary end point. Differences between groups were analysed using intention to treat with analysis of covariance. RESULTS: After randomisation into the customised foot orthoses group (n = 67) or sham foot orthoses group (n = 73), there was 70.7% follow-up of participants at 3 months. There were no significant differences between groups at any time point. At 3 months, the mean (SD) VISA-A score was 82.1 (16.3) and 79.2 (20.0) points for the customised and sham foot orthosis groups, respectively (adjusted mean difference (95% CI) 2.6 (-2.9 to 8.0), p = 0.353). There were no clinically meaningful differences between groups in any of the secondary outcome measures. CONCLUSIONS: Customised foot orthoses, prescribed according to the protocol in this study, are no more effective than sham foot orthoses for reducing symptoms and improving function in people with mid-portion Achilles tendinopathy undergoing an eccentric calf muscle exercise programme. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry number ACTRN12609000829213.
Reproduced with permission from the BMJ Publishing Group.

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