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Gait retraining versus foot orthoses for patellofemoral pain: a pilot randomised clinical trial [with consumer summary]
Bonacci J, Hall M, Saunders N, Vicenzino B
Journal of Science and Medicine in Sport 2018 May;21(5):457-461
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; 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*

OBJECTIVES: To determine the feasibility of a clinical trial that compares a 6-week, physiotherapist-guided gait retraining program with a foot orthoses intervention in runners with patellofemoral pain. DESIGN: Pilot randomised controlled trial. METHODS: Runners aged 18 to 40 years with clinically diagnosed patellofemoral pain were randomly allocated to either a 6-week gait retraining intervention of increasing cadence and use of a minimalist shoe or prefabricated foot orthoses. Outcomes at baseline and 12-weeks included recruitment, retention, adherence, adverse events, global improvement, anterior knee pain scale, worst and average pain on a 100mm visual analogue scale. RESULTS: Of the 16 randomised participants, two withdrew prior to commencing treatment due to non-trial related matters (n = 1 from each group) and 14 completed the pilot trial. Minor calf muscle soreness was reported by 3 participants in the gait retraining group while no adverse events were reported in the foot orthoses group. There were no deviations from the treatment protocols. There was a large between-group difference favouring gait retraining at 12-weeks in the anterior knee pain scale and the worst pain in the past week, which was reflected in the number needed-to-treat of 2. CONCLUSIONS: This study supports the feasibility of a trial comparing gait retraining with foot orthoses and provides point estimates of effect that informs the design and planning of a larger clinical trial. It appears that a 6-week gait retraining program has a clinically meaningful effect on runners with patellofemoral pain when compared to an evidence-based treatment of foot orthoses.

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