N of 1, two contemporary arm, randomised controlled clinical trial for bilateral epicondylitis: a new study design

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ObjectiveTo investigate the use of a novel study design in analysis of bilateral elbow pain.DesignN of 1, two contemporary arm, open label, randomised controlled clinical trial.SettingA clinical epidemiologist at a university hospital in Pavia, Italy.ParticipantsTwo elbows with epicondylitis.InterventionsAutologous platelet lysate versus “wait and see” strategy.Main outcome measuresVisual analogue scale for pain on elbow extension and resisted wrist extension.ResultsOver six months' follow-up, the patient experienced bilateral improvement in pain, but higher in the treated arm, with a drop in visual analogue scale for pain from 28 to 4 for right (control) arm (drop of 24 points) and from 67 to 10.5 for left (treated) arm (drop of 56.5 points).ConclusionsPlatelet lysate might (or might not) work. Competing interests and lack of blinding might be relevant issues in the interpretation of trial results. However, the new study design can be applied to a number of conditions such as bilateral sport or trauma injuries, bilateral otitis, or any condition affecting chiral organs or limbs.

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