TY - JOUR
T1 - N of 1, two contemporary arm, randomised controlled clinical trial for bilateral epicondylitis
T2 - A new study design
AU - Scudeller, Luigia
AU - Del Fante, Claudia
AU - Perotti, Cesare
AU - Pavesi, Claudio Francesco
AU - Coscia, Davide
AU - Scotti, Valeria
AU - Tinelli, Carmine
PY - 2011/12/24
Y1 - 2011/12/24
N2 - Objective: To investigate the use of a novel study design in analysis of bilateral elbow pain. Design: N of 1, two contemporary arm, open label, randomised controlled clinical trial. Setting: A clinical epidemiologist at a university hospital in Pavia, Italy. Participants: Two elbows with epicondylitis. Interventions: Autologous platelet lysate versus "wait and see" strategy. Main outcome measures: Visual analogue scale for pain on elbow extension and resisted wrist extension. Results: Over 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). Conclusions: Platelet 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.
AB - Objective: To investigate the use of a novel study design in analysis of bilateral elbow pain. Design: N of 1, two contemporary arm, open label, randomised controlled clinical trial. Setting: A clinical epidemiologist at a university hospital in Pavia, Italy. Participants: Two elbows with epicondylitis. Interventions: Autologous platelet lysate versus "wait and see" strategy. Main outcome measures: Visual analogue scale for pain on elbow extension and resisted wrist extension. Results: Over 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). Conclusions: Platelet 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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U2 - 10.1136/bmj.d7653
DO - 10.1136/bmj.d7653
M3 - Article
C2 - 22187187
AN - SCOPUS:84859006158
VL - 343
JO - British Medical Journal
JF - British Medical Journal
SN - 0959-8146
IS - 7837
M1 - d7653
ER -