Ultrasound-guided tendon fenestration versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: Protocol for a prospective, randomised, single blinded study

Type de document

Études primaires

Année de publication

2018

Langue

Anglais

Titre de la revue

BMJ Open

Résumé

Introduction Chronic lateral epicondylosis (CLE) of the elbow is a prevalent condition among middle-aged people with no consensus on optimal care management but for which surgery is generally accepted as a second intention treatment. Among conservative treatment options, ultrasound (US)-guided fenestration has shown encouraging results that should be explored before surgery is considered. The primary objective of this study is to compare the efficacy of US-guided fenestration with open-release surgery in patients with failure to improve following a minimum 6 months of conservative treatment.

Methods and analysis This study protocol entails a two-arm, single-blinded, randomised, controlled design. Sixty-four eligible patients with clinically confirmed CLE will be assigned to either US-guided fenestration or open-release surgery. Fisher’s exact test will be used to compare the proportion of patients reporting a change of 11/100 points or more in the Patient Rated Tennis Elbow Evaluation score at 6 months, according to an intention-to-treat analysis. Secondary analyses will compare the two treatment groups in terms of pain and disability, functional limitations at work, pain-free grip strength, medication burden, patients’ global impression of change and level of satisfaction at 6 weeks, 3, 6 and 12 months, using mixed linear models for repeated measures or Fisher’s exact test, as appropriate. Finally, recursive partitioning analyses will investigate US and elastography parameters as predictors of treatment success at 6 and 12 months. This data will contribute to evidence-based treatment guidelines for CLE and explore the value of imaging biomarkers to improve risk stratification plans and assist clinicians.

Mots-clés

Ténopathie, Tendon disease, Examen aux ultrasons, Ultrasonic examination, Épicondylite, Epicondylitis, Affection du coude, Elbow lesion, Prospective, Future trend

Numéro de projet IRSST

2015-0034

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