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

Abstract

IntroductionChronic 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 analysisThis 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.Ethics and disseminationThe study has been approved by the Research Ethics Board of our institution on 23 March 2016 (REB 15.327). In case of important protocol modifications, a new version of the protocol with appropriate amendments will be submitted to the REB for approval. Study results will be published in peer-reviewed journals and presented at local, national and international conferences.Trial registration numberNCT02710682.

Efficacy of ultrasound therapy for the treatment of lateral elbow tendinopathy (the UCICLET Trial): study protocol for a three-arm, prospective, multicentre, randomised controlled trial

“…Pain severity over the lateral humeral epicondyle greater than 30 mm on a 100 mm Visual Analogue Scale (VAS), provoked by at least two of the following: gripping, palpation, resisted wrist or middle finger extension, or stretching of forearm extensor muscles with reduced pain-free grip;16 49…”

“…This change will come about through proposed evidence-based treatment guidelines. There have been some ongoing clinical trials on LET treatment in recent years, [47][48][49] and our prospective randomised controlled trial (RCT) proposes to complement and add to this relevant and much needed scientific effort.…”

Management of lateral epicondylitis (tennis elbow)

“…Percutaneous needle fenestration (piercing the damaged part of the tendon with a needle) may be performed under local anaesthetic with or without ultrasound guidance 3435. It is often carried out in conjunction with platelet rich plasma or autologous blood injections.…”

“…Shockwave therapy is used for various tendinopathies, particularly in higher resource settings 37. Evidence to support its effectiveness in treating lateral epicondylitis is currently inconclusive; however, results from small RCTs suggest that it may be associated with reduced pain levels and improved grip strength compared with placebo 34…”

Regenerative Rehabilitation in Injuries of Tendons

“…На их эффективность влияют изменения в методике (инъекция под ультразвуковым контролем или по опознавательным точкам, объем инъекции, время проведения процедуры по отношению к моменту травмы, число процедур, количество лейкоцитов, использование активаторов) [9]. В настоящее время проводится рандомизированное клиническое исследование «Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis» (идентификационный номер NCT02710682) по сравнению эффективности фенестрации под ультразвуковым контролем и открытой хирургической операции у пациентов с хроническим латеральным эпикондилитом (теннисным бурситом) локтевого сустава без улучшения после минимального консервативного лечения (включая покой, эксцентрические и концентрические упражнения и инъекции глюкокортикоидов) в течение 6 мес [10].…”