Open access Protocol Ultrasound-guided tendon fenestration BMJ Open: first published as 10.1136/bmjopen-2017-021373 on 9 June 2018. Downloaded from versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: protocol for a prospective, randomised, single blinded study Eugen Lungu,1,2 Philippe Grondin,3,4 Patrice Tétreault,3,4 François Desmeules,5,6 Guy Cloutier,2,7 Manon Choinière,7,8 Nathalie J Bureau1,2,7 To cite: Lungu E, Grondin P, ABSTRACT Strengths and limitations of this study Tétreault P, et al. Ultrasound- Introduction Chronic lateral epicondylosis (CLE) of guided tendon fenestration the elbow is a prevalent condition among middle-aged ► This is the first randomised trial to compare the ef- versus open-release surgery people with no consensus on optimal care management for the treatment of chronic ficacy of ultrasound (US)-guided fenestration and but for which surgery is generally accepted as a second lateral epicondylosis of open-release surgery for the treatment of chronic intention treatment. Among conservative treatment the elbow: protocol for a lateral epicondylosis (CLE). options, ultrasound (US)-guided fenestration has shown prospective, randomised, ► This is the first study to explore the predictive value encouraging results that should be explored before single blinded study. BMJ Open of shear-wave elastography in response to treat- surgery is considered. The primary objective of this study 2018;8:e021373. doi:10.1136/ ment by US-guided fenestration or open-release bmjopen-2017-021373 is to compare the efficacy of US-guided fenestration with surgery, at 6 and 12 months following intervention. open-release surgery in patients with failure to improve ► Prepublication history for ► This is the first study to prospectively evaluate the following a minimum 6 months of conservative treatment. this paper is available online. evolution of US findings, up to 12 months following Methods and analysis This study protocol entails a To view these files, please visit treatment of patients with CLE. the journal online (http:// dx. doi. two-arm, single-blinded, randomised, controlled design. ► While the generalisability of the results of this phase http://bmjopen.bmj.com/ Sixty-four eligible patients with clinically confirmed CLE org/ 10. 1136/ bmjopen- 2017- II study might be limited, the outcomes and evalua- 021373). will be assigned to either US-guided fenestration or tion of the processes used in this study will inform a open-release surgery. Fisher’s exact test will be used to multicenter, phase III definitive study. Received 29 December 2017 compare the proportion of patients reporting a change of Revised 20 March 2018 11/100 points or more in the Patient Rated Tennis Elbow Accepted 19 April 2018 Evaluation score at 6 months, according to an intention-to- treat analysis. Secondary analyses will compare the two INTRODUCTIon treatment groups in terms of pain and disability, functional Chronic lateral epicondylosis (CLE) of the limitations at work, pain-free grip strength, medication elbow, commonly known as tennis elbow or on 10 June 2018 by guest. Protected copyright. burden, patients’ global impression of change and level of epicondylitis, is a debilitating condition with a satisfaction at 6 weeks, 3, 6 and 12 months, using mixed prevalence of 1%–3% in the general popula- linear models for repeated measures or Fisher’s exact test, tion, most commonly affecting adults in their as appropriate. Finally, recursive partitioning analyses will fourth and fifth decades of life.1 The socio- investigate US and elastography parameters as predictors economic burden of this disorder is substan- of treatment success at 6 and 12 months. This data will tial, with a yearly absenteeism rate as high as contribute to evidence-based treatment guidelines for CLE 2 and explore the value of imaging biomarkers to improve 5% in the working age population. Affected risk stratification plans and assist clinicians. patients usually complain of pain just distal to Ethics and dissemination The study has been approved the lateral humeral epicondyle and are likely by the Research Ethics Board of our institution on 23 to have a history of repetitive upper limb March 2016 (REB 15.327). In case of important protocol movements or of prolonged manipulation of modifications, a new version of the protocol with heavy weights.1 2 The pathophysiology of CLE For numbered affiliations see appropriate amendments will be submitted to the REB for entails repetitive overuse, leading to micro- end of article. approval. Study results will be published in peer-reviewed tears and progressive degenerative changes journals and presented at local, national and international of the common extensor tendon, combined Correspondence to conferences. with ineffective healing mechanisms.3 Histo- Dr Nathalie J Bureau; Trial registration number NCT02710682. nathalie. bureau@ umontreal. ca pathological findings include collagen fibre Lungu E, et al. BMJ Open 2018;8:e021373. doi:10.1136/bmjopen-2017-021373 1 Open access disorganisation, neoangiogenesis, mucoid degeneration, recommending PRP injections for treatment of chronic BMJ Open: first published as 10.1136/bmjopen-2017-021373 on 9 June 2018. Downloaded from fibroplasia and dystrophic calcifications, with invariable tendinopathy.12–14 involvement of the extensor carpi radialis brevis (ECRB) component of the common extensor tendon.4 A CLE diag- Ultrasound (US)-guided tendon fenestration for CLE nosis is usually made clinically, with the elbow extended Tendon fenestration is a minimally invasive, low risk, and the forearm in pronation, by pain provocation on dry-needling technique performed under direct US visu- palpation of the region of the lateral epicondyle, or using alisation. After local anaesthesia of the skin and subcuta- a resisted wrist or middle finger extension manoeuvre.5 neous tissues, a needle is used to create micropunctures in the affected region of the tendon and to abrade the Treatment of CLE: many options, no clear guidelines adjacent periosteum. The goal is to disrupt areas of The treatment arsenal for CLE is vast; however, no tendinosis and cause local bleeding to stimulate physi- successful and universally accepted trajectory of care ological mechanisms of fibroblastic proliferation and has been established and patient management remains tendon healing through scar remodelling.15 Hence, the deficient in many cases. Well-conducted conservative rationale behind this treatment is to convert a chronic treatment that includes rest, stretching and strength- degenerative painful process into an acute inflamma- ening exercises with emphasis on eccentric movements, tory condition that can lead to tendon regeneration and combined with ergonomic interventions has been healing.16 Bleeding that occurs within the tendon during shown to provide pain relief in 80% of patients at 8–12 the procedure delivers growth factors and inflammatory months.6 7 However, this approach may necessitate a cells that are essential to initiate the first phase of tendon prolonged reduction in stressful activities or extended healing response. US-guided tendon fenestration has absences from work that involves movements of the wrist shown promising results in various chronic tendinop- extensors. Consequently, financial impacts are often athies including CLE,17 18 patellar19 and gluteal tend- important for workers and compliance with treatment inopathies.15 20 In a 2006 retrospective study, McShane may be suboptimal in those without compensated sick et al reported 63.6% excellent, 16.4% good, 7.3% fair leave. and 12.7% poor outcomes at a mean follow-up of 28 Corticosteroid injections are commonly used for the months, in 58 consecutive patients with CLE treated quick pain relief they provide, but studies have shown with US-guided tendon fenestration, combined with a that, in the majority of cases, pain relief and physical func- corticosteroid injection.21 Two years later, in a retrospec- tioning improvement is short termed, recurrence rate is tive study, the same authors reported on the results of high and prognosis may be worsened in the long term.8 9 US-guided tendon fenestration in a subsequent group Despite the growing evidence of their long-term inefficacy of 57 consecutive patients with 57.7% excellent, 34.6% and potential deleterious effects, corticosteroid injections good, 1.9% fair, 5.8% poor outcomes at a mean follow-up are still routinely used as part of the conservative manage- of 22 months and concluded that a concomitant corti- http://bmjopen.bmj.com/ ment of CLE, mainly because they are easy to administer, costeroid was not necessary. Comparison with other inexpensive and provide pain relief, although of short treatments aiming to increase growth factors within the duration. tendon and stimulate the physiological healing processes, Extracorporeal shockwave therapy may also be including PRP and autologous blood injections, is diffi- employed in the management of patients with CLE; cult since these procedures incorporate a fenestration however, systematic reviews have concluded that this technique. Mishra et al in a multicenter randomised trial, approach provides little to no benefit in the treatment compared fenestration alone to fenestration combined of chronic tendinopathy, including CLE, when compared with PRP injection in 119 patients with CLE. At 24-week on 10 June 2018 by guest. Protected copyright. with placebo.6 10 follow-up, the success rates in the PRP group (n=56) Hoskrud et al reviewed