Abstract
BackgroundAnterior shoulder dislocation is a common injury and may have considerable impact on shoulder-related quality of life (QoL). If not warranted for initial stabilising surgery, patients are mostly left with little to no post-traumatic rehabilitation. This may be due to lack of evidence-based exercise programmes. In similar, high-impact injuries (e.g. anterior cruciate ligament tears in the knee) neuromuscular exercise has shown large success in improving physical function and QoL. Thus, the objective of this trial is to compare a nonoperative neuromuscular exercise shoulder programme with standard care in patients with traumatic anterior shoulder dislocations (TASD).Methods/designRandomised, assessor-blinded, controlled, multicentre trial. Eighty patients with a TASD will be recruited from three orthopaedic departments in Denmark. Patients with primary or recurrent anterior shoulder dislocations due to at least one traumatic event will be randomised to 12 weeks of either a standardised, individualised or physiotherapist-supervised neuromuscular shoulder exercise programme or standard care (self-managed shoulder exercise programme). Patients will be stratified according to injury status (primary or recurrent). Primary outcome will be change from baseline to 12 weeks in the patient-reported QoL outcome questionnaire, the Western Ontario Shoulder Instability Index (WOSI).DiscussionThis trial will be the first study to compare the efficacy and safety of two different nonoperative exercise treatment strategies for patients with TASD. Moreover, this is also the first study to investigate nonoperative treatment effects in patients with recurrent shoulder dislocations. Lastly, this study will add knowledge to the shared decision-making process of treatment strategies for clinical practice.Trial registrationClinicalTrials.gov, identifier: NCT02371928. Registered on 9 February 2015 at the National Institutes of Health Clinical Trials Protocol Registration System.
Highlights
Anterior shoulder dislocation is a common injury and may have considerable impact on shoulderrelated quality of life (QoL)
Following a first-time traumatic anterior shoulder dislocations (TASD), the risk for recurrent dislocations is high due to pathophysiological changes in the shoulder joint [8] with mean risk rates estimated to vary between 39% and 67% [4, 9, 10]
Three randomised controlled trials (RCTs) investigating the effect of nonoperative versus operative treatment in patients with primary TASD show that early operative reconstruction of the anterior capsulolabral complex is superior to nonoperative treatment in reducing redislocation rates [20,21,22]
Summary
Traumatic anterior shoulder dislocation is common and may decrease shoulder-related QoL The aim of this randomised controlled clinical trial is to evaluate the efficacy and safety of a 12-week, structured, neuromuscular shoulder exercise programme versus 12 weeks of selfmanaged shoulder rehabilitation in patients with TASDs measured on the WOSI questionnaire. The current study will shed light on the effect of nonoperative treatment for patients with primary and recurrent anterior shoulder dislocations and provide foundation for nonoperative treatment guidelines. No matter the treatment (operative as well as nonoperative), fear of movement and reinjury, mood, social support and self-motivation has shown to greatly influence the decision on return to sport [14] Aspects like these are only covered by patient-reported outcomes, supporting the use of a patient-reported outcome as primary treatment effect measure in the current trial.
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