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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study)

Authors: Henrik Eshoj, Sten Rasmussen, Lars Henrik Frich, Inge Hvass, Robin Christensen, Steen Lund Jensen, Jens Søndergaard, Karen Søgaard, Birgit Juul-Kristensen

Published in: Trials | Issue 1/2017

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Abstract

Background

Anterior 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/design

Randomised, 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).

Discussion

This 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 registration

ClinicalTrials.gov, identifier: NCT02371928. Registered on 9 February 2015 at the National Institutes of Health Clinical Trials Protocol Registration System.
Appendix
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Metadata
Title
A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study)
Authors
Henrik Eshoj
Sten Rasmussen
Lars Henrik Frich
Inge Hvass
Robin Christensen
Steen Lund Jensen
Jens Søndergaard
Karen Søgaard
Birgit Juul-Kristensen
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1830-x

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