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).
abstract: 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).
  
  
  
  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).
  
  
  
  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.
  
  
  
  ClinicalTrials.gov, identifier: NCT02371928 . Registered on 9 February 2015 at the National Institutes of Health Clinical Trials Protocol Registration System.
authors.affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. heshoj@health.sdu.dk.|Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark. heshoj@health.sdu.dk.|Odense Quality of Life Research Center, Department of Haematology, Odense University Hospital, Odense, Denmark. heshoj@health.sdu.dk.
authors.forename: Henrik
authors.initials: H
authors.lastname: Eshoj
authors.affiliation: Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.|Orthopaedic Surgery Research Unit, Aalborg University Hospital, Aalborg, Denmark.
authors.forename: Sten
authors.initials: S
authors.lastname: Rasmussen
authors.affiliation: Department of Orthopaedics and Traumatology, Odense University Hospital, Odense, Denmark.
authors.forename: Lars Henrik
authors.initials: LH
authors.lastname: Frich
authors.affiliation: Shoulder Sector, Orthopedic Department, South-West Jutland Hospital, Esbjerg, Denmark.
authors.forename: Inge
authors.initials: I
authors.lastname: Hvass
authors.affiliation: Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
authors.forename: Robin
authors.initials: R
authors.lastname: Christensen
authors.affiliation: Shoulder Sector, Orthopaedic Department, Aalborg University Hospital, Farsoe, Denmark.
authors.forename: Steen Lund
authors.initials: SL
authors.lastname: Jensen
authors.affiliation: Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark.
authors.forename: Jens
authors.initials: J
authors.lastname: Søndergaard
authors.affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
authors.forename: Karen
authors.initials: K
authors.lastname: Søgaard
authors.affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.|Institute of Occupational Therapy, Physiotherapy and Radiography, Department of Health Sciences, Bergen University College, Bergen, Norway.
authors.forename: Birgit
authors.initials: B
authors.lastname: Juul-Kristensen
mesh_terms: D000293:Adolescent; D000328:Adult; D001696:Biomechanical Phenomena; D000066491:Clinical Decision-Making; D002985:Clinical Protocols; D003718:Denmark; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007593:Joint Instability / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011788:Quality of Life; D016059:Range of Motion, Articular; D020127:Recovery of Function; D012008:Recurrence; D012107:Research Design; D012783:Shoulder Dislocation / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012785:Shoulder Joint / Q000503:physiopathology*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Dislocation; Instability; Neuromuscular exercise; Nonoperative treatment; Physiotherapy; Shoulder