A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study)
| Autor: | Sten Rasmussen, Steen Lund Jensen, Birgit Juul-Kristensen, Inge Hvass, Robin Professor Christensen, Jens Søndergaard, Lars Henrik Frich, Henrik Eshøj, Karen Søgaard |
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| Rok vydání: | 2017 |
| Předmět: |
Research design
Time Factors Denmark medicine.medical_treatment Exercise Therapy/adverse effects Medicine (miscellaneous) law.invention Study Protocol Disability Evaluation 0302 clinical medicine Clinical Protocols Quality of life Randomized controlled trial Recurrence law Surveys and Questionnaires Pharmacology (medical) 030212 general & internal medicine Range of Motion Articular Young adult Physiotherapy Rehabilitation Shoulder Joint Instability Exercise Therapy Biomechanical Phenomena Treatment Outcome Research Design Joint Instability Adult Neuromuscular exercise Shoulder medicine.medical_specialty Adolescent Clinical Decision-Making Nonoperative treatment Shoulder Dislocation/diagnosis Young Adult 03 medical and health sciences Physical medicine and rehabilitation Journal Article medicine Dislocation Humans Protocol (science) business.industry Shoulder Dislocation Joint Instability/diagnosis Recovery of Function 030229 sport sciences Anterior shoulder Shoulder Joint/physiopathology Clinical trial Quality of Life Physical therapy business |
| Zdroj: | Eshoj, H, Rasmussen, S, Frich, L H, Hvass, I, Christensen, R, Jensen, S L, Søndergaard, J, Søgaard, K & Juul-Kristensen, B 2017, ' A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability : study protocol for a randomised controlled trial (the SINEX study) ', Trials, vol. 18, no. 1, 90 . https://doi.org/10.1186/s13063-017-1830-x Eshøj, H, Rasmussen, S, Frich, L H, Hvass, I, Professor Christensen, R, Jensen, S L, Søndergaard, J, Søgaard, K & Juul-Kristensen, B 2017, ' A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability : study protocol for a randomised controlled trial (the SINEX study) ', Trials, vol. 18, 90 . https://doi.org/10.1186/s13063-017-1830-x Trials |
| ISSN: | 1745-6215 0237-1928 |
| DOI: | 10.1186/s13063-017-1830-x |
| Popis: | 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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1830-x) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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