Abstract
BACKGROUND: Shoulder instability is a common problem affecting young adults. Stabilization surgery followed by physiotherapy rehabilitation has been shown to reduce the chance of further episodes of shoulder dislocation and to improve quality of life in patients who sustain a shoulder dislocation as a result of a high collision trauma, but it is unclear if surgical intervention is beneficial for patients with atraumatic shoulder instability who have structural damage at the shoulder. The aim of this randomized controlled clinical trial is to determine if the addition of surgical intervention to physiotherapy rehabilitation improves outcomes for patients with atraumatic shoulder instability who have sustained soft tissue damage at their joint. METHODS/DESIGN: 140 participants will be recruited. Patients with feelings of insecurity (apprehension) at their shoulder joint, which is not the result of a collision injury, with physical signs of shoulder joint instability will be invited to participate. Consenting participants will undergo arthroscopic investigation of the shoulder joint. Patients with capsulolabral damage will be randomly allocated using a concealed allocation procedure to either stabilization surgery immediately following the arthroscopic examination or no additional surgical procedure. All participants will then receive the same postoperative physiotherapy protocol for up to 6 months. Outcomes (pain, functional impairment and number of shoulder dislocations sustained) will be evaluated prior to surgery and, together with participant-reported improvement, again at 6, 12 and 24 months after randomization. The primary endpoint will be pain and functional impairment at 2 years. Participants, clinical staff (but not surgeons) and assessors will be blind to whether stabilization surgery was performed. Data analysis will be conducted on an intention-to-treat basis with the focus on estimation of the effect. DISCUSSION: This trial will have a direct and immediate impact on clinical decision making by establishing if patients presenting with soft tissue shoulder damage associated with atraumatic shoulder instability should be referred for stabilization surgery before commencing physiotherapy rehabilitation in order to ensure optimal outcome. This in turn will ensure effective, efficient use of scarce health resources to manage this common often disabling musculoskeletal condition. TRIAL REGISTRATION: Study was registered with National Institutes of Health Clinical Trials Protocol Registration System in December 2012.ClinicalTrials.gov Identifier: NCT01751490.