Jaggi Anju, Alexander Susan, Herbert Robert, Funk Lennard, Ginn Karen A
Discipline of Biomedical Science, Sydney Medical School, The University of Sydney, Sydney, Australia.
BMC Musculoskelet Disord. 2014 Dec 17;15:439. doi: 10.1186/1471-2474-15-439.
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.
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.
Study was registered with National Institutes of Health Clinical Trials Protocol Registration System in December 2012.ClinicalTrials.gov Identifier: NCT01751490.
肩关节不稳定是影响年轻人的常见问题。对于因高能量碰撞创伤导致肩关节脱位的患者，稳定手术联合物理治疗康复已被证明可降低再次发生肩关节脱位的几率，并改善生活质量，但对于存在肩部结构损伤的非创伤性肩关节不稳定患者，手术干预是否有益尚不清楚。这项随机对照临床试验的目的是确定在物理治疗康复基础上增加手术干预是否能改善非创伤性肩关节不稳定且关节软组织受损患者的治疗效果。
方法/设计：将招募140名参与者。邀请肩关节有不安全感（担忧）且非碰撞损伤所致、伴有肩关节不稳定体征的患者参与。同意参与的患者将接受肩关节镜检查。存在关节囊盂唇损伤的患者将通过隐蔽分配程序随机分为两组，一组在关节镜检查后立即进行稳定手术，另一组不进行额外手术。然后所有参与者将接受相同的术后物理治疗方案，为期6个月。在手术前评估结果（疼痛、功能障碍和肩关节脱位次数），并在随机分组后的6个月、12个月和24个月再次评估，同时收集参与者报告的改善情况。主要终点将是2年时的疼痛和功能障碍。参与者、临床工作人员（但不包括外科医生）和评估人员将对是否进行了稳定手术不知情。数据分析将基于意向性分析，重点是估计治疗效果。
本试验将通过确定对于伴有非创伤性肩关节不稳定的软组织肩部损伤患者，在开始物理治疗康复前是否应转诊进行稳定手术以确保最佳治疗效果，从而对临床决策产生直接且即时的影响。这反过来将确保有效、高效地利用稀缺的卫生资源来管理这种常见且常导致残疾的肌肉骨骼疾病。
该研究于2012年12月在国立卫生研究院临床试验方案注册系统注册。ClinicalTrials.gov标识符：NCT01751490。
