Rehabilitation by Multifactorial Approach After a Latarjet Procedure : Prospective Single-center Randomized Study (MATASI-L)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Western Ontario Shoulder Instability Index (WOSI)
研究概览
简要总结
Kinesiophobia (fear of physical movement) is common after a previous shoulder dislocation and persists after one year, regardless of the occurrence of a recurrence. This kinesiophobia is associated with a lower level of physical activity and a lower return to sport. Increased kinesiophobia, combined with other psychological factors such as depression and fear of re-injury in patients with shoulder instability, results in poor outcomes after treatment. Given that there is currently no postoperative protocol that takes this psychological component into account, a new rehabilitation protocol focused on reducing kinesiophobia was recently designed as part of an international consensus study based on the method Delphi. This protocol includes a core set of evidence-based interventions aimed at regaining functional stability of the shoulder and reducing fear of recurrent dislocation and kinesiophobia. The goal of this study is to determine if we can reduce kinesiophobia in patients who have undergone stabilization surgery for anterior shoulder instability using this new rehabilitation protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or recurrent traumatic anterior dislocation of the shoulder
- •Indication of abutment according to Latarjet (arthroscopic or open sky)
- •Age: 18-67 years
- •Understanding of the French language spoken and written
- •Written informed consent (in accordance with to ICH-GCP guidelines)
排除标准
- •Posterior or multidirectional instability of the shoulder (Beighton score >5)
- •Age <18 or >67 years.
- •Patients with additional rotator cuff tear.
- •Patients with a history of surgery on either shoulder.
- •Patients with connective tissue disorders (eg Ehler-Danlos).
- •Patients with (current) anxiety disorders or using anxiolytic medications (eg, antipsychotics) (criterion based on patient record/indications).
- •Patients with neurological disorders or systemic disease.
- •Patients with inflammatory disease, rheumatoid arthritis or active malignancy.
- •Patients previously hospitalized for shoulder pain
- •Patients with upper tubercle fracture
- •Patients with motor neurological deficit
- •Pregnant or breastfeeding patient
- •Patient protected under protective measure
研究组 & 干预措施
Readaptation protocol with psychologic intervention
Patient have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) with addition of 4 consultations with a sports psychologist
干预措施: consultations with a psychologist (Other)
Convention readaptation protocol
Patients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure)
干预措施: Conventional reeducation (Other)
结局指标
主要结局
Western Ontario Shoulder Instability Index (WOSI)
时间窗: 6 months
self-evaluating shoulder instability quality of life score : 21 items. The patient is asked to grade the function of a specific item on a horizontal visual analog scale from 0 to 100 mm. Each question results in a number between 0 and 100 and the total score may be presented as a number between 0 and 2,100 points (where 0 represents no deficit and 2,100 the worst)
次要结局
- Patient's pain(6 months)
- ability to return to work(6 months)
- S-starts test (including psychologic evaluation)(6 months)
- Shoulder subjective value(6 months)
- ability to return to sport(6 months)
- Patient's kinesiophobia(6 months)