A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Change in Western Ontario Shoulder Instability Index (WOSI)
研究概览
简要总结
This study is designed to investigate the efficacy and safety of a supervised neuromuscular exercise program versus a standard home exercise program for patients with post-traumatic symptomatic anterior shoulder instability.
Participants with at least one week of symptom duration are randomly assigned to either a 12-week structured, supervised Shoulder Instability Neuromuscular EXercise (SINEX) program versus a standard HOMe EXercise (HOMEX) program.
The H1-hypothesis is that the SINEX program results in a greater increase in quality of life and physical function than the HOMEX program at the primary endpoint at three months follow-up from baseline
详细描述
A common, and very painful, injury for individuals in their second and third decades is a traumatic dislocated shoulder. This injury accounts for almost 50% of all joint dislocations registered in the emergency departments. Due to post-traumatic laxity and injuries to the surrounding shoulder tissue, one major problem is the risk of developing a chronic recurrent instable shoulder affecting patients both physically and psychologically decreasing their overall quality of life.
Biomechanically, proprioceptive changes and decreased sensorimotor control are found in patients with post-traumatic shoulder instability inhibiting the ability to control and stabilize the glenohumeral joint. In other similar musculoskeletal disorders, recent studies clearly shows positive effects of progressive neuromuscular exercise.
Finally, no studies have yet investigated the effect of a structured, physical exercise-training regime based on neuromuscular principles targeting the shoulder joint.
This trial is performed as a randomized, assessor-blinded, controlled multi-center trial with cooperation from various shoulder outpatient clinics located at different hospitals in The Region of Southern and Northern Denmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-39
- •Minimum one radiographic verified anterior shoulder dislocation (total dissociation of the humeral head to the glenoid)
- •Limited ability to maintain a desired level of physical activity (sports/leisure/work) due to pain and/or symptoms in the affected shoulder within the latest week.
排除标准
- •Humeral fracture and/or bony bankart (visible on conventional radiographs at the time of presentation) warranted for surgery decided by the orthopedic (no other axial or appendicular musculoskeletal injury)
- •Prior surgery in affected shoulder joint
- •>5 anterior shoulder dislocations (verified by journal or subjective evaluation)
- •Suspected competing diagnosis (e.g. rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, schizophrenia, suicidal threatened, borderline personality disorder or obsessive compulsive disorder
- •Sensory and motor deficits in neck and shoulder
- •Inadequacy in written and spoken Danish
- •Not willing or able to attend 12 weeks of supervised exercise therapy
研究组 & 干预措施
Neuromuscular exercise program
A 12-week physiotherapeutic, supervised exercise program with focus on neuromuscular shoulder control besides incorporation of kinetic chain exercises.
The exercise program contains the following focal points: Scapula and glenohumeral setting/control, dynamic shoulder stability, muscle co-contractions (weight-bearing upper extremity exercises) and proprioceptive training.
干预措施: Neuromuscular exercise program (Other)
Standard home exercise program
One physiotherapeutic-supervised instruction in 12 weeks of active exercises for the rotator cuff and scapular muscles.
Information about the shoulder injury and how to avoid pain provoking movements besides future implications is given. Also, participants receives one phone call after six weeks of training from a physiotherapist to ensure good compliance and answer any questions that the patient may have.
干预措施: Standard home exercise program (Other)
结局指标
主要结局
Change in Western Ontario Shoulder Instability Index (WOSI)
时间窗: Primary: 3 months. Other: 12, 24 months
The patient reported outcome, WOSI, consists of four domains covering "Physical Symptoms", "Sport/Recreation/Work", "Lifestyle" and "Emotions" with 21-item questionnaires in all. Each item is scored using a horizontal visual scale ranging from 0 to 100 mm (0-2100, with 0 as the level of no trouble).
次要结局
- Number of changes in positive clinical tests for anterior shoulder instability(3 months)
- Change in shoulder joint position sense(3 months)
- Number of participants with adverse events(3 months)
- Change in the four sub-scales (domains) of WOSI(3,12, 24 months)
- Change in Patient Specific Functioning Scale(3 months)
- Change in Euro Qol 5D Index (EQ-5D)(3,12, 24 months)
- Global Perceived Effect(3 months)
- Change in Constant-Murley Shoulder Score(3 months)
- Change in Tampa Scale of Kinesiophobia(3,12, 24 months)
研究者
Henrik Eshoj
Msc, PhD. stud
University of Southern Denmark