Improvement of Fatigue in Unstable Shoulder Through a Therapeutic Exercise Program in Physiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Quality of life (WOSI)
研究概览
简要总结
Background: Glenohumeral instability is a highly prevalent pathology; however, there is great controversy in its definition. Traditionally, structural problems such as labral injury or bone loss in the glenoid cavity were considered the main causes; but recently, it has been seen that motor control plays a very relevant role. This means that currently, there is a disparity of action protocols and the treatment of this pathology is a great challenge.
Aim: The primary aim of this study is to evaluate the effectiveness of a supervised multicomponent therapeutic exercise program in reducing multivariable fatigue in patients with instability of the glenohumeral joint.
Methods: A single-blind randomized controlled trial will be carried out, in which 12 adult patients who have suffered at least one episode of glenohumeral instability in the last year will be recruited, who will be randomized to the intervention group, which will carry out a multicomponent therapeutic exercise program supervised by physiotherapists (MoveUS Program); or to the control group, which will receive the usual care. All subjects will be evaluated at baseline, mid-treatment and at the end. In these evaluations, range of movement, maximum peak of isometric force, kinematic, physiological and psychometric fatigue, return to activity, motor control and number of recurrences will be assessed; as well as the quality of life measured through the Western Ontario Shoulder Instability Index, which will be the main outcome variable. A multivariate analysis will be performed through a statistical program.
Discussion: This study aims to determine if therapeutic exercise supervised by physiotherapists is capable of reducing multivariable fatigue, reducing the number of recurrences and improving quality of life; to be able to implement it in the future in public and private centers.
详细描述
The glenohumeral joint presents a high incidence of dislocation (15.3 - 56.3 per 100,000 people per year), which is often accompanied by injury to the glenoid labrum, which increases the number of patients with chronic glenohumeral instability. However, there is great controversy when it comes to giving a clear and agreed definition among experts, since the term "recurrent glenohumeral instability" has been used in the scientific literature to encompass a multitude of terms such as dislocation, subluxation, apprehension and instability.
The two common points found in most definitions are discomfort and excessive translation of the humeral head in the glenoid fossa.
Traditionally, biomechanics have attributed glenohumeral instability to structural defects, pointing to bone loss in the glenoid cavity and Hill-Sachs lesion as its main causes. Nonetheless, it has been shown that abnormal muscle activation patterns of the periarticular muscles of the shoulder may be the cause of said instability without the need for there is structural damage.
Taking this last clarification into account, in 2020 a consensus was reached among various experts in the field of shoulder surgery to establish a standard in the classification of functional shoulder instability (FSI), dividing it into two large groups defined as positional FSI, when the shoulder subluxation or dislocation occurs during arm movement and is reduced when returning to neutral position; and non-positional FSI, when this glenohumeral dislocation occurs with the shoulder in a neutral position.
Additionally, a subdivision is made based on the patient's ability to control the occurrence of the event: the controllable ones, when the subject is capable of producing and reducing the dislocation voluntarily, almost without symptoms; and uncontrollable when the episode of instability occurs involuntarily, causing more severe pain and functional impotence.
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)
盲法说明
An external physiotherapist will be used to supervise the intervention carried out, so that the evaluator does not know at any time which group each subject belongs
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having suffered at least one episode of glenohumeral instability in the last year.
- •Age between 18 and 64 years.
- •Have signed the informed consent.
- •Score equal to or less than 6 on the Instability Severity Index Score.
排除标准
- •Ethical or cultural barriers.
- •Lack of command of Spanish language.
- •Underlying diseases or concomitant treatments that may affect exercise capacity.
- •Participation in other clinical trials.
- •Score equal to or greater than 1800 on the Western Ontario Shoulder Instability Index.
结局指标
主要结局
Quality of life (WOSI)
时间窗: 12 weeks
Quality of life is the set of factors that contribute to a person's well-being. It will be assessed through the Western Ontario Shoulder Instability Index
次要结局
- Scapulo-humeral rhythm (ECH)(12 weeks)
- Return to play (RTP)(12 weeks)
- Number of recurrences (Nº REC)(12 weeks)
- Physiological fatigue (Ff)(12 weeks)
- Psychometric fatigue (Fp)(12 weeks)
- Glenohumeral stability (STAB)(12 weeks)
- Muscular fatigue (Mf)(12 weeks)
- Range of movement (ROM)(12 weeks)
- Kinematic fatigue (Fc)(12 weeks)
- Maximum peak of isometric force (FIM)(12 weeks)
研究者
Dr. Antonio I Cuesta-Vargas
Physiotherapist. PhD. Professor Department of Physiotherapy, Faculty of Health Sciences, University of Malaga
University of Malaga