跳至主要内容
临床试验/NCT04154592
NCT04154592已完成不适用

The Effect of Humeral Head Depressor Muscle Co-Activation Training on Functional Outcomes in Patients Undergoing Arthroscopic Shoulder Surgery After Middle-Size Rotator Cuff Muscle Tear

Hacettepe University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Visual Analogue Scale (Pain)

研究概览

简要总结

Recent systematic reviews, and meta-analyses concluded that rotator cuff and scapular strengthening exercises should be included in rehabilitation programs for patients with middle-size rotator cuff muscle tear. Superior translation of the humeral head is one of the factors adversely affecting this rehabilitation process. Aside from rotator cuff muscles, opposition of superior humeral head translation can be achieved by the glenohumeral adductors (i.e. pectoralis major, latissimus dorsi muscles, and teres major), which act as humeral head depressors by means of the medio-inferior vector created by the orientation of their tendons. Recruitment of the glenohumeral adductors has been shown to decrease subacromial narrowing in elevated arms in asymptomatic individuals, and is thought to be a coping mechanism to decrease pain in individuals with rotator cuff tear. However, to the best of our knowledge, the efficacy of humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear has never been evaluated in patients with middle-size rotator cuff muscle tear. Since recruitment of those muscles could prevent a decrease in subacromial space during arm elevation, it could potentially lead to improved exercise performance, earlier benefits and better treatment outcomes compared to routine rotator cuff strengthening exercises. Thus, the aim of this study was to investigate the efficacy of the humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear.

详细描述

Shoulder pain is one of the most common types of musculoskeletal pain syndroms in the general population as its prevalence has been estimated between 7% and 26% and its annual incidence between 0.9% and 2.5%. Rotator cuff tear is one of the most common causes of painful shoulders. Lack of coordination or weakness of scapulothoracic and scapulohumeral muscles is one of the main factors thought to lead to muscle tears in shoulder. More specifically, the inability of the scapular muscles to achieve superior rotation and posterior tilt, as well as the failure of rotator cuff muscles to counter the superior humeral head translation imposed by deltoid contraction can lead to impingement of the subacromial soft tissues while performing overhead dynamic tasks. This increases the rotator cuff tears' prevalance. Aside from rotator cuff muscles, opposition of superior humeral head translation can be achieved by the glenohumeral adductors (i.e. pectoralis major, latissimus dorsi muscles, and teres major), which act as humeral head depressors by means of the medio-inferior vector created by the orientation of their tendons. Recruitment of the glenohumeral adductors has been shown to decrease subacromial narrowing in elevated arms in asymptomatic individuals, and is thought to be a coping mechanism to decrease pain in individuals with rotator cuff tear. However, to the best of our knowledge, the efficacy of humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear has never been evaluated in patients with middle-size rotator cuff muscle tear. Since recruitment of those muscles could prevent a decrease in subacromial space during arm elevation, it could potentially lead to improved exercise performance, earlier benefits and better treatment outcomes compared to routine rotator cuff strengthening exercises. Thus, the aim of this study was to investigate the efficacy of the humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear.

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 (Care Provider)

盲法说明

Single blinded

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •the presence of middle-sized (1-3 cm) rotator cuff muscle rupture,
  • •undergoing arthroscopic repair surgery,
  • •volunteering to participate in the study.

排除标准

  • •presence of diabetic mellitus,
  • •stage 3 and above according to Goutallier classification,
  • •presence of any contraindication for mobilization (hypermobility, trauma, inflammation, etc.),
  • •visual, verbal, cognitive defects (aphasia, unilateral neglect, etc.),
  • •the presence of any neurological problem,
  • •the presence of cervical disc hernia.

研究组 & 干预措施

Experimental Group

Experimental

In addition to the conservative treatment of the control group, humeral head depressor muscle co-activation training will be applied for 14 weeks.

干预措施: Humeral Head Depressor Muscle Co-Activation Training- Experimental Group (Other)

Control Group

Active Comparator

The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair will be used as guideline for rehabilitation of patients (Thigpen, C. A., Shaffer, M. A., Gaunt, B. W., Leggin, B. G., Williams, G. R., & Wilcox III, R. B. (2016). The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. Journal of shoulder and elbow surgery, 25(4), 521-535.).

干预措施: Control Group (Other)

结局指标

主要结局

Visual Analogue Scale (Pain)

时间窗: 14 weeks

The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The 11-point numeric scale ranges from '0' representing no pain to '10' representing pain as bad as you can imagine or worst pain imaginable. We use VAS to measure patient's perceived pain intensity during activity, at rest and at sleep during the last week preceding the assessment. MCIC for pain VAS is reported to be 2 points or 30%.

次要结局

  • The Constant-Murley Score(14 weeks)
  • Western Ontario Rotator Cuff Index (WORC)(14 weeks)
  • DASH Score(14 weeks)
  • Oxford Shoulder Score(14 weeks)
  • Range of Motion(14 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caner Karartı

Caner Karartı, Hacettepe University

Hacettepe University

研究点 (1)

Loading locations...

相似试验