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临床试验/NCT02837848
NCT02837848已完成不适用

Effect of Adding Muscle Coactivation to Regular Shoulder Strengthening Exercises on Function and Pain With Patients Suffering of Rotator Cuff Tendinopathy: A Single-Blind Randomized Controlled Trial

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年7月最近更新:
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
42
试验地点
2
主要终点
Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH)

研究概览

简要总结

Rotator cuff tendinopathy (RCT) is the most frequent cause of shoulder pain. RCT is frequently termed as impingement syndrome, based on the underlying mechanism in which the subacromial space soft tissues (subacromial bursa, rotator cuff tendons and long head of the biceps tendon) get encroached under the coracoacromial arch when the arm is elevated. RCT contributes in the decrease in quality of life and function, and in inducing work incapacities and sleep disorders.

Exercises, as conservative management, were shown to be effective in increasing function and in decreasing pain related to RCT. However, the lack of studies comparing different types of exercises (i.e. concentric, eccentric, scapular strengthening, proprioceptive, coactivation) is reported by many systematic reviews. One type of exercise, coactivation strengthening, could be more efficient. Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening. When theses muscles are recruited, the medio-inferior orientation of their tendons creates a force vector that limits the superior translation of the humeral head, thus limits the subacromial narrowing.

The aim of this study is to evaluate the efficacy of coactivation strengthening exercises in patient with RCT compared to regular strengthening exercises. Forty-two participants diagnosed with RCT by an orthopaedic surgeon following a standardized protocol will be randomised to either coactivation or regular strengthening exercises. Participants will perform a 6-week exercise protocols. Outcomes will be measured at baseline, and at three, six, 12, 18 and 24 weeks. The primary outcome is function assessed with the Disabilities of arm, shoulder and Hand (DASH) questionnaire. Secondary outcomes focus on pain (visual analog scale), quality of life (Western Ontario Rotator Cuff Index), impression of change (Patient Global Impression of Change), subacromial distance (ultrasonography) and muscular strength (manual dynamometer). Investigators expect that coactivation strengthening exercises will be more efficient over the short and long term.

This trial will provide data to guide clinicians in the treatment of RCT to reduce recovery time and to bring patients back as quickly as possible to work or usual function.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years old
  • Experienced shoulder pain > four weeks
  • Positive Painful Arc Test
  • Positive Neer or Hawkins Kennedy test
  • Pain at resisted isometric movement of abduction or external rotation

排除标准

  • Any other shoulder pathology
  • Rotator cuff complete tear
  • History of shoulder surgery
  • Any systemic inflammation or neurological condition
  • Received a corticosteroid injection < six weeks
  • Any known cognitive condition

研究组 & 干预措施

Coactivation strengthening

Experimental

Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening.

干预措施: Coactivation Strengthening (Procedure)

Regular strengthening

Active Comparator

Regular strengthening implies external rotation, internal rotation, flexion and abduction of the gleno-humeral joint and scapular protraction and retraction of the scapulothoracic joint strengthening.

干预措施: Regular Strengthening (Procedure)

结局指标

主要结局

Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH)

时间窗: Baseline - six weeks

DASH is a self-reported questionnaire of 30 items measuring physical disability and symptoms. (St-Pierre et al., 2015; Roy et al., 2009)

次要结局

  • Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH)(Baseline - three, 12, 18 and 24 weeks)
  • Change in pain (Visual Analogue Scale - VAS)(Baseline - three, six, 12, 18 and 24 weeks)
  • Change in quality of life/Function (Western Ontario Rotator Cuff Index - WORC)(Baseline - three, six, 12, 18 and 24 weeks)
  • Impression of Change (Patient Global Impression of Change - PGIC)(at three, six, 12, 18 and 24 weeks)
  • Change in subacromial distance (ultrasound scanner)(Baseline - six weeks)
  • Isometric strength (manual dynamometer)(Baseline - six weeks)

研究者

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

Nathaly Gaudreault

Professor

Université de Sherbrooke

研究点 (2)

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