Effect of Muscle Coactivation Strengthening for Rotator Cuff Tendinopathy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tendinopathy

Intervention / Treatment
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* Procedure: Coactivation Strengthening
* Procedure: Regular Strengthening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coactivation strengthening<br>Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening. | Procedure: Coactivation Strengthening<br>* Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening.<br>|
| Active Comparator: Regular strengthening<br>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. | Procedure: Regular Strengthening<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH) | DASH is a self-reported questionnaire of 30 items measuring physical disability and symptoms. (St-Pierre et al., 2015; Roy et al., 2009) | Baseline - six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH) | DASH is a self-reported questionnaire of 30 items measuring physical disability and symptoms. (St-Pierre et al., 2015; Roy et al., 2009) | Baseline - three, 12, 18 and 24 weeks | 
| Change in pain (Visual Analogue Scale - VAS) | VAS is a self-reported scale of 10 cm measuring the intensity of pain from 0 (no pain) to 10 cm (worst pain). (Dworkin et al., 2008) | Baseline - three, six, 12, 18 and 24 weeks | 
| Change in quality of life/Function (Western Ontario Rotator Cuff Index - WORC) | WORC index is a disease-specific questionnaire developed to measure health related quality-of-life of individuals suffering from RC disorders. It contains 21 items divided into five sections: physical symptoms, sports/recreation, work, lifestyle and emotions. (Ekeberg et al., 2010) | Baseline - three, six, 12, 18 and 24 weeks | 
| Impression of Change (Patient Global Impression of Change - PGIC) | PGIC is a single-item rating by participants of their response during a clinical trial using a seven-points rating scale between Very much worst and Very much improved. (Dworkin et al., 2008) | at three, six, 12, 18 and 24 weeks | 
| Change in subacromial distance (ultrasound scanner) | Subacromial distance is defined as the tangential distance between the upper part of the humeral head and the lower part of the acromion. Ultrasound Imaging will be performed with a 6-13 Hz linear array probe (Sonosite Turbo, Futjifilm). (Desmeules et al., 2004) | Baseline - six weeks | 
| Isometric strength (manual dynamometer) | The isometric strength of flexion, abduction, internal and external rotation movements will be perform with a MicroFET manual dynamometer (Hoggan Health Industries, USA). | Baseline - six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Tendinopathy, Exercises, Coactivation, Strengthening