Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Muscle Coactivation Strengthening for Rotator Cuff Tendinopathy (coacticuff)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837848
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Nathaly Gaudreault, Université de Sherbrooke

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tendinopathy Procedure: Coactivation Strengthening Procedure: Regular Strengthening Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: Coactivation strengthening
Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening.
Procedure: Coactivation Strengthening
Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening.

Active Comparator: Regular strengthening
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
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.




Primary Outcome Measures :
  1. Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH) [ Time Frame: 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)


Secondary Outcome Measures :
  1. Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH) [ Time Frame: Baseline - three, 12, 18 and 24 weeks ]
    DASH is a self-reported questionnaire of 30 items measuring physical disability and symptoms. (St-Pierre et al., 2015; Roy et al., 2009)

  2. Change in pain (Visual Analogue Scale - VAS) [ Time Frame: Baseline - three, six, 12, 18 and 24 weeks ]
    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)

  3. Change in quality of life/Function (Western Ontario Rotator Cuff Index - WORC) [ Time Frame: Baseline - three, six, 12, 18 and 24 weeks ]
    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)

  4. Impression of Change (Patient Global Impression of Change - PGIC) [ Time Frame: at three, six, 12, 18 and 24 weeks ]
    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)

  5. Change in subacromial distance (ultrasound scanner) [ Time Frame: Baseline - six weeks ]
    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)

  6. Isometric strength (manual dynamometer) [ Time Frame: Baseline - six weeks ]
    The isometric strength of flexion, abduction, internal and external rotation movements will be perform with a MicroFET manual dynamometer (Hoggan Health Industries, USA).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837848


Locations
Layout table for location information
Canada, Quebec
Centre de Recherche du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Layout table for investigator information
Principal Investigator: Nathaly Gaudreault, Ph.D. Université de Sherbrooke
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nathaly Gaudreault, Professor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02837848    
Other Study ID Numbers: 2017-1404
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nathaly Gaudreault, Université de Sherbrooke:
Rotator Cuff Tendinopathy
Exercises
Coactivation
Strengthening
Additional relevant MeSH terms:
Layout table for MeSH terms
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries