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

Primary Purpose

Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Coactivation Strengthening
Regular Strengthening
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Rotator Cuff Tendinopathy, Exercises, Coactivation, Strengthening

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de Recherche du CHUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coactivation strengthening

Regular strengthening

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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).

Full Information

First Posted
July 12, 2016
Last Updated
May 2, 2019
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT02837848
Brief Title
Effect of Muscle Coactivation Strengthening for Rotator Cuff Tendinopathy
Acronym
coacticuff
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 Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Rotator Cuff Tendinopathy, Exercises, Coactivation, Strengthening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coactivation strengthening
Arm Type
Experimental
Arm Description
Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening.
Arm Title
Regular strengthening
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Coactivation Strengthening
Intervention Description
Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening.
Intervention Type
Procedure
Intervention Name(s)
Regular Strengthening
Intervention Description
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 Measure Information:
Title
Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH)
Description
DASH is a self-reported questionnaire of 30 items measuring physical disability and symptoms. (St-Pierre et al., 2015; Roy et al., 2009)
Time Frame
Baseline - six weeks
Secondary Outcome Measure Information:
Title
Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH)
Description
DASH is a self-reported questionnaire of 30 items measuring physical disability and symptoms. (St-Pierre et al., 2015; Roy et al., 2009)
Time Frame
Baseline - three, 12, 18 and 24 weeks
Title
Change in pain (Visual Analogue Scale - VAS)
Description
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)
Time Frame
Baseline - three, six, 12, 18 and 24 weeks
Title
Change in quality of life/Function (Western Ontario Rotator Cuff Index - WORC)
Description
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)
Time Frame
Baseline - three, six, 12, 18 and 24 weeks
Title
Impression of Change (Patient Global Impression of Change - PGIC)
Description
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)
Time Frame
at three, six, 12, 18 and 24 weeks
Title
Change in subacromial distance (ultrasound scanner)
Description
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)
Time Frame
Baseline - six weeks
Title
Isometric strength (manual dynamometer)
Description
The isometric strength of flexion, abduction, internal and external rotation movements will be perform with a MicroFET manual dynamometer (Hoggan Health Industries, USA).
Time Frame
Baseline - six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaly Gaudreault, Ph.D.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche du CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Effect of Muscle Coactivation Strengthening for Rotator Cuff Tendinopathy

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