NCT02837848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

July 12, 2016

Last Update Submit

May 2, 2019

Conditions

Keywords

Rotator Cuff TendinopathyExercisesCoactivationStrengthening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Coactivation strengthening

EXPERIMENTAL

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

Procedure: Coactivation Strengthening

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.

Procedure: Regular Strengthening

Interventions

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

Coactivation 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.

Regular strengthening

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (12)

  • Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005 Jun;44(6):800-5. doi: 10.1093/rheumatology/keh598. Epub 2005 Mar 15.

    PMID: 15769790BACKGROUND
  • Papadonikolakis A, McKenna M, Warme W, Martin BI, Matsen FA 3rd. Published evidence relevant to the diagnosis of impingement syndrome of the shoulder. J Bone Joint Surg Am. 2011 Oct 5;93(19):1827-32. doi: 10.2106/JBJS.J.01748.

    PMID: 22005869BACKGROUND
  • MacDermid JC, Ramos J, Drosdowech D, Faber K, Patterson S. The impact of rotator cuff pathology on isometric and isokinetic strength, function, and quality of life. J Shoulder Elbow Surg. 2004 Nov-Dec;13(6):593-8. doi: 10.1016/j.jse.2004.03.009.

    PMID: 15570226BACKGROUND
  • Graichen H, Hinterwimmer S, von Eisenhart-Rothe R, Vogl T, Englmeier KH, Eckstein F. Effect of abducting and adducting muscle activity on glenohumeral translation, scapular kinematics and subacromial space width in vivo. J Biomech. 2005 Apr;38(4):755-60. doi: 10.1016/j.jbiomech.2004.05.020.

    PMID: 15713296BACKGROUND
  • Hanratty CE, McVeigh JG, Kerr DP, Basford JR, Finch MB, Pendleton A, Sim J. The effectiveness of physiotherapy exercises in subacromial impingement syndrome: a systematic review and meta-analysis. Semin Arthritis Rheum. 2012 Dec;42(3):297-316. doi: 10.1016/j.semarthrit.2012.03.015. Epub 2012 May 18.

    PMID: 22607807BACKGROUND
  • Beaudreuil J, Lasbleiz S, Aout M, Vicaut E, Yelnik A, Bardin T, Orcel P. Effect of dynamic humeral centring (DHC) treatment on painful active elevation of the arm in subacromial impingement syndrome. Secondary analysis of data from an RCT. Br J Sports Med. 2015 Mar;49(5):343-6. doi: 10.1136/bjsports-2012-091996. Epub 2013 Mar 23.

    PMID: 23525552BACKGROUND
  • St-Pierre C, Dionne CE, Desmeules F, Roy JS. Reliability, validity, and responsiveness of a Canadian French adaptation of the Western Ontario Rotator Cuff (WORC) index. J Hand Ther. 2015 Jul-Sep;28(3):292-8; quiz 299. doi: 10.1016/j.jht.2015.02.001. Epub 2015 Feb 14.

    PMID: 25990445BACKGROUND
  • Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum. 2009 May 15;61(5):623-32. doi: 10.1002/art.24396.

    PMID: 19405008BACKGROUND
  • Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.

    PMID: 18055266BACKGROUND
  • Ekeberg OM, Bautz-Holter E, Keller A, Tveita EK, Juel NG, Brox JI. A questionnaire found disease-specific WORC index is not more responsive than SPADI and OSS in rotator cuff disease. J Clin Epidemiol. 2010 May;63(5):575-84. doi: 10.1016/j.jclinepi.2009.07.012.

    PMID: 19836206BACKGROUND
  • Desmeules F, Minville L, Riederer B, Cote CH, Fremont P. Acromio-humeral distance variation measured by ultrasonography and its association with the outcome of rehabilitation for shoulder impingement syndrome. Clin J Sport Med. 2004 Jul;14(4):197-205. doi: 10.1097/00042752-200407000-00002.

    PMID: 15273525BACKGROUND
  • Boudreau N, Gaudreault N, Roy JS, Bedard S, Balg F. The Addition of Glenohumeral Adductor Coactivation to a Rotator Cuff Exercise Program for Rotator Cuff Tendinopathy: A Single-Blind Randomized Controlled Trial. J Orthop Sports Phys Ther. 2019 Mar;49(3):126-135. doi: 10.2519/jospt.2019.8240. Epub 2018 Nov 30.

MeSH Terms

Conditions

TendinopathyMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesBehavior

Study Officials

  • Nathaly Gaudreault, Ph.D.

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 20, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2017

Study Completion

February 1, 2018

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations