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TendinopathycoacticuffNCT02837848

Effect of Muscle Coactivation Strengthening for Rotator Cuff Tendinopathy

A study testing Coactivation Strengthening and Regular Strengthening in people with Tendinopathy, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Tendinopathy
What is being tested?
Coactivation Strengthening and Regular Strengthening
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteCanada
Study dates
Jul 2016to 1 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre de Recherche du CHUS

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

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

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.

Read more

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.

Conditions
Tendinopathy
Being tested
Coactivation Strengthening, Regular Strengthening
Keywords
Rotator Cuff Tendinopathy, Exercises, Coactivation, Strengthening
Medical subject headings
Tendinopathy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coactivation StrengtheningProcedure or surgery

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

  • Regular StrengtheningProcedure or surgery

    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.

Study groups in NCT02837848
Study groupRoleWhat they receive
Coactivation strengtheningExperimentalCoactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening.
Receives: Procedure: Coactivation Strengthening
Regular strengtheningActive comparatorRegular strengthening implies external rotation, internal rotation, flexion and abduction of the gleno-humeral joint and scapular protraction and retraction of the scapulothoracic joint strengthening.
Receives: Procedure: Regular Strengthening

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline - six weeks

Secondary outcomes (6)
  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)

    Measured: Baseline - three, 12, 18 and 24 weeks

  2. 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)

    Measured: Baseline - three, six, 12, 18 and 24 weeks

  3. 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)

    Measured: Baseline - three, six, 12, 18 and 24 weeks

  4. 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)

    Measured: at three, six, 12, 18 and 24 weeks

  5. 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)

    Measured: Baseline - six weeks

  6. 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).

    Measured: Baseline - six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionOct 2017
  4. Study completion1 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02837848
Sponsor's protocol ID
2017-1404
Acronym
coacticuff
Status last verified
May 2019
First submitted
12 Jul 2016
Last updated
6 May 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 15769790
  • 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.

    PubMed 22005869
  • 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.

    PubMed 15570226
  • 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.

    PubMed 15713296
  • 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.

    PubMed 22607807
  • 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.

    PubMed 23525552
  • 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.

    PubMed 25990445
  • 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.

    PubMed 19405008
  • 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.

    PubMed 18055266
  • 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.

    PubMed 19836206
  • 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.

    PubMed 15273525
  • 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.

    PubMed 30501388

Questions about this trial

What is this clinical trial studying?

A study testing Coactivation Strengthening and Regular Strengthening in people with Tendinopathy, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in function (Disabilities of Arm, Shoulder and Hand Questionnaire - DASH) (time frame: Baseline - six weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02837848, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.

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