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Progressive Active Exercise After Surgical Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT02969135
Recruitment Status : Completed
First Posted : November 21, 2016
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital

Brief Summary:

Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. The National Patient Register in Denmark has registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.

A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of function due to pain and tissue weakness. Little is known about the effects of the postoperative training/rehabilitation, and this provides an unclear picture of the total treatment procedure of this condition.

The Danish National Clinical Guidelines from 2013 recommend that these patients are offered rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for postoperative training is moderate- low. The past few years, there have been conducted 5 systematic reviews looking at different rehabilitation parameters after rotator cuff surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon healing or clinical outcome. They also conclude that there is a further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load in high-quality, adequately powered trials, also considering key outcomes such as return to work.

Therefore, the aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.

Shortterm effects of physical function, pain, and quality of life will be studied as primary patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes in addition to the longterm effects of physical function, pain, and quality of life.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Behavioral: Progressive early passive and active movement Behavioral: Limited early passive movement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up
Actual Study Start Date : February 26, 2017
Actual Primary Completion Date : May 10, 2020
Actual Study Completion Date : May 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progressive early passive and active movement
Active exercise starts one week after surgery.
Behavioral: Progressive early passive and active movement
Post-surgical physical therapy including active exercise

Active Comparator: Limited early passive movement
Active exercise starts six weeks after surgery.
Behavioral: Limited early passive movement
Post-surgical physical therapy including passive mobilisation




Primary Outcome Measures :
  1. Change from baseline in Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 6 and 52 weeks ]
  2. Change from baseline in Disability Arm Shoulder Hand (DASH) [ Time Frame: 6, 12 and 52 weeks ]
  3. Global Rating Scale (GRS) [ Time Frame: 6, 12 and 52 weeks ]
    Global perceived treatment effect

  4. Change from baseline in Numeric Pain Rating Scale (NPRS) [ Time Frame: 6, 12 and 52 weeks ]
  5. Change from baseline in Shoulder Range of Motion (ROM) [ Time Frame: 6, 12 and 52 weeks ]
  6. Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption [ Time Frame: 12 and 52 weeks ]
    Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.


Other Outcome Measures:
  1. Ultrasound imaging of rotator cuff tendons [ Time Frame: 6 weeks ]
    Assessment of possible re-ruptures of tendons

  2. Ultrasound Imaging of rotator cuff tendons [ Time Frame: 52 weeks ]
    Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons

  3. Return to work [ Time Frame: 6 and 52 weeks ]
    Patient-reported time (days) til return to full work capacity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women and men above 18 years
  • Operated due to traumatic full thickness RC-tear
  • Involving supraspinatus (full thickness and width)
  • Present with reduced arm elevation strength and pain
  • Clinical diagnosis verified by arthroscopy
  • Fully repairable RC-tear

Exclusion Criteria:

  • Patients with non-traumatic RC-tears of the shoulder
  • Patients with isolated teres minor or subscapularis tear
  • Patients with partial thickness/ width tear
  • Prior shoulder surgery (all shoulder joints)
  • Glenohumeral osteo arthrosis (OA), rheumatoid arthritis or periarthrosis
  • Inability to speak or read Danish
  • Inability to perform and maintain the physical training
  • Other condition negatively influencing compliance or conditions that in the opinion of the investigator puts a potential participant at increased risk or otherwise makes him/her unsuitable for participation.

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): NCT02969135


Locations
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Denmark
Bispebjerg and Frederiksberg Hospitals
Copenhagen, Denmark, 2400
Herlev and Gentofte Hospital
Copenhagen, Denmark, 2730
Sponsors and Collaborators
Marius Henriksen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marius Henriksen, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT02969135    
Other Study ID Numbers: FYS012
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries