Progressive Active Exercise After Surgical Rotator Cuff Repair
NCT ID: NCT02969135
Last Updated: 2020-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2017-02-26
2020-05-10
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Progressive early passive and active movement
Active exercise starts one week after surgery.
Progressive early passive and active movement
Post-surgical physical therapy including active exercise
Limited early passive movement
Active exercise starts six weeks after surgery.
Limited early passive movement
Post-surgical physical therapy including passive mobilisation
Interventions
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Progressive early passive and active movement
Post-surgical physical therapy including active exercise
Limited early passive movement
Post-surgical physical therapy including passive mobilisation
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Marius Henriksen
OTHER
Responsible Party
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Marius Henriksen
Professor
Locations
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Bispebjerg and Frederiksberg Hospitals
Copenhagen, , Denmark
Herlev and Gentofte Hospital
Copenhagen, , Denmark
Countries
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References
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Kjaer BH, Svensson RB, Warming S, Peter Magnusson S. Supraspinatus Muscle and Tendon Characteristics 1 Year After Surgical Rotator Cuff Repair Compared With Contralateral Shoulder: Data From the CUT-N-MOVE Trial. Am J Sports Med. 2024 Jul;52(8):2082-2091. doi: 10.1177/03635465241255143. Epub 2024 Jun 11.
Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
Kjaer BH, Magnusson SP, Warming S, Henriksen M, Krogsgaard MR, Juul-Kristensen B. Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial). Trials. 2018 Sep 3;19(1):470. doi: 10.1186/s13063-018-2839-5.
Other Identifiers
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FYS012
Identifier Type: -
Identifier Source: org_study_id