Progressive early passive and active movement
BehavioralPost-surgical physical therapy including active exercise
NCT Number: NCT02969135
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Bispebjerg and Frederiksberg Hospitals, Copenhagen, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Post-surgical physical therapy including active exercise
Post-surgical physical therapy including passive mobilisation
Time frame: 12 weeks
Time frame: 6 and 52 weeks
Time frame: 6, 12 and 52 weeks
Time frame: 6, 12 and 52 weeks
Global perceived treatment effect
Time frame: 6, 12 and 52 weeks
Time frame: 6, 12 and 52 weeks
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.
Time frame: 6 weeks
Assessment of possible re-ruptures of tendons
Time frame: 52 weeks
Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons
Time frame: 6 and 52 weeks
Patient-reported time (days) til return to full work capacity.
Marius Henriksen
Other
Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07689383
PRP Injection, Rotator Cuff Injuries
Kifissia, Attica, Greece
View Trial DetailsNCT05499897
Postoperative Recovery, Rotator Cuff Injuries
Van, Bardakçı, Turkey (Türkiye)
View Trial DetailsNCT03295994
Rotator Cuff Injuries, Rotator Cuff Tear
Phoenix, Arizona, United States
View Trial DetailsNCT07455474
Neurologic Manifestations, Pain
Mammoth Lakes, California, United States
View Trial Details