TY - JOUR
T1 - Progressive early passive and active exercise therapy after surgical rotator cuff repair
T2 - study protocol for a randomized controlled trial (the CUT-N-MOVE trial)
AU - Kjær, Birgitte Hougs
AU - Magnusson, S Peter
AU - Warming, Susan
AU - Henriksen, Marius
AU - Krogsgaard, Michael Rindom
AU - Juul-Kristensen, Birgit
PY - 2018/9/3
Y1 - 2018/9/3
N2 - Background: Rotator cuff tear is a common cause of shoulder disability and results in patients predominantly complaining of pain and loss of motion and strength. Traumatic rotator cuff tears are typically managed surgically followed by ~ 20 weeks of rehabilitation. However, the timing and intensity of the postoperative rehabilitation strategy required to reach an optimal clinical outcome is unknown. Early controlled and gradually increased tendon loading has been suggested to positively influence tendon healing and recovery. The aim of this trial is therefore to examine the effect of a progressive rehabilitation strategy on pain, physical function and quality of life compared to usual care (that limits tendon loading in the early postoperative phase) in patients who have a rotator cuff repair of a traumatic tear. Methods: The current study is a randomized, controlled, outcome-assessor blinded, multicenter, superiority trial with a two-group paralleled design. A total of 100 patients with surgically repaired traumatic rotator cuff tears will be recruited from up to three orthopedic departments in Denmark, and randomized to either a progressive early passive and active movement program or a limited early passive movement program (usual care). The primary outcome measure will be the change from pre-surgery to 12 weeks post-surgery in the Western Ontario Rotator Cuff Index questionnaire. Secondary outcomes include the Disabilities Arm, Shoulder and Hand questionnaire (DASH), range of motion, strength and tendon healing characteristics from ultrasound measurements at 12 months follow up. Discussion: We hypothesized that patients who receive the progressive rehabilitation strategy will benefit more with respect to pain reduction, physical function and quality of life than those who receive care as usual. If this is confirmed our study can be used clinically to enhance the recovery of patients with traumatic rotator cuff tear.
AB - Background: Rotator cuff tear is a common cause of shoulder disability and results in patients predominantly complaining of pain and loss of motion and strength. Traumatic rotator cuff tears are typically managed surgically followed by ~ 20 weeks of rehabilitation. However, the timing and intensity of the postoperative rehabilitation strategy required to reach an optimal clinical outcome is unknown. Early controlled and gradually increased tendon loading has been suggested to positively influence tendon healing and recovery. The aim of this trial is therefore to examine the effect of a progressive rehabilitation strategy on pain, physical function and quality of life compared to usual care (that limits tendon loading in the early postoperative phase) in patients who have a rotator cuff repair of a traumatic tear. Methods: The current study is a randomized, controlled, outcome-assessor blinded, multicenter, superiority trial with a two-group paralleled design. A total of 100 patients with surgically repaired traumatic rotator cuff tears will be recruited from up to three orthopedic departments in Denmark, and randomized to either a progressive early passive and active movement program or a limited early passive movement program (usual care). The primary outcome measure will be the change from pre-surgery to 12 weeks post-surgery in the Western Ontario Rotator Cuff Index questionnaire. Secondary outcomes include the Disabilities Arm, Shoulder and Hand questionnaire (DASH), range of motion, strength and tendon healing characteristics from ultrasound measurements at 12 months follow up. Discussion: We hypothesized that patients who receive the progressive rehabilitation strategy will benefit more with respect to pain reduction, physical function and quality of life than those who receive care as usual. If this is confirmed our study can be used clinically to enhance the recovery of patients with traumatic rotator cuff tear.
KW - Biomechanical Phenomena
KW - Denmark
KW - Disability Evaluation
KW - Exercise Therapy/adverse effects
KW - Humans
KW - Multicenter Studies as Topic
KW - Muscle Strength
KW - Pain Measurement
KW - Pain, Postoperative/diagnosis
KW - Postoperative Care/adverse effects
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Range of Motion, Articular
KW - Recovery of Function
KW - Rotator Cuff/diagnostic imaging
KW - Rotator Cuff Injuries/complications
KW - Shoulder Joint/diagnostic imaging
KW - Shoulder Pain/diagnosis
KW - Time Factors
KW - Treatment Outcome
KW - Ultrasonography
U2 - 10.1186/s13063-018-2839-5
DO - 10.1186/s13063-018-2839-5
M3 - Journal article
C2 - 30176943
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
M1 - 470
ER -