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

Y1 - 2018

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.TRIAL REGISTRATION: ClinicalTrials.gov, NCT02969135 . Registered on 15 November 2016.

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.TRIAL REGISTRATION: ClinicalTrials.gov, NCT02969135 . Registered on 15 November 2016.

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

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 470

ER -