Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial)

Birgitte Hougs Kjær, S Peter Magnusson, Susan Warming, Marius Henriksen, Michael Rindom Krogsgaard, Birgit Juul-Kristensen, Birgitte Hougs Kjær, S Peter Magnusson, Susan Warming, Marius Henriksen, Michael Rindom Krogsgaard, Birgit Juul-Kristensen

Abstract

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.

Keywords: Exercise therapy; Physiotherapy; Rehabilitation; Rotator cuff; Rupture; Shoulder; Tear.

Conflict of interest statement

Ethics approval and consent to participate

The Health Research Study Board for the Capital Region Denmark approved the study on the 18 October 2016 (H-16033995). The study will be conducted in accordance with the local research ethics committee requirements and the principles of the Declaration of Helsinki, thus informed consent will be obtained from all study participants.

Consent for publication

Informed consent for publication of identifiable human images provided in the additional files has been obtained.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Expected flow of patients through the study. PR, progressive rehabilitation; UC, usual care
Fig. 2
Fig. 2
Time schedule of enrollment, assessments and responsible trial personnel (Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT)). BHK, primary investigator; SW, co-author; N/A, not applicable; OA: outcome assessors; MD, medical doctor/ radiologist; WORC, Western Ontario Rotator Cuff Index; DASH, Disabilities Arm, Shoulder and Hand questionnaire; MRI, magnetic resonance imaging; GRS, Global Rating Scale; NPRS, numeric pain rating scale; ROM, range of motion; US, ultrasound

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