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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Birgitte Hougs Kjær, S. Peter Magnusson, Susan Warming, Marius Henriksen, Michael Rindom Krogsgaard, Birgit Juul-Kristensen
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2839-5) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: Exercise therapy program for the CUT-N-MOVE trial. (PDF 53848 kb)
13063_2018_2839_MOESM1_ESM.pdf
Additional file 2: Exercise progression for the CUT-N-MOVE trial. (PDF 234 kb)
13063_2018_2839_MOESM2_ESM.pdf
Additional file 3: The SPIRIT checklist for the CUT-N-MOVE trial. (PDF 99 kb)
13063_2018_2839_MOESM3_ESM.pdf
Literatur
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