Journal Article

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

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

2018

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Arthritis / Autopsies / Biomechanical Phenomena / Biomedicine / Bone surgery / Comparative analysis / Denmark / Disability Evaluation / Equivalence Trials as Topic / Exercise / Exercise therapy / Exercise Therapy - adverse effects / Exercise Therapy - methods / Health Sciences / Humans / Medical research / Medicine / Medicine & Public Health / Methods / Multicenter Studies as Topic / Muscle Strength / Orthopedics / Pain Measurement / Pain, Postoperative - diagnosis / Pain, Postoperative - etiology / Pain, Postoperative - physiopathology / Pain, Postoperative - prevention & control / Patient outcomes / Patients / Physical therapy / Physiotherapy / Postoperative Care - adverse effects / Postoperative Care - methods / Quality of Life / Randomized Controlled Trials as Topic / Range of motion / Range of Motion, Articular / Recovery of Function / Rehabilitation / Rotator cuff / Rotator Cuff - diagnostic imaging / Rotator Cuff - physiopathology / Rotator Cuff - surgery / Rotator Cuff Injuries - complications / Rotator Cuff Injuries - diagnosis / Rotator Cuff Injuries - physiopathology / Rotator Cuff Injuries - surgery / Rotator cuff repair / Rupture / Shoulder / Shoulder Joint - diagnostic imaging / Shoulder Joint - physiopathology / Shoulder Joint - surgery / Shoulder Pain - diagnosis / Shoulder Pain - etiology / Shoulder Pain - physiopathology / Shoulder Pain - prevention & control / Statistics for Life Sciences / Study Protocol / Surgeons / Tear / Time Factors / Treatment Outcome / Ultrasonography