NCT02969135

Brief Summary

Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. The National Patient Register in Denmark has registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase. A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of function due to pain and tissue weakness. Little is known about the effects of the postoperative training/rehabilitation, and this provides an unclear picture of the total treatment procedure of this condition. The Danish National Clinical Guidelines from 2013 recommend that these patients are offered rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for postoperative training is moderate- low. The past few years, there have been conducted 5 systematic reviews looking at different rehabilitation parameters after rotator cuff surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon healing or clinical outcome. They also conclude that there is a further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load in high-quality, adequately powered trials, also considering key outcomes such as return to work. Therefore, the aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial. Shortterm effects of physical function, pain, and quality of life will be studied as primary patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes in addition to the longterm effects of physical function, pain, and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 26, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

November 15, 2016

Last Update Submit

November 20, 2020

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Western Ontario Rotator Cuff Index (WORC)

    12 weeks

Secondary Outcomes (6)

  • Change from baseline in Western Ontario Rotator Cuff Index (WORC)

    6 and 52 weeks

  • Change from baseline in Disability Arm Shoulder Hand (DASH)

    6, 12 and 52 weeks

  • Global Rating Scale (GRS)

    6, 12 and 52 weeks

  • Change from baseline in Numeric Pain Rating Scale (NPRS)

    6, 12 and 52 weeks

  • Change from baseline in Shoulder Range of Motion (ROM)

    6, 12 and 52 weeks

  • +1 more secondary outcomes

Other Outcomes (3)

  • Ultrasound imaging of rotator cuff tendons

    6 weeks

  • Ultrasound Imaging of rotator cuff tendons

    52 weeks

  • Return to work

    6 and 52 weeks

Study Arms (2)

Progressive early passive and active movement

EXPERIMENTAL

Active exercise starts one week after surgery.

Behavioral: Progressive early passive and active movement

Limited early passive movement

ACTIVE COMPARATOR

Active exercise starts six weeks after surgery.

Behavioral: Limited early passive movement

Interventions

Progressive early passive and active movementBEHAVIORAL

Post-surgical physical therapy including active exercise

Progressive early passive and active movement
Limited early passive movementBEHAVIORAL

Post-surgical physical therapy including passive mobilisation

Limited early passive movement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men above 18 years
  • Operated due to traumatic full thickness RC-tear
  • Involving supraspinatus (full thickness and width)
  • Present with reduced arm elevation strength and pain
  • Clinical diagnosis verified by arthroscopy
  • Fully repairable RC-tear

You may not qualify if:

  • Patients with non-traumatic RC-tears of the shoulder
  • Patients with isolated teres minor or subscapularis tear
  • Patients with partial thickness/ width tear
  • Prior shoulder surgery (all shoulder joints)
  • Glenohumeral osteo arthrosis (OA), rheumatoid arthritis or periarthrosis
  • Inability to speak or read Danish
  • Inability to perform and maintain the physical training
  • Other condition negatively influencing compliance or conditions that in the opinion of the investigator puts a potential participant at increased risk or otherwise makes him/her unsuitable for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bispebjerg and Frederiksberg Hospitals

Copenhagen, 2400, Denmark

Location

Herlev and Gentofte Hospital

Copenhagen, 2730, Denmark

Location

Related Publications (3)

  • Kjaer BH, Svensson RB, Warming S, Peter Magnusson S. Supraspinatus Muscle and Tendon Characteristics 1 Year After Surgical Rotator Cuff Repair Compared With Contralateral Shoulder: Data From the CUT-N-MOVE Trial. Am J Sports Med. 2024 Jul;52(8):2082-2091. doi: 10.1177/03635465241255143. Epub 2024 Jun 11.

    PMID: 38860727DERIVED

  • Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.

    PMID: 33471547DERIVED

  • Kjaer BH, Magnusson SP, Warming S, Henriksen M, Krogsgaard MR, Juul-Kristensen B. Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial). Trials. 2018 Sep 3;19(1):470. doi: 10.1186/s13063-018-2839-5.

    PMID: 30176943DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 21, 2016

Study Start

February 26, 2017

Primary Completion

May 10, 2020

Study Completion

May 10, 2020

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations

DK(2)