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Progressive Active Exercise After Surgical Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Progressive early passive and active movement
Limited early passive movement
Sponsored by
Marius Henriksen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Bispebjerg and Frederiksberg Hospitals
  • Herlev and Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progressive early passive and active movement

Limited early passive movement

Arm Description

Active exercise starts one week after surgery.

Active exercise starts six weeks after surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Change from baseline in Disability Arm Shoulder Hand (DASH)
Global Rating Scale (GRS)
Global perceived treatment effect
Change from baseline in Numeric Pain Rating Scale (NPRS)
Change from baseline in Shoulder Range of Motion (ROM)
Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption
Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.

Full Information

First Posted
November 15, 2016
Last Updated
November 20, 2020
Sponsor
Marius Henriksen
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1. Study Identification

Unique Protocol Identification Number
NCT02969135
Brief Title
Progressive Active Exercise After Surgical Rotator Cuff Repair
Official Title
Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2017 (Actual)
Primary Completion Date
May 10, 2020 (Actual)
Study Completion Date
May 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marius Henriksen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive early passive and active movement
Arm Type
Experimental
Arm Description
Active exercise starts one week after surgery.
Arm Title
Limited early passive movement
Arm Type
Active Comparator
Arm Description
Active exercise starts six weeks after surgery.
Intervention Type
Behavioral
Intervention Name(s)
Progressive early passive and active movement
Intervention Description
Post-surgical physical therapy including active exercise
Intervention Type
Behavioral
Intervention Name(s)
Limited early passive movement
Intervention Description
Post-surgical physical therapy including passive mobilisation
Primary Outcome Measure Information:
Title
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Time Frame
6 and 52 weeks
Title
Change from baseline in Disability Arm Shoulder Hand (DASH)
Time Frame
6, 12 and 52 weeks
Title
Global Rating Scale (GRS)
Description
Global perceived treatment effect
Time Frame
6, 12 and 52 weeks
Title
Change from baseline in Numeric Pain Rating Scale (NPRS)
Time Frame
6, 12 and 52 weeks
Title
Change from baseline in Shoulder Range of Motion (ROM)
Time Frame
6, 12 and 52 weeks
Title
Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption
Description
Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.
Time Frame
12 and 52 weeks
Other Pre-specified Outcome Measures:
Title
Ultrasound imaging of rotator cuff tendons
Description
Assessment of possible re-ruptures of tendons
Time Frame
6 weeks
Title
Ultrasound Imaging of rotator cuff tendons
Description
Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons
Time Frame
52 weeks
Title
Return to work
Description
Patient-reported time (days) til return to full work capacity.
Time Frame
6 and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Bispebjerg and Frederiksberg Hospitals
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Herlev and Gentofte Hospital
City
Copenhagen
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33471547
Citation
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.
Results Reference
derived
PubMed Identifier
30176943
Citation
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.
Results Reference
derived

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Progressive Active Exercise After Surgical Rotator Cuff Repair

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